Casein-derived MKP × ADAS-cog total score: Primary null finding and gaps in CIs and clinical thresholds

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich existing total-score claim is being presented?Required	The selected wording is “Improved ADAS-cog total score”, with original subclaim grade D and a note that the baseline-adjusted result was null, P=0.302 and d=0.12. Absent subclaim score, status and axes are not filled with parent D30 values or axes. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Separate the selected ADAS-cog total score and subclaim grade from parent values	Material needed: The selected total score's effect of interest, population, visit and review of the claim boundary. Original subclaim absences and parent context are retained separately. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich population's cognitive results are these?Required	The population comprised 268 community-dwelling Japanese adults aged 40 or older without dementia. Results are not extended to people with dementia, all cognitive impairment, or other ages or regions. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Community-dwelling adults without dementia and eligibility scope	Material needed: Original eligibility and exclusion criteria, cognitive-status classification, baseline characteristics, comorbidities and medication, and direct comparisons in other populations. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionAre baseline scores distinguished from cognitive status?Required	Baseline total scores were MKP 4.08±2.17 and placebo 4.10±2.10. The absence of dementia and the scores are retained as separate information. These values are not used to newly establish normal cognition, MCI or dementia thresholds, or floor or ceiling effects. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Baseline total scores and clinical diagnosis	Material needed: Original data on score range and direction, population-specific cognitive classification, distributions and baseline clinical function. No new score conversion or diagnosis. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionIs the study ingredient equivalent to ordinary milk?Required	The original intervention was milk-casein-derived Met-Lys-Pro (MKP), 200 μg/day; MKP-containing casein-hydrolysate tablets were manufactured and supplied. This is not converted into an amount or equivalence of ordinary milk or other casein products. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	MKP and the casein-hydrolysate study product	Material needed: Original tablet composition, MKP quantification and manufacturing, other ingredients, adherence and product identity. The original dose identifies study exposure and is not consumption or product advice. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat were the control and group allocations?Required	268 participants were allocated to MKP 200 μg/day or dextrin placebo, 134 in each group. The summary does not establish actual placebo-tablet details, sensory matching, blinding or concurrent exposures. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Dextrin placebo and actual control conditions	Material needed: Original placebo composition, tablet count and expectations, concurrent diet and medication, contact, adherence and allocation concealment. The same effect is not transferred to other controls. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionIs 24-week study exposure distinguished from actual use and follow-up?Required	Original study exposure was 200 μg/day for 24 weeks. Actual exposure, adherence, discontinuation, visit-specific measurements and persistence after the study are not verified in detail. No new cumulative dose or number of days is calculated. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Duration, adherence and persistence after the study	Material needed: Group-specific actual exposure, adherence, discontinuation, measurement timing and poststudy follow-up. No long-term dementia-prevention or treatment instructions. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionDoes ITT for 268 participants mean everyone completed follow-up?Required	The existing evidence list records 268 randomized participants and ITT analysis (134/134). ITT is not recast as completion of 24 weeks by everyone or identical observed denominators for all outcomes. Actual completion, withdrawal and missingness are not verified in detail. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Allocation, analysis, completion, withdrawal and endpoint-specific denominators	Material needed: Group-specific flow diagrams and reasons for completion or withdrawal, observed and analyzed denominators for total scores and visits, and missing-data handling. No new withdrawal count, rate or measurement total is calculated. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat do the original allocation and blinding statements say?Required	The original Korean and English texts record computer block randomization, blinding of participants, physicians, assessors and analysts, and analysis by assigned group. The original design statement is retained; this is not a new comparison of procedures or data or an official RoB certification. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Computer block allocation and multiple blinding roles	Material needed: Original allocation-concealment and blinding implementation or unblinding records, intervention deviations, missingness and analysis processes. Company involvement and design strengths remain separate. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhich primary test was the total score?Required	The paper summary identifies the primary endpoint as ADAS-cog total score at 24 weeks. The preserved registration citation says ADAS-Jcog was the prespecified primary endpoint. No new external comparison of names, versions, exact measurement or hierarchy was performed. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	ADAS-cog total score and the registered ADAS-Jcog name	Material needed: Exact test version, total-score calculation and direction, measurement timing, and specifications in the paper, registration and protocol. Different names are not automatically treated as equivalent. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre before-and-after total scores separated from the between-group comparison?Required	Total scores were MKP 4.08±2.17 to 3.18±1.88 and placebo 4.10±2.10 to 3.43±2.10. These are retained separately from the original baseline-adjusted between-group P=0.302 and d=0.12. No new difference, ratio or CI is calculated from before-and-after values. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original total scores and baseline-adjusted effects	Material needed: Dispersion notation in the original table, group-specific analysis denominators, baseline-adjusted model, effect of interest and missing-data handling. The meaning of ± is not guessed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat do the null total-score finding and small d limit?Required	The original baseline-adjusted total-score result, P=0.302 and d=0.12, was judged null. It is not rejudged as an exactly zero effect, equivalence, noninferiority or exclusion of a clinically important benefit. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original P and d and unverified CIs and clinical importance	Material needed: Effect-estimate definition, 95% CI, prespecified externally validated clinical threshold, uncertainty and importance. No new effect, CI or hypothetical example. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionWere CIs and a prespecified clinical threshold reported?Required	The original material explains that a 95% CI for the primary endpoint and a prespecified externally validated clinical threshold were not reported, so a meaningful benefit could not be excluded. This original reporting limitation is not recast as a current rereading of the full paper. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Effect precision and clinical thresholds	Material needed: Original effect estimates and intervals, clinical-threshold setting, plans and analysis data, or separate confirmatory evidence. A sample size of 268 alone does not certify precision or exclusion of benefit. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWas improvement in both groups assigned to the ingredient?Required	The original reader answer and advertising interpretation attribute improvement in both groups to repeat testing and explain that it should not be assigned to a specific MKP effect. This retains the original interpretation, not a new mechanistic or causal verification. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Repeat testing and additional effects versus placebo	Material needed: Original information on repeat testing, practice and expectations, within- and between-group analyses, effect of interest and concurrent exposures. No new product effect is calculated from within-group change. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionDoes positive Orientation replace the failed total score?Required	The original statement is retained: Orientation P=0.022 is a disclosed secondary result but does not overturn the null primary total score. Total-score P, d, group values or CI limitations are not copied into Orientation results. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Separate the primary total score from the secondary subscale	Material needed: Original subscale results, hierarchy, prespecified plans, multiple comparisons, individual effects and CIs, and separate confirmation. These are not promoted into total-score or global-cognition efficacy. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionAre complete results for other subscales and tests available?Required	The preserved material describes the total score and Orientation. Other subscales and tests, the total number of tests, complete results and the multiplicity plan are not verified in detail. No new list or count of positive or null results is created. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Total score, individual subscales and other tests	Material needed: Complete result tables, measurement tools, registration, protocol, SAP, and testing or selective-reporting plans. Unread external material is not assumed to be unreported. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionWere total-score findings extended to dementia prevention or daily function?Required	The original population was adults without dementia and the primary endpoint was ADAS-cog total score at 24 weeks. The preserved scope provides no separate direct results for dementia incidence, daily function or replacement of treatment. These are not established from total scores or subscale signals. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Cognitive scores and clinical function or incidence outcomes	Material needed: Definitions, duration, group-specific denominators, effects and CIs for clinical function or dementia events actually measured, and direct longer-term follow-up. Unread material is not assumed to mean the outcome was not measured. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWere endpoints, visits or related sheets counted as separate replications?Required	Total score and Orientation are different outcomes from the same Yuda2020 report and 268-person, 24-week trial. The same people, groups, visits, subscales, registration and related sheets are not added as new independent trials or participants. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Relationships between total scores and subscales in the same report and participants	Material needed: Original analysis, registration and report identities and links between repeated measurements and cohorts. Document counts are distinguished from certified counts of unique trials or participants. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
18	Partly verified	Full text not readStored summary read	N18 · Harm-information gaps supplementing the efficacy tableWhat is the scope of the original serious-adverse-event statement?Supplementary	The original safety explanation states that no serious adverse event attributed to MKP was reported over 24 weeks and includes a milk-protein-allergy caution. The full preserved summary is retained; this is not extended to zero adverse events, long-term safety or safety in all populations. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Related SAEs over 24 weeks, other harms and allergy	Material needed: Group-specific AE and SAE collection methods, exposure and denominators, discontinuation, attribution, allergy populations and longer-term harms. No new product-consumption or treatment guidance. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat materials were actually read in this work?Required	The complete parent summary was read for production and preserved in its original form. Summary reading refers to the stored summary; the external abstract, full paper, UMIN registration, protocol and SAP remain unread in this work. The existence of a URL is not promoted into reading. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Preserved-summary reading and external paper or registration status	Material needed: Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre historical registration dates and primary-endpoint names distinguished from current reading?Required	The original Korean and English texts describe prospective registration, with disclosure on 2018-06-04 and a planned start on 2018-06-07. The registration citation describes prespecified ADAS-Jcog and manufacturer funding. Only original dates and statements are retained; actual start, versions and plan agreement are not newly verified. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	UMIN000032833 history and prespecified plans	Material needed: Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionWere protocol, SAP, subscale and multiplicity plans acquired?Required	Original registration and historical cross-checking statements are retained. The original protocol and SAP, versions and dates, subscale and multiplicity plans, and clinical thresholds have not been read in this work. A registration statement about the primary endpoint does not establish all secondary plans. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Separate evidence for prespecified plans, analyses and changes	Material needed: Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre company funding, product support, employee authors and research roles separated?Required	The source records Morinaga Milk study support, manufacture and supply of MKP-containing hydrolysate and placebo tablets, four employee authors N.Y., M.T., K.Y. and F.A., and a supervision fee for N.S. The original limitation that separate public cofunding, medical-writing and publication support were not reported is retained. Design, analysis and data-control details are not newly established. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Four categories of Morinaga involvement and other support	Material needed: Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre null, positive secondary and unverified findings distinguished?Required	The null original total-score result, P=.302 and d=.12, is retained alongside the positive secondary Orientation P=.022, which does not overturn failure of the total score. Unverified details of CIs, plans and denominators differ from unread external material. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Total-score and subscale findings and material-access states	Material needed: Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionWere the paper and registration counted as separate clinical trials?Required	Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial. The same people, groups, visits, total scores, subscales, references, registration and related sheets are not added as new independent trials or participants. Two linked documents comprise one clinical paper and one registration record, not certified counts of unique trials or participants. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Report and registration linkage versus actual trials and participants	Material needed: Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionIs there separate independent confirmation?Supplementary	The original parent replication axis R1 and independence axis I0 are retained. The paper, registration, subscales in the same participants and related sheets are not certified as new independent replications. No separate replication of harm findings is created in this work. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Distinguish a single manufacturer trial from independent replication	Material needed: Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionAre subclaim grades distinguished from original parent scores and axes?Required	The selected record's grade, note and Korean and English question wording are retained; absent subclaim score, status and axes remain unrecorded. Parent D30, Good safety and B/P/R1/I0/E0/B0/C0 are parent context and are not transferred to the subclaim. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Subclaim grade, note and absences versus parent D30	Material needed: Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre both languages and absent structured fields preserved?Required	The parent Korean and English texts, evidence and citations, axes and original selected subclaim are retained in the full stored summary. Separate Korean and English classification fields are absent; no new fields are inserted into the original summary. No external comparison with the English paper was performed. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Korean and English originals and absent separate classification fields	Material needed: Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre the reference date, corrections and historical cross-checking separated from production?Required	The 2026-08-26 reference date, empty correction array and deliberation string, and historical cross-checking in the verdict-decision record are retained. The original date and history are not condition-freezing, application, production or completed-content-review dates. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original 2026-08-26 reference date and empty corrections	Material needed: When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionWhich direct material would fill the selected gaps?Supplementary	The primary total-score null finding and gaps in CIs and clinical thresholds are retained. Precision and clinical importance require direct comparative material for that total score; subscales cannot substitute. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Prespecified questions, direct effects, CIs, plans and follow-up	Material needed: Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionAre production, existing content review and practical instructions separated?Supplementary	This is an application-condition record based on the preserved summary. Existing content and question-boundary review are incomplete; historical candidate pending and eligibility labels are retained as history. Existing review status is recorded as it stands. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Production request, historical candidate record and responsibility for existing content review	Material needed: Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement. Only material requests and research needs are recorded; no retrieval or research is performed in this work.

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30 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 268 community-dwelling Japanese adults aged 40 or older without dementia; intention-to-treat analysis, 134/134. Completion, withdrawal and observed denominators for the selected endpoint are not verified in detail.
Ingredient, formulation and route: Casein hydrolysate tablets containing the casein-derived peptide Met-Lys-Pro (MKP)
Dose: Original study exposure only: MKP 200 μg/day for 24 weeks. No cumulative dose calculation or advice on consuming MKP, milk or products.
Comparator: Dextrin placebo tablets, 134 participants; sensory matching, blinding and concurrent exposures are not verified in detail.
Measured outcome: Primary ADAS-cog total score at 24 weeks, distinguished from Orientation, other tests and clinical function
Duration: 24 weeks; actual adherence, discontinuation, visit-specific follow-up and follow-up after the study are not verified in detail.
Questions outside this scope: Promoting positive Orientation findings into primary total-score success, improved global cognition, dementia prevention or clinical function; Copying group-specific total-score values, d, P or CI limitations into subscale results; Rejudging within-group improvement as an additional effect versus placebo, equivalence, noninferiority or a zero effect; Adding the same paper, registration, people, groups, visits, subscales or related sheets as new independent trials or participants; New calculations, hypothetical quantities, effects, CIs, grades or independence certification, or instructions on MKP, milk or product consumption, cognition or dementia care, or replacement of treatment

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Yuda N, et al. Effect of the Casein-Derived Peptide Met-Lys-Pro on Cognitive Function in Community-Dwelling Adults Without Dementia. Clin Interv Aging. 2020;15:743-754. PMID: 32546992.

PubMed

Material type: Double-blind randomized placebo-controlled parallel trial
Materials actually read: Stored summary read; external abstract, full text, registration and plans unread
Findings recorded in the stored summary: 4.08±2.17 to 3.18±1.88 versus 4.10±2.10 to 3.43±2.10; baseline-adjusted P=0.302, d=0.12; 95% CI not reported
Record level: Total-score summary in the preserved evidence list; Orientation is linked separately to its subclaim and the original counterview.
Study overlap and independent replication: Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial context. The same people, groups, visits, total score, subscales, references, registration and related sheets are not added as new independent trials or participants. R01, the paper, and R02, the registration, are documents linked by the same UMIN identifier, not certified counts of unique trials or participants or a certification of independence.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	A preserved local copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
External abstract	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
External full text	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
Original registration	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
Protocol/SAP	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.

R02 · UMIN Clinical Trials Registry. UMIN000032833.

Official source

Material type: Official registration record for the same trial; not a separate report of effects
Materials actually read: Stored summary read; external abstract, full text, registration and plans unread
Findings recorded in the stored summary: ADAS-Jcog was the prespecified primary endpoint, and public disclosure preceded the planned start.
Record level: Existing citation statement about registration plans; not a new clinical effect or result
Study overlap and independent replication: Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial context. The same people, groups, visits, total score, subscales, references, registration and related sheets are not added as new independent trials or participants. R01, the paper, and R02, the registration, are documents linked by the same UMIN identifier, not certified counts of unique trials or participants or a certification of independence.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	A preserved local copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
Original registration	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
registry_history	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
protocol	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
analysis_plan	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.

Report counts versus independent study counts

Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial context. The same people, groups, visits, total score, subscales, references, registration and related sheets are not added as new independent trials or participants. R01, the paper, and R02, the registration, are documents linked by the same UMIN identifier, not certified counts of unique trials or participants or a certification of independence.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which existing total-score claim is being presented?

Required materials and conditions: Separate the selected ADAS-cog total score and subclaim grade from parent values
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Separate the selected ADAS-cog total score and subclaim grade from parent values.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Separate the selected ADAS-cog total score and subclaim grade from parent values.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N02 · Which population's cognitive results are these?

Required materials and conditions: Community-dwelling adults without dementia and eligibility scope
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Community-dwelling adults without dementia and eligibility scope.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Community-dwelling adults without dementia and eligibility scope.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N03 · Are baseline scores distinguished from cognitive status?

Required materials and conditions: Baseline total scores and clinical diagnosis
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Baseline total scores and clinical diagnosis.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Baseline total scores and clinical diagnosis.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N04 · Is the study ingredient equivalent to ordinary milk?

Required materials and conditions: MKP and the casein-hydrolysate study product
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: MKP and the casein-hydrolysate study product.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: MKP and the casein-hydrolysate study product.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N05 · What were the control and group allocations?

Required materials and conditions: Dextrin placebo and actual control conditions
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Dextrin placebo and actual control conditions.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Dextrin placebo and actual control conditions.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N06 · Is 24-week study exposure distinguished from actual use and follow-up?

Required materials and conditions: Duration, adherence and persistence after the study
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Duration, adherence and persistence after the study.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Duration, adherence and persistence after the study.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N07 · Does ITT for 268 participants mean everyone completed follow-up?

Required materials and conditions: Allocation, analysis, completion, withdrawal and endpoint-specific denominators
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Allocation, analysis, completion, withdrawal and endpoint-specific denominators.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Allocation, analysis, completion, withdrawal and endpoint-specific denominators.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N08 · What do the original allocation and blinding statements say?

Required materials and conditions: Computer block allocation and multiple blinding roles
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Computer block allocation and multiple blinding roles.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Computer block allocation and multiple blinding roles.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N09 · Which primary test was the total score?

Required materials and conditions: ADAS-cog total score and the registered ADAS-Jcog name
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: ADAS-cog total score and the registered ADAS-Jcog name.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: ADAS-cog total score and the registered ADAS-Jcog name.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N10 · Are before-and-after total scores separated from the between-group comparison?

Required materials and conditions: Original total scores and baseline-adjusted effects
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Original total scores and baseline-adjusted effects.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Original total scores and baseline-adjusted effects.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N11 · What do the null total-score finding and small d limit?

Required materials and conditions: Original P and d and unverified CIs and clinical importance
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Original P and d and unverified CIs and clinical importance.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Original P and d and unverified CIs and clinical importance.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N12 · Were CIs and a prespecified clinical threshold reported?

Required materials and conditions: Effect precision and clinical thresholds
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Effect precision and clinical thresholds.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Effect precision and clinical thresholds.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N13 · Was improvement in both groups assigned to the ingredient?

Required materials and conditions: Repeat testing and additional effects versus placebo
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Repeat testing and additional effects versus placebo.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Repeat testing and additional effects versus placebo.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N14 · Does positive Orientation replace the failed total score?

Required materials and conditions: Separate the primary total score from the secondary subscale
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Separate the primary total score from the secondary subscale.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Separate the primary total score from the secondary subscale.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N15 · Are complete results for other subscales and tests available?

Required materials and conditions: Total score, individual subscales and other tests
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Total score, individual subscales and other tests.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Total score, individual subscales and other tests.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N16 · Were total-score findings extended to dementia prevention or daily function?

Required materials and conditions: Cognitive scores and clinical function or incidence outcomes
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Cognitive scores and clinical function or incidence outcomes.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Cognitive scores and clinical function or incidence outcomes.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N17 · Were endpoints, visits or related sheets counted as separate replications?

Required materials and conditions: Relationships between total scores and subscales in the same report and participants
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Relationships between total scores and subscales in the same report and participants.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Relationships between total scores and subscales in the same report and participants.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N18 · What is the scope of the original serious-adverse-event statement?

Required materials and conditions: Related SAEs over 24 weeks, other harms and allergy
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Related SAEs over 24 weeks, other harms and allergy.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Related SAEs over 24 weeks, other harms and allergy.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N19 · What materials were actually read in this work?

Required materials and conditions: Preserved-summary reading and external paper or registration status
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Preserved-summary reading and external paper or registration status.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Preserved-summary reading and external paper or registration status.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N20 · Are historical registration dates and primary-endpoint names distinguished from current reading?

Required materials and conditions: UMIN000032833 history and prespecified plans
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: UMIN000032833 history and prespecified plans.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: UMIN000032833 history and prespecified plans.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N21 · Were protocol, SAP, subscale and multiplicity plans acquired?

Required materials and conditions: Separate evidence for prespecified plans, analyses and changes
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Separate evidence for prespecified plans, analyses and changes.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Separate evidence for prespecified plans, analyses and changes.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N22 · Are company funding, product support, employee authors and research roles separated?

Required materials and conditions: Four categories of Morinaga involvement and other support
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Four categories of Morinaga involvement and other support.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Four categories of Morinaga involvement and other support.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N23 · Are null, positive secondary and unverified findings distinguished?

Required materials and conditions: Total-score and subscale findings and material-access states
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Total-score and subscale findings and material-access states.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Total-score and subscale findings and material-access states.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N24 · Were the paper and registration counted as separate clinical trials?

Required materials and conditions: Report and registration linkage versus actual trials and participants
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Report and registration linkage versus actual trials and participants.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Report and registration linkage versus actual trials and participants.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N25 · Is there separate independent confirmation?

Required materials and conditions: Distinguish a single manufacturer trial from independent replication
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Distinguish a single manufacturer trial from independent replication.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Distinguish a single manufacturer trial from independent replication.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N26 · Are subclaim grades distinguished from original parent scores and axes?

Required materials and conditions: Subclaim grade, note and absences versus parent D30
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Subclaim grade, note and absences versus parent D30.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Subclaim grade, note and absences versus parent D30.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N27 · Are both languages and absent structured fields preserved?

Required materials and conditions: Korean and English originals and absent separate classification fields
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Korean and English originals and absent separate classification fields.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Korean and English originals and absent separate classification fields.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N28 · Are the reference date, corrections and historical cross-checking separated from production?

Required materials and conditions: Original 2026-08-26 reference date and empty corrections
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Original 2026-08-26 reference date and empty corrections.
Requirement and applicability: Required
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Original 2026-08-26 reference date and empty corrections.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N29 · Which direct material would fill the selected gaps?

Required materials and conditions: Prespecified questions, direct effects, CIs, plans and follow-up
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Prespecified questions, direct effects, CIs, plans and follow-up.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Prespecified questions, direct effects, CIs, plans and follow-up.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N30 · Are production, existing content review and practical instructions separated?

Required materials and conditions: Production request, historical candidate record and responsibility for existing content review
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Production request, historical candidate record and responsibility for existing content review.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Production request, historical candidate record and responsibility for existing content review.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-15 · Public page/material version 1.0

The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which existing total-score claim is being presented?

Current findings: The selected wording is “Improved ADAS-cog total score”, with original subclaim grade D and a note that the baseline-adjusted result was null, P=0.302 and d=0.12. Absent subclaim score, status and axes are not filled with parent D30 values or axes.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: The selected total score's effect of interest, population, visit and review of the claim boundary. Original subclaim absences and parent context are retained separately.
Required materials and conditions: Separate the selected ADAS-cog total score and subclaim grade from parent values
Materials to obtain first: The selected total score's effect of interest, population, visit and review of the claim boundary. Original subclaim absences and parent context are retained separately.
Further research: Material needed: The selected total score's effect of interest, population, visit and review of the claim boundary. Original subclaim absences and parent context are retained separately. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Separate the selected ADAS-cog total score and subclaim grade from parent values.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Separate the selected ADAS-cog total score and subclaim grade from parent values.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N02 · Which population's cognitive results are these?

Current findings: The population comprised 268 community-dwelling Japanese adults aged 40 or older without dementia. Results are not extended to people with dementia, all cognitive impairment, or other ages or regions.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original eligibility and exclusion criteria, cognitive-status classification, baseline characteristics, comorbidities and medication, and direct comparisons in other populations.
Required materials and conditions: Community-dwelling adults without dementia and eligibility scope
Materials to obtain first: Original eligibility and exclusion criteria, cognitive-status classification, baseline characteristics, comorbidities and medication, and direct comparisons in other populations.
Further research: Material needed: Original eligibility and exclusion criteria, cognitive-status classification, baseline characteristics, comorbidities and medication, and direct comparisons in other populations. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Community-dwelling adults without dementia and eligibility scope.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Community-dwelling adults without dementia and eligibility scope.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N03 · Are baseline scores distinguished from cognitive status?

Current findings: Baseline total scores were MKP 4.08±2.17 and placebo 4.10±2.10. The absence of dementia and the scores are retained as separate information. These values are not used to newly establish normal cognition, MCI or dementia thresholds, or floor or ceiling effects.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original data on score range and direction, population-specific cognitive classification, distributions and baseline clinical function. No new score conversion or diagnosis.
Required materials and conditions: Baseline total scores and clinical diagnosis
Materials to obtain first: Original data on score range and direction, population-specific cognitive classification, distributions and baseline clinical function. No new score conversion or diagnosis.
Further research: Material needed: Original data on score range and direction, population-specific cognitive classification, distributions and baseline clinical function. No new score conversion or diagnosis. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Baseline total scores and clinical diagnosis.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Baseline total scores and clinical diagnosis.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N04 · Is the study ingredient equivalent to ordinary milk?

Current findings: The original intervention was milk-casein-derived Met-Lys-Pro (MKP), 200 μg/day; MKP-containing casein-hydrolysate tablets were manufactured and supplied. This is not converted into an amount or equivalence of ordinary milk or other casein products.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original tablet composition, MKP quantification and manufacturing, other ingredients, adherence and product identity. The original dose identifies study exposure and is not consumption or product advice.
Required materials and conditions: MKP and the casein-hydrolysate study product
Materials to obtain first: Original tablet composition, MKP quantification and manufacturing, other ingredients, adherence and product identity. The original dose identifies study exposure and is not consumption or product advice.
Further research: Material needed: Original tablet composition, MKP quantification and manufacturing, other ingredients, adherence and product identity. The original dose identifies study exposure and is not consumption or product advice. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: MKP and the casein-hydrolysate study product.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: MKP and the casein-hydrolysate study product.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N05 · What were the control and group allocations?

Current findings: 268 participants were allocated to MKP 200 μg/day or dextrin placebo, 134 in each group. The summary does not establish actual placebo-tablet details, sensory matching, blinding or concurrent exposures.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original placebo composition, tablet count and expectations, concurrent diet and medication, contact, adherence and allocation concealment. The same effect is not transferred to other controls.
Required materials and conditions: Dextrin placebo and actual control conditions
Materials to obtain first: Original placebo composition, tablet count and expectations, concurrent diet and medication, contact, adherence and allocation concealment. The same effect is not transferred to other controls.
Further research: Material needed: Original placebo composition, tablet count and expectations, concurrent diet and medication, contact, adherence and allocation concealment. The same effect is not transferred to other controls. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Dextrin placebo and actual control conditions.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Dextrin placebo and actual control conditions.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N06 · Is 24-week study exposure distinguished from actual use and follow-up?

Current findings: Original study exposure was 200 μg/day for 24 weeks. Actual exposure, adherence, discontinuation, visit-specific measurements and persistence after the study are not verified in detail. No new cumulative dose or number of days is calculated.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Group-specific actual exposure, adherence, discontinuation, measurement timing and poststudy follow-up. No long-term dementia-prevention or treatment instructions.
Required materials and conditions: Duration, adherence and persistence after the study
Materials to obtain first: Group-specific actual exposure, adherence, discontinuation, measurement timing and poststudy follow-up. No long-term dementia-prevention or treatment instructions.
Further research: Material needed: Group-specific actual exposure, adherence, discontinuation, measurement timing and poststudy follow-up. No long-term dementia-prevention or treatment instructions. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Duration, adherence and persistence after the study.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Duration, adherence and persistence after the study.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N07 · Does ITT for 268 participants mean everyone completed follow-up?

Current findings: The existing evidence list records 268 randomized participants and ITT analysis (134/134). ITT is not recast as completion of 24 weeks by everyone or identical observed denominators for all outcomes. Actual completion, withdrawal and missingness are not verified in detail.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Group-specific flow diagrams and reasons for completion or withdrawal, observed and analyzed denominators for total scores and visits, and missing-data handling. No new withdrawal count, rate or measurement total is calculated.
Required materials and conditions: Allocation, analysis, completion, withdrawal and endpoint-specific denominators
Materials to obtain first: Group-specific flow diagrams and reasons for completion or withdrawal, observed and analyzed denominators for total scores and visits, and missing-data handling. No new withdrawal count, rate or measurement total is calculated.
Further research: Material needed: Group-specific flow diagrams and reasons for completion or withdrawal, observed and analyzed denominators for total scores and visits, and missing-data handling. No new withdrawal count, rate or measurement total is calculated. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Allocation, analysis, completion, withdrawal and endpoint-specific denominators.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Allocation, analysis, completion, withdrawal and endpoint-specific denominators.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N08 · What do the original allocation and blinding statements say?

Current findings: The original Korean and English texts record computer block randomization, blinding of participants, physicians, assessors and analysts, and analysis by assigned group. The original design statement is retained; this is not a new comparison of procedures or data or an official RoB certification.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original allocation-concealment and blinding implementation or unblinding records, intervention deviations, missingness and analysis processes. Company involvement and design strengths remain separate.
Required materials and conditions: Computer block allocation and multiple blinding roles
Materials to obtain first: Original allocation-concealment and blinding implementation or unblinding records, intervention deviations, missingness and analysis processes. Company involvement and design strengths remain separate.
Further research: Material needed: Original allocation-concealment and blinding implementation or unblinding records, intervention deviations, missingness and analysis processes. Company involvement and design strengths remain separate. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Computer block allocation and multiple blinding roles.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Computer block allocation and multiple blinding roles.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N09 · Which primary test was the total score?

Current findings: The paper summary identifies the primary endpoint as ADAS-cog total score at 24 weeks. The preserved registration citation says ADAS-Jcog was the prespecified primary endpoint. No new external comparison of names, versions, exact measurement or hierarchy was performed.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Exact test version, total-score calculation and direction, measurement timing, and specifications in the paper, registration and protocol. Different names are not automatically treated as equivalent.
Required materials and conditions: ADAS-cog total score and the registered ADAS-Jcog name
Materials to obtain first: Exact test version, total-score calculation and direction, measurement timing, and specifications in the paper, registration and protocol. Different names are not automatically treated as equivalent.
Further research: Material needed: Exact test version, total-score calculation and direction, measurement timing, and specifications in the paper, registration and protocol. Different names are not automatically treated as equivalent. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: ADAS-cog total score and the registered ADAS-Jcog name.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: ADAS-cog total score and the registered ADAS-Jcog name.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N10 · Are before-and-after total scores separated from the between-group comparison?

Current findings: Total scores were MKP 4.08±2.17 to 3.18±1.88 and placebo 4.10±2.10 to 3.43±2.10. These are retained separately from the original baseline-adjusted between-group P=0.302 and d=0.12. No new difference, ratio or CI is calculated from before-and-after values.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Dispersion notation in the original table, group-specific analysis denominators, baseline-adjusted model, effect of interest and missing-data handling. The meaning of ± is not guessed.
Required materials and conditions: Original total scores and baseline-adjusted effects
Materials to obtain first: Dispersion notation in the original table, group-specific analysis denominators, baseline-adjusted model, effect of interest and missing-data handling. The meaning of ± is not guessed.
Further research: Material needed: Dispersion notation in the original table, group-specific analysis denominators, baseline-adjusted model, effect of interest and missing-data handling. The meaning of ± is not guessed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Original total scores and baseline-adjusted effects.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Original total scores and baseline-adjusted effects.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N11 · What do the null total-score finding and small d limit?

Current findings: The original baseline-adjusted total-score result, P=0.302 and d=0.12, was judged null. It is not rejudged as an exactly zero effect, equivalence, noninferiority or exclusion of a clinically important benefit.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Effect-estimate definition, 95% CI, prespecified externally validated clinical threshold, uncertainty and importance. No new effect, CI or hypothetical example.
Required materials and conditions: Original P and d and unverified CIs and clinical importance
Materials to obtain first: Effect-estimate definition, 95% CI, prespecified externally validated clinical threshold, uncertainty and importance. No new effect, CI or hypothetical example.
Further research: Material needed: Effect-estimate definition, 95% CI, prespecified externally validated clinical threshold, uncertainty and importance. No new effect, CI or hypothetical example. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Original P and d and unverified CIs and clinical importance.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Original P and d and unverified CIs and clinical importance.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N12 · Were CIs and a prespecified clinical threshold reported?

Current findings: The original material explains that a 95% CI for the primary endpoint and a prespecified externally validated clinical threshold were not reported, so a meaningful benefit could not be excluded. This original reporting limitation is not recast as a current rereading of the full paper.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original effect estimates and intervals, clinical-threshold setting, plans and analysis data, or separate confirmatory evidence. A sample size of 268 alone does not certify precision or exclusion of benefit.
Required materials and conditions: Effect precision and clinical thresholds
Materials to obtain first: Original effect estimates and intervals, clinical-threshold setting, plans and analysis data, or separate confirmatory evidence. A sample size of 268 alone does not certify precision or exclusion of benefit.
Further research: Material needed: Original effect estimates and intervals, clinical-threshold setting, plans and analysis data, or separate confirmatory evidence. A sample size of 268 alone does not certify precision or exclusion of benefit. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Effect precision and clinical thresholds.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Effect precision and clinical thresholds.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N13 · Was improvement in both groups assigned to the ingredient?

Current findings: The original reader answer and advertising interpretation attribute improvement in both groups to repeat testing and explain that it should not be assigned to a specific MKP effect. This retains the original interpretation, not a new mechanistic or causal verification.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original information on repeat testing, practice and expectations, within- and between-group analyses, effect of interest and concurrent exposures. No new product effect is calculated from within-group change.
Required materials and conditions: Repeat testing and additional effects versus placebo
Materials to obtain first: Original information on repeat testing, practice and expectations, within- and between-group analyses, effect of interest and concurrent exposures. No new product effect is calculated from within-group change.
Further research: Material needed: Original information on repeat testing, practice and expectations, within- and between-group analyses, effect of interest and concurrent exposures. No new product effect is calculated from within-group change. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Repeat testing and additional effects versus placebo.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Repeat testing and additional effects versus placebo.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N14 · Does positive Orientation replace the failed total score?

Current findings: The original statement is retained: Orientation P=0.022 is a disclosed secondary result but does not overturn the null primary total score. Total-score P, d, group values or CI limitations are not copied into Orientation results.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original subscale results, hierarchy, prespecified plans, multiple comparisons, individual effects and CIs, and separate confirmation. These are not promoted into total-score or global-cognition efficacy.
Required materials and conditions: Separate the primary total score from the secondary subscale
Materials to obtain first: Original subscale results, hierarchy, prespecified plans, multiple comparisons, individual effects and CIs, and separate confirmation. These are not promoted into total-score or global-cognition efficacy.
Further research: Material needed: Original subscale results, hierarchy, prespecified plans, multiple comparisons, individual effects and CIs, and separate confirmation. These are not promoted into total-score or global-cognition efficacy. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Separate the primary total score from the secondary subscale.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Separate the primary total score from the secondary subscale.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N15 · Are complete results for other subscales and tests available?

Current findings: The preserved material describes the total score and Orientation. Other subscales and tests, the total number of tests, complete results and the multiplicity plan are not verified in detail. No new list or count of positive or null results is created.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Complete result tables, measurement tools, registration, protocol, SAP, and testing or selective-reporting plans. Unread external material is not assumed to be unreported.
Required materials and conditions: Total score, individual subscales and other tests
Materials to obtain first: Complete result tables, measurement tools, registration, protocol, SAP, and testing or selective-reporting plans. Unread external material is not assumed to be unreported.
Further research: Material needed: Complete result tables, measurement tools, registration, protocol, SAP, and testing or selective-reporting plans. Unread external material is not assumed to be unreported. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Total score, individual subscales and other tests.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Total score, individual subscales and other tests.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N16 · Were total-score findings extended to dementia prevention or daily function?

Current findings: The original population was adults without dementia and the primary endpoint was ADAS-cog total score at 24 weeks. The preserved scope provides no separate direct results for dementia incidence, daily function or replacement of treatment. These are not established from total scores or subscale signals.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Definitions, duration, group-specific denominators, effects and CIs for clinical function or dementia events actually measured, and direct longer-term follow-up. Unread material is not assumed to mean the outcome was not measured.
Required materials and conditions: Cognitive scores and clinical function or incidence outcomes
Materials to obtain first: Definitions, duration, group-specific denominators, effects and CIs for clinical function or dementia events actually measured, and direct longer-term follow-up. Unread material is not assumed to mean the outcome was not measured.
Further research: Material needed: Definitions, duration, group-specific denominators, effects and CIs for clinical function or dementia events actually measured, and direct longer-term follow-up. Unread material is not assumed to mean the outcome was not measured. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Cognitive scores and clinical function or incidence outcomes.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Cognitive scores and clinical function or incidence outcomes.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N17 · Were endpoints, visits or related sheets counted as separate replications?

Current findings: Total score and Orientation are different outcomes from the same Yuda2020 report and 268-person, 24-week trial. The same people, groups, visits, subscales, registration and related sheets are not added as new independent trials or participants.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original analysis, registration and report identities and links between repeated measurements and cohorts. Document counts are distinguished from certified counts of unique trials or participants.
Required materials and conditions: Relationships between total scores and subscales in the same report and participants
Materials to obtain first: Original analysis, registration and report identities and links between repeated measurements and cohorts. Document counts are distinguished from certified counts of unique trials or participants.
Further research: Material needed: Original analysis, registration and report identities and links between repeated measurements and cohorts. Document counts are distinguished from certified counts of unique trials or participants. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Relationships between total scores and subscales in the same report and participants.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Relationships between total scores and subscales in the same report and participants.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N18 · What is the scope of the original serious-adverse-event statement?

Current findings: The original safety explanation states that no serious adverse event attributed to MKP was reported over 24 weeks and includes a milk-protein-allergy caution. The full preserved summary is retained; this is not extended to zero adverse events, long-term safety or safety in all populations.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Group-specific AE and SAE collection methods, exposure and denominators, discontinuation, attribution, allergy populations and longer-term harms. No new product-consumption or treatment guidance.
Required materials and conditions: Related SAEs over 24 weeks, other harms and allergy
Materials to obtain first: Group-specific AE and SAE collection methods, exposure and denominators, discontinuation, attribution, allergy populations and longer-term harms. No new product-consumption or treatment guidance.
Further research: Material needed: Group-specific AE and SAE collection methods, exposure and denominators, discontinuation, attribution, allergy populations and longer-term harms. No new product-consumption or treatment guidance. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Related SAEs over 24 weeks, other harms and allergy.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Related SAEs over 24 weeks, other harms and allergy.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N19 · What materials were actually read in this work?

Current findings: The complete parent summary was read for production and preserved in its original form. Summary reading refers to the stored summary; the external abstract, full paper, UMIN registration, protocol and SAP remain unread in this work. The existence of a URL is not promoted into reading.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed.
Required materials and conditions: Preserved-summary reading and external paper or registration status
Materials to obtain first: Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed.
Further research: Material needed: Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Preserved-summary reading and external paper or registration status.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Preserved-summary reading and external paper or registration status.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N20 · Are historical registration dates and primary-endpoint names distinguished from current reading?

Current findings: The original Korean and English texts describe prospective registration, with disclosure on 2018-06-04 and a planned start on 2018-06-07. The registration citation describes prespecified ADAS-Jcog and manufacturer funding. Only original dates and statements are retained; actual start, versions and plan agreement are not newly verified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it.
Required materials and conditions: UMIN000032833 history and prespecified plans
Materials to obtain first: Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it.
Further research: Material needed: Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: UMIN000032833 history and prespecified plans.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: UMIN000032833 history and prespecified plans.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N21 · Were protocol, SAP, subscale and multiplicity plans acquired?

Current findings: Original registration and historical cross-checking statements are retained. The original protocol and SAP, versions and dates, subscale and multiplicity plans, and clinical thresholds have not been read in this work. A registration statement about the primary endpoint does not establish all secondary plans.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent.
Required materials and conditions: Separate evidence for prespecified plans, analyses and changes
Materials to obtain first: Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent.
Further research: Material needed: Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Separate evidence for prespecified plans, analyses and changes.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Separate evidence for prespecified plans, analyses and changes.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N22 · Are company funding, product support, employee authors and research roles separated?

Current findings: The source records Morinaga Milk study support, manufacture and supply of MKP-containing hydrolysate and placebo tablets, four employee authors N.Y., M.T., K.Y. and F.A., and a supervision fee for N.S. The original limitation that separate public cofunding, medical-writing and publication support were not reported is retained. Design, analysis and data-control details are not newly established.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work.
Required materials and conditions: Four categories of Morinaga involvement and other support
Materials to obtain first: Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work.
Further research: Material needed: Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Four categories of Morinaga involvement and other support.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Four categories of Morinaga involvement and other support.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N23 · Are null, positive secondary and unverified findings distinguished?

Current findings: The null original total-score result, P=.302 and d=.12, is retained alongside the positive secondary Orientation P=.022, which does not overturn failure of the total score. Unverified details of CIs, plans and denominators differ from unread external material.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported.
Required materials and conditions: Total-score and subscale findings and material-access states
Materials to obtain first: Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported.
Further research: Material needed: Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Total-score and subscale findings and material-access states.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Total-score and subscale findings and material-access states.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N24 · Were the paper and registration counted as separate clinical trials?

Current findings: Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial. The same people, groups, visits, total scores, subscales, references, registration and related sheets are not added as new independent trials or participants. Two linked documents comprise one clinical paper and one registration record, not certified counts of unique trials or participants.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded.
Required materials and conditions: Report and registration linkage versus actual trials and participants
Materials to obtain first: Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded.
Further research: Material needed: Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Report and registration linkage versus actual trials and participants.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Report and registration linkage versus actual trials and participants.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N25 · Is there separate independent confirmation?

Current findings: The original parent replication axis R1 and independence axis I0 are retained. The paper, registration, subscales in the same participants and related sheets are not certified as new independent replications. No separate replication of harm findings is created in this work.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict.
Required materials and conditions: Distinguish a single manufacturer trial from independent replication
Materials to obtain first: Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict.
Further research: Material needed: Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Distinguish a single manufacturer trial from independent replication.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Distinguish a single manufacturer trial from independent replication.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N26 · Are subclaim grades distinguished from original parent scores and axes?

Current findings: The selected record's grade, note and Korean and English question wording are retained; absent subclaim score, status and axes remain unrecorded. Parent D30, Good safety and B/P/R1/I0/E0/B0/C0 are parent context and are not transferred to the subclaim.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification.
Required materials and conditions: Subclaim grade, note and absences versus parent D30
Materials to obtain first: Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification.
Further research: Material needed: Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Subclaim grade, note and absences versus parent D30.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Subclaim grade, note and absences versus parent D30.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N27 · Are both languages and absent structured fields preserved?

Current findings: The parent Korean and English texts, evidence and citations, axes and original selected subclaim are retained in the full stored summary. Separate Korean and English classification fields are absent; no new fields are inserted into the original summary. No external comparison with the English paper was performed.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record.
Required materials and conditions: Korean and English originals and absent separate classification fields
Materials to obtain first: Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record.
Further research: Material needed: Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Korean and English originals and absent separate classification fields.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Korean and English originals and absent separate classification fields.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N28 · Are the reference date, corrections and historical cross-checking separated from production?

Current findings: The 2026-08-26 reference date, empty correction array and deliberation string, and historical cross-checking in the verdict-decision record are retained. The original date and history are not condition-freezing, application, production or completed-content-review dates.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review.
Required materials and conditions: Original 2026-08-26 reference date and empty corrections
Materials to obtain first: When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review.
Further research: Material needed: When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Original 2026-08-26 reference date and empty corrections.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Original 2026-08-26 reference date and empty corrections.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N29 · Which direct material would fill the selected gaps?

Current findings: The primary total-score null finding and gaps in CIs and clinical thresholds are retained. Precision and clinical importance require direct comparative material for that total score; subscales cannot substitute.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed.
Required materials and conditions: Prespecified questions, direct effects, CIs, plans and follow-up
Materials to obtain first: Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed.
Further research: Material needed: Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Prespecified questions, direct effects, CIs, plans and follow-up.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Prespecified questions, direct effects, CIs, plans and follow-up.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N30 · Are production, existing content review and practical instructions separated?

Current findings: This is an application-condition record based on the preserved summary. Existing content and question-boundary review are incomplete; historical candidate pending and eligibility labels are retained as history. Existing review status is recorded as it stands.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement.
Required materials and conditions: Production request, historical candidate record and responsibility for existing content review
Materials to obtain first: Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement.
Further research: Material needed: Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Production request, historical candidate record and responsibility for existing content review.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Production request, historical candidate record and responsibility for existing content review.
Application exceptions: Distinguish the primary total-score null finding, group-specific before-and-after values, baseline-adjusted P and d, gaps in CIs and clinical thresholds, subscale signals, multiplicity, baseline cognition, population, intervention, control, exposure, duration, ITT, withdrawal, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01