{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2980-s0", "verdict_number": "2980", "title": "Casein-derived MKP × ADAS-cog total score: Primary null finding and gaps in CIs and clinical thresholds", "view_version": "1.0", "view_created_date": "2026-10-15", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which existing total-score claim is being presented?", "needed": "Separate the selected ADAS-cog total score and subclaim grade from parent values", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which population's cognitive results are these?", "needed": "Community-dwelling adults without dementia and eligibility scope", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original eligibility and exclusion criteria, cognitive-status classification, baseline characteristics, comorbidities and medication, and direct comparisons in other populations.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original eligibility and exclusion criteria, cognitive-status classification, baseline characteristics, comorbidities and medication, and direct comparisons in other populations." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are baseline scores distinguished from cognitive status?", "needed": "Baseline total scores and clinical diagnosis", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original data on score range and direction, population-specific cognitive classification, distributions and baseline clinical function. No new score conversion or diagnosis.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original data on score range and direction, population-specific cognitive classification, distributions and baseline clinical function. No new score conversion or diagnosis." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Is the study ingredient equivalent to ordinary milk?", "needed": "MKP and the casein-hydrolysate study product", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What were the control and group allocations?", "needed": "Dextrin placebo and actual control conditions", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Is 24-week study exposure distinguished from actual use and follow-up?", "needed": "Duration, adherence and persistence after the study", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Group-specific actual exposure, adherence, discontinuation, measurement timing and poststudy follow-up. No long-term dementia-prevention or treatment instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific actual exposure, adherence, discontinuation, measurement timing and poststudy follow-up. No long-term dementia-prevention or treatment instructions." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Does ITT for 268 participants mean everyone completed follow-up?", "needed": "Allocation, analysis, completion, withdrawal and endpoint-specific denominators", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What do the original allocation and blinding statements say?", "needed": "Computer block allocation and multiple blinding roles", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original allocation-concealment and blinding implementation or unblinding records, intervention deviations, missingness and analysis processes. Company involvement and design strengths remain separate.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation-concealment and blinding implementation or unblinding records, intervention deviations, missingness and analysis processes. Company involvement and design strengths remain separate." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which primary test was the total score?", "needed": "ADAS-cog total score and the registered ADAS-Jcog name", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are before-and-after total scores separated from the between-group comparison?", "needed": "Original total scores and baseline-adjusted effects", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What do the null total-score finding and small d limit?", "needed": "Original P and d and unverified CIs and clinical importance", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Effect-estimate definition, 95% CI, prespecified externally validated clinical threshold, uncertainty and importance. No new effect, CI or hypothetical example.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Effect-estimate definition, 95% CI, prespecified externally validated clinical threshold, uncertainty and importance. No new effect, CI or hypothetical example." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Were CIs and a prespecified clinical threshold reported?", "needed": "Effect precision and clinical thresholds", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Was improvement in both groups assigned to the ingredient?", "needed": "Repeat testing and additional effects versus placebo", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Does positive Orientation replace the failed total score?", "needed": "Separate the primary total score from the secondary subscale", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are complete results for other subscales and tests available?", "needed": "Total score, individual subscales and other tests", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Complete result tables, measurement tools, registration, protocol, SAP, and testing or selective-reporting plans. Unread external material is not assumed to be unreported.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete result tables, measurement tools, registration, protocol, SAP, and testing or selective-reporting plans. Unread external material is not assumed to be unreported." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Were total-score findings extended to dementia prevention or daily function?", "needed": "Cognitive scores and clinical function or incidence outcomes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Were endpoints, visits or related sheets counted as separate replications?", "needed": "Relationships between total scores and subscales in the same report and participants", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N18", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What is the scope of the original serious-adverse-event statement?", "needed": "Related SAEs over 24 weeks, other harms and allergy", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What materials were actually read in this work?", "needed": "Preserved-summary reading and external paper or registration status", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are historical registration dates and primary-endpoint names distinguished from current reading?", "needed": "UMIN000032833 history and prespecified plans", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Were protocol, SAP, subscale and multiplicity plans acquired?", "needed": "Separate evidence for prespecified plans, analyses and changes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are company funding, product support, employee authors and research roles separated?", "needed": "Four categories of Morinaga involvement and other support", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are null, positive secondary and unverified findings distinguished?", "needed": "Total-score and subscale findings and material-access states", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Were the paper and registration counted as separate clinical trials?", "needed": "Report and registration linkage versus actual trials and participants", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Is there separate independent confirmation?", "needed": "Distinguish a single manufacturer trial from independent replication", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are subclaim grades distinguished from original parent scores and axes?", "needed": "Subclaim grade, note and absences versus parent D30", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are both languages and absent structured fields preserved?", "needed": "Korean and English originals and absent separate classification fields", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are the reference date, corrections and historical cross-checking separated from production?", "needed": "Original 2026-08-26 reference date and empty corrections", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Which direct material would fill the selected gaps?", "needed": "Prespecified questions, direct effects, CIs, plans and follow-up", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are production, existing content review and practical instructions separated?", "needed": "Production request, historical candidate record and responsibility for existing content review", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." } ], "reports": [ { "report_id": "R01", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/32546992/", "report_type": "Double-blind randomized placebo-controlled parallel trial", "existence": "The existing citation contains the paper reference; external public availability and access are unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration and plans unread", "study_family": "F01", "independent_replication": "Provisional linkage of the same paper and registration; no certification of a separate independent trial or replicated efficacy", "observed_result": "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", "result_level": "Total-score summary in the preserved evidence list; Orientation is linked separately to its subclaim and the original counterview.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "A preserved local copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External abstract", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External full text", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Original registration", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Protocol/SAP", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/32546992/" } ] }, { "report_id": "R02", "title": "UMIN Clinical Trials Registry. UMIN000032833.", "url": "https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037442", "report_type": "Official registration record for the same trial; not a separate report of effects", "existence": "The existing citation contains the registration reference; external public availability and access are unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration and plans unread", "study_family": "F01", "independent_replication": "Provisional linkage of the same paper and registration; no certification of a separate independent trial or replicated efficacy", "observed_result": "ADAS-Jcog was the prespecified primary endpoint, and public disclosure preceded the planned start.", "result_level": "Existing citation statement about registration plans; not a new clinical effect or result", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "A preserved local copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Original registration", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "registry_history", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "protocol", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "analysis_plan", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." } ], "links": [ { "label": "Official source", "url": "https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037442" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "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" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-15", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-15" }