TASK-1039 / R01-079 — Oral sole-added biotin and cognitive function in adults with diagnosed mild cognitive impairment
research showsNo directly eligible between-group cognitive effect was verified. Neither magnitude, direction nor absence can be established.
ads claimMechanistic or dietary claims for biotin/B-vitamin combinations do not establish MCI treatment benefit.
Four separate assessment dimensions
| Effect direction and size | No directly eligible between-group cognitive effect was verified. Neither magnitude, direction nor absence can be established. |
|---|---|
| Evidence certainty | Certainty for the direct effect was not quantified. Related human data are separated from directly eligible evidence. |
| Applicability | Only diagnosed adult MCI and oral sole-added biotin are assessed. No extrapolation from AD, healthy participants, MS, deficiency correction, diet or combinations. |
| Safety | Caution. Susceptible immunoassay interference and unverified high-dose, long-term and special-population safety are described separately. |
Final grade null and score null. Raw C was rejected after three axis-validation errors; previous values from 3153/3154 were not copied.
Useful facts when choosing a product
- This assessment does not certify the quality or authorization of a marketed product.
- The question concerns oral biotin as the sole additional active ingredient.
- The molecular form, active content, dose and excipients of an eligible product remain unverified.
- A research regimen is not a personal dosing recommendation.
Chamgap Semantic Classification Code
Permanent code issued
S.biotin-sole-added-active-mci.oral.adult-diagnosed-mci.defined-time-instrument-specific-cognition.oral-biotin-mci-actual-comparator-unverifiedSupplements and nutraceuticals > Biotin > Question: adults with diagnosed MCI; actual diagnostic criteria, subtype, deficiency and kidney function unverified > Question: validated cognitive-scale difference at a defined time; actual instrument, language and timing unverified > Unverified: actual control, common care and placebo excipients > Question: oral; actual route in a directly eligible study unverified
Original null/unscored state, three failed axes, unverified actual conditions and full bilingual reports preserved. The code identifies the intervention and claim; it never contains the evidence grade, score, or safety result.
Exact Claim Classification
These independent facets prevent evidence from different forms, routes, populations, effects, and comparators from being mixed.
| Intervention class | S · Supplement or nutraceutical |
|---|---|
| Canonical ingredient or intervention | Biotin |
| Source or part used | Nutrient; actual manufacturing source and raw-material origin unverified |
| Formulation or processing | Question: oral sole-added active ingredient; actual molecular form, formulation and active content unverified |
| Route | Question: oral; actual route in a directly eligible study unverified |
| Dose | Unverified: no actual eligible dose or total intake |
| Duration | Unverified: no actual eligible treatment/follow-up duration |
| Population | Question: adults with diagnosed MCI; actual diagnostic criteria, subtype, deficiency and kidney function unverified |
| Effect or condition | Between-group cognitive-performance difference attributable to added biotin alone |
| Primary endpoint | Question: validated cognitive-scale difference at a defined time; actual instrument, language and timing unverified |
| Comparator | Unverified: actual control, common care and placebo excipients |
| Duplicate-detection key | R01|biotin|oral|COG|adults with diagnosed MCI |
What the research actually shows
# TASK-1039 / R01-079 — Oral sole-added biotin and cognitive function in adults with diagnosed mild cognitive impairment
Evidence/input cutoff: **2026-09-17T15:49:43+09:00**. Actual search and self-review date: **2026-09-17**. This is the first and only completed task in the current chat. New site identity, URL and first-publication date remain unassigned.
## 1. Thirty-second answer
Within the sources and searches accessible in this review, **no directly eligible estimate was verified for oral biotin as the sole additional active ingredient in clinically diagnosed adult mild cognitive impairment (MCI), compared with an actual control on a validated cognitive scale at a defined time.** The presence, size or absence of a benefit therefore cannot be determined numerically. This is not a claim of no human research, zero effect, equivalence or established safety.
Related human evidence exists. A 2026 multimodal case series mixed MCI with Alzheimer disease (AD) and combined supplements with lifestyle interventions. Dietary cohorts examined food-derived biotin and incident dementia. These designs do not isolate the cognitive effect of the added ingredient in this question. [S01–S04]
**Efficacy grade and score: explicitly unscored (null/null). Safety label: Caution.** The original calculator's invalid raw C was not adopted. Document quality A is a self-assessment of traceability, scope, limitations and bilingual completeness, not an efficacy A or external certification.
## 2. Fixed question versus observed facts
| Item | Boundary of this question | Value verified in a directly eligible study | |---|---|---| | Intervention | Oral biotin as the sole additional active ingredient | Not verified; molecular form, product, formulation, active content and actual administration are null | | Source and molecular identity | Biotin nutrient; source material, purity and isomer/salt must be checked per study | Unverified. Search synonyms vitamin B7/H and d-biotin do not guarantee product equivalence | | Population | Adults with a clinical MCI diagnosis | Directly eligible diagnosis, subtype, baseline cognition, age, education, deficiency, diet and kidney function are unverified | | Comparator | An actual placebo, usual-care or suitable active-control comparison | Actual comparator, common care and placebo excipients are null; proposed options are not facts | | Outcome | Between-group cognitive-performance difference at a defined time, separated by instrument | Actual instrument, language version, time, estimate, variance, CI and MCID are null | | Dose and duration | Actual exposure and duration extracted per study | A protocol range or a typical regimen is not substituted for observed dosing |
An MCI label or low screening score alone was not automatically accepted as a confirmed clinical diagnosis. Amnestic/nonamnestic and single-/multiple-domain subtypes, cause, severity and mixing with AD remain separate questions. Healthy participants, subjective memory complaints alone, dementia, depression/delirium, multiple sclerosis, congenital metabolic conditions and deficiency correction are different populations or claims. Unverified exclusion or diagnostic procedures remain unverified.
Sole additional active ingredient does not require a biotin-only treatment arm in every possible design. **Adding biotin versus a matched control on identical common background care** can isolate the incremental ingredient effect when those conditions are verified. Simultaneously changing other active ingredients or lifestyle interventions cannot. Food/diet associations, injections/topical products, animal mechanisms and blood markers were not substituted for oral biotin's MCI cognitive effect.
## 3. Full index and duplicate boundary
All **3,154 index records** were scanned for Korean/English biotin and molecular synonyms and neighboring MCI claims. All nine supplied biotin candidate originals were fully byte-read, UTF-8 decoded and parsed. Missing legacy fields were not inferred. Neighboring MCI index entries were read, but unsupplied full originals were not represented as accessed.
| Existing ID | Previous boundary | Difference from this question / reuse | |---|---|---| | 009 | Hair growth and hair loss | Hair outcomes; extraction and search map reused only | | 866 | Brittle-nail thickness and firmness | Nail outcomes; no universal prohibition inferred for a valid common-background add-on design | | 1639 | High-dose MD1003 in progressive MS, disability and walking | EDSS/T25FW are not MCI cognition; a cognition category tag is not a matching diagnosis | | 3103 | Hair density in adult androgenetic alopecia | Different population and outcome | | 3104 | Recurrent breakage events in brittle nails | Nail events, not cognition | | 3105 | HbA1c in type 2 diabetes | Glycemic surrogate separated from cognitive performance | | 3106 | Susceptible TSH assay interference after oral biotin | Safety map reused; not efficacy evidence | | 3153 | Atopic-dermatitis severity | Different disease outcome; previous unscored status not imported | | 3154 | Pain in painful diabetic peripheral neuropathy | NRS pain is separate from cognition; previous policy/data gaps not copied |
The decision is **operation=new**, with no exact duplicate found. These are nine reuse/boundary IDs, not nine efficacy trials. Original records, grades and public URLs remain unchanged. Original `what_research` and `what_research_original` strings are separately preserved. Exact provenance is in `duplicate_boundary.json` and `reuse/what_research_originals.json`.
## 4. Professional evidence table — no comparison accepted as direct efficacy
| Source | Design, denominator and time | Outcome and result | Exclusion or role | |---|---|---|---| | S01 · Kogan et al., 2026 | Retrospective uncontrolled multimodal case series 51 enrolled; 22 retained for at least 2.5 years; 29 discontinued in year one. MCI/AD-specific and actual biotin-exposure denominators were not reported. | MoCA in retained participants; other cognitive tests, imaging and blood markers are separate. Mean 21.7 to 22.5 is an uncontrolled within-group change, not an isolated between-group biotin effect. | Excluded from direct efficacy: multiple interventions, mixed diagnoses and no comparator. Used only as related human evidence and a boundary warning. | | S02 · Kim et al., 2018 | Dietary intake and cognition association in Koreans aged at least 50; first page only Total and analyzed denominators were not verified from the accessed first page. | CNS Vital Signs domains and EEG theta, not a MoCA treatment effect. Lower intake of biotin and several other nutrients in the group labeled MCI. Full diagnostic and adjusted-estimate details were inaccessible. | Excluded: dietary association rather than the incremental effect of oral biotin alone. | | S03 · Kong et al., 2025 | Prospective UK Biobank dietary cohort 122,959 participants; 1,256 incident dementia cases; median follow-up 11.25 years. | Incident dementia hazard by dietary intake, not a cognitive-scale difference in diagnosed MCI. Top versus bottom quartile HR 0.67, 95% CI 0.56–0.81, for all-cause dementia is an observational association. | Excluded: dietary exposure and prevention events. Not a treatment effect with residual confounding or reverse causation ruled out. | | S04 · Zhang et al., 2026 | UK Biobank dietary/brain-structure observations plus separate animal experiments No question-matched arm denominator in the accessed material; the original cohort total is not substituted. | Dementia events/brain structure and separate mouse behavior/amyloid endpoints. Human dietary associations and animal findings are not combined into an isolated biotin MCI cognitive effect. | Excluded: intervention, population and endpoint mismatch. Possible overlap with S03 is not independent treatment replication. | | S05 · de Jager et al., VITACOG, 2012 | Randomized double-blind placebo-controlled MCI trial of folate/B12/B6 133 versus 133 participants aged at least 70; two years. | Cognitive outcomes are secondary; MMSE, CLOX, HVLT and fluency remain separate. Favorable findings for some outcomes or higher-homocysteine subgroups are not biotin results. | Excluded: folate/B12/B6, not biotin. Other publications from the same VITACOG cohort are not new replications. | | S06 · Kwok et al., 2020 | Randomized MCI trial of methylcobalamin/folic acid versus placebo 279 participants aged at least 65; 24 months. | Primary CDR sum of boxes; secondary global CDR, memory/executive Z scores and depression. No significant 24-month group difference was reported; intermediate within-group changes are not sustained between-group benefit. | Excluded: a non-biotin combination. Its nonsignificant result is not evidence that biotin is ineffective. | | S07 · Aisen et al., 2008 | Randomized Alzheimer-disease trial of folate/B6/B12 versus placebo 409 participants: 240 active and 169 placebo; 18 months. | Primary ADAS-cog, 0–70 points with higher scores worse; baseline MMSE 14–26. Lack of benefit on the primary rate comparison belongs to a different disease and intervention. | Excluded: AD rather than MCI and no biotin. Failures in other indications are not repeated refutations of this claim. | | S08 · NIH ODS biotin professional fact sheet | Official nutrient and safety document No efficacy-trial sample or arm denominator applies. | Nutrient status, assay interference and limitations of high-dose safety evidence. No established upper limit does not confirm all high-dose or long-term use is safe; susceptible assays can be biased in either direction. | Reused safety and nutrient context, not an MCI efficacy trial. | | S09 · FDA biotin/troponin interference notice | Official regulatory safety information No cognitive-efficacy denominator applies. | Falsely low results in susceptible troponin assays. This does not imply the same effect on every platform or an event in every user. | Supports a caution label, separate from cognitive efficacy. |
## 5. Verification of the closest human report containing biotin
All six PDF pages, tables and appendix of S01 were inspected. Participants had clinical MCI or AD, but diagnosis-specific counts and subtypes were not consistently available. Appendix A's **d-biotin 1–5 mg/day is a typical supplement range**, not proof that all 51 people received biotin or that individual doses were verified. Diet, exercise, cognitive training, sleep/hormonal management and other supplements were combined, so the added biotin effect cannot be isolated. [S01, Methods and Appendix A]
Only 22 of 51 participants remained for at least 2.5 years; 29 discontinued within the first 12 months. Subtracting rounded retained-group MoCA means, 21.7 to 22.5, gives **+0.8 points**, an uncontrolled descriptive within-group difference. Improved 7, unchanged 9 and progressed 6 sum to 22; 16/22=72.727…% is improvement or stability among retained participants, not success in all 51. Attrition was 29/51=56.863…%, with outcomes unavailable in discontinuers. [S01, Table 1 and Results; arithmetic receipt]
The article describes MoCA as prespecified, but a registry primary outcome was not independently checked. The text describes a 2.5-year mean while the table presents variable latest follow-up; these were not reconstructed into a single fixed-visit comparison. Language/alternate forms, practice-effect adjustment and assessor masking for repeated six-month MoCA assessments were unverified. The authors' +2-point response criterion is not treated as a validated MCI MCID. Ranges were not converted into SD, rounded group means into patient data, or a comparative CI invented. [S01, Methods and Table 1]
Four patients were previously published, not independent replications. No reported financial support and disclosed app/clinic ownership/advisory interests are both preserved. Discontinuation was not presumed to be an adverse event; biotin-specific adverse-event exposure denominators were unavailable. These case-series limitations were not transplanted into the grading axes of a hypothetical directly eligible trial. [S01, Methods, Funding and Conflicts]
## 6. Favorable findings, contrary results and prohibited extrapolations
S02 concerns dietary intake and cognitive domains; only the first page was accessed. Detailed MCI classification, actual total intake, adjusted estimates, denominators and full-paper funding were not verified. It was not converted into a trial treating confirmed biochemical deficiency. [S02]
S03's dietary-quartile HR is an observational incident-dementia hazard ratio. It was not translated into improved MCI cognitive scores from supplementation or a drug-like 33% risk reduction. Human dietary/brain-structure findings and mouse deficiency/amyloid experiments in S04 remain separated by species and outcome. Both studies use UK Biobank; unverified overlap was not counted as independent treatment replication. [S03–S04]
Favorable secondary or subgroup findings in S05's MCI B-vitamin trial concern folate/B12/B6. The lack of significant benefit in parts of S06's B12/folate MCI trial and S07's AD B-vitamin trial likewise does not establish repeated biotin failure. Positive/negative findings from other ingredients, registered primary/secondary outcomes, post hoc analyses and multiplicity were not pooled into a vote on biotin. An article-reported registration number is distinguished from a registry record actually accessed here. [S05–S07]
S07 reported public NIA/NIH support and donated vitamins from Roche. Depression-related adverse events occurred in 67/240 active versus 30/169 placebo participants, without multiplicity adjustment. This is a safety observation from an 18-month AD folate/B6/B12 trial, not a biotin-related MCI harm estimate. [S07, Funding/Support and Adverse Events/Table 3]
## 7. Instruments, denominators, statistics and actual unknowns
| Outcome family | Adjacent evidence inspected | Status of the direct effect | |---|---|---| | MoCA | Higher scores are better in S01; retained-group descriptive change | Between-group difference, SE/CI, language version and MCID null | | MMSE | Cognitive outcome in S05; baseline AD range in S07 | Not combined with or converted to MoCA; direct effect null | | ADAS-cog | S07's 0–70 scale, with higher scores worse | Opposite directions not pooled without definition; direct effect null | | Memory, executive function and fluency | CNS Vital Signs, CLOX, HVLT and domain Z scores are different tests | Actual units, direction and language must be verified per test; not merged with global cognition | | Function and clinical severity | CDR sum of boxes and clinical functional notes | Separate from a cognitive-performance score | | Dementia conversion/incidence | UK Biobank event HR | Separate from change in people already diagnosed with MCI | | Imaging, blood markers and EEG | MRI, amyloid/tau and EEG | Biomarkers are not substituted for clinical cognitive benefit | | Subjective memory | No eligible direct result verified | Not a substitute for validated performance testing or MCI diagnosis |
Actual directly eligible molecular form, formulation, purity, active content, dose, frequency, total dietary-plus-supplement intake, duration, adherence, deficiency assessment, kidney function, diet, baseline cognition, common/rescue care, comparator and placebo excipients are recorded as null with reasons in `scope_and_extraction.json`. No specific marketed product, composition or individual safety was certified.
The same applies to randomized/analyzed/completed/withdrawn denominators, ITT/completer populations, missing-data methods, randomization/concealment/masking, crossover/paired/cluster design and washout, timing/baseline adjustment/practice effects, within-group/between-group/adjusted estimates, SD/SE/CI, MCID/response criteria, registered primary/secondary/post hoc outcomes, multiplicity, cohort overlap, funding/product provision/conflicts and arm-specific safety exposure. Unknown does not mean no defect or zero events. Without direct comparative data and suitable variance, no meta-analysis, SMD, ARR/NNT or assumed-control calculation was performed. [Extraction file; S01–S07 access limits]
## 8. Safety — Caution label, separate detail
Biotin can distort some susceptible immunoassays toward falsely high or low results; FDA warns about falsely low results with certain troponin assays. This is not a claim that every platform is equally affected. Actual supplement name, strength and last-use information should be communicated to the clinical/laboratory team. No universal pre-test interruption interval or personal medication stopping/restarting instruction is given here. [S08–S09; reused safety map from ID 3106]
The absence of an established upper intake limit or a report of adverse events does not establish safety for high-dose, long-term, pregnancy, pediatric or impaired hepatic/renal use. Arm-specific adverse-event/withdrawal denominators and long-term exposure for this MCI comparison remain unknown. Limitations of serum biotin alone for deficiency assessment were retained, and deficiency was not assumed. Research doses are not personal dosing recommendations, standard-care substitutes or instructions to change medication. [S08–S09]
## 9. Actual execution of the supplied original rubric and calculator
The supplied calculator was executed unchanged through its module functions and command line. Actual inputs were `claim_type=B`, `endpoint=P`, `replication=null`, `independence=null`, `effect=EX`, `bias=null`, and `precision=CX`; unverified design flags and `no_human_study` also remain null. P classifies the cognitive-performance question, not a verified direct instrument.
The derivation function returned **raw C** through the EX cap, but validation returned **three errors: replication, independence and bias**, and the command-line exit code was 1. None of R1/R2/R0/RX/RE means an unverified direct comparison. The precedent-29 I1-plus-disclosure fallback for inaccessible funding was considered, but mixed funding was not invented where no directly decisive study was available to classify. A separate diagnostic run inserting I1 still had two errors, replication and bias. The actual final axes were not changed.
Rubric axis 1 lines 28–44, axis 2 lines 46–58, axis 3 lines 157–179, axis 6 lines 592–629, and the no-human/EX rules at lines 678–692 were checked against the errors. The reserved `?` requires a question-specific absence-of-human-endpoint gate supported by reproducible search counts. Related human evidence and incomplete database/registry access do not establish that gate here. Nor were R0, RX, B0, I2 or zero points inserted merely because evidence was insufficient.
**Final grade=null, score=null, grading_status=not_scored_policy_gap.** Raw C, score anchors and a strength count were not adopted. No new arbitrary grade was created: the completed current value is “Unscored — policy support gap for an unverified direct comparison,” with a bounded conclusion. This is not a clinical hold. Original inputs, outputs, errors, execution environment, diagnostic run and final-adoption receipt are in `grading/`.
## 10. Search, access and verification limits
Searches on the recorded date combined biotin/B7/H/d-biotin with MCI, cognition, dementia, MoCA/MMSE/ADAS-Cog, trial/placebo/termination/registration terms, including a Korean query. Exact queries are in `search_log.json`. Web-index searches and individual source access were performed, but PubMed query, Europe PMC REST and ClinicalTrials.gov search/API access failed. WHO ICTRP, Embase and CINAHL were not directly searched. Unknown total result counts are not zero, and this is not presented as a fully exhaustive systematic review.
S01's six-page full PDF and tables/appendix were visually inspected. Only publisher page 199 of S02 was accessible; pages 200–212 were not read. S03/S05 were official abstracts; S04 used an initially accessible official abstract/caption record and indexed metadata; S06 an indexed abstract; S07 publisher HTML; S08/S09 official agency documents; S10 an indexed title/summary for instrument identity. Unopened papers, registration tables and product details were not declared verified.
No matching correction/retraction notice was identified in the bounded check, but not every publisher, Crossmark record or retraction database was inspected. This is not an all-clear certification. The original cutoff string is preserved. Web observations occurred later on the same date, without claiming reconstruction of a minute-exact historical website snapshot.
## 11. Pre-submission correction, self-review and completion state
Korean/English titles, conclusions, numbers, exclusion reasons, unknowns, safety and null grade/score were cross-checked. An internal first-build index-array key error caused a machine receipt to show zero; it was corrected to the actual `records` array, 3,154 entries and nine biotin hits, then regenerated and checked. This is a pre-submission audit event, not a correction to an already published page. Initial `corrections=[]` is retained. Original inputs and previous completion records remain unchanged.
Document quality is **A (self-assessed)**, content verification **completed_with_declared_scope**, result **completed_with_uncertainty**, and editorial/content readiness **ready_with_uncertainty**. This is same-model self-review with `independent_review=false`. The two language reports, copies of one paper, arithmetic checks and technical restoration are not independent clinical replication, independent external audit, journal certification or guarantees of zero error.
New ID, slug, URL, semantic code and first-publication date are null; publication format status is **needs_format_mapping**. This is technical mapping of an explicit unscored display and unassigned identity, not a delegated clinical re-review. There are no Codex clinical TODOs. No server access, build, deployment or live public-URL test was performed. The 30 historical HTTP-200 rows for tasks 74–78 were checked only as supplied receipts, not new observations.
Current-chat content completion changes from 0 to 1/5, separate from the five closed-chat completions. Task 80 is not started. External technical receipts distinguish exact frozen-completion/input restoration from separately recompressed archives; different compressed bytes are never called the original ZIP.
## 12. Revision conditions
A directly eligible report or registry result verifying diagnosed MCI, oral sole-added biotin, actual comparator, validated instrument/language/time, denominators and effects/variance; important full-text access; a correction/retraction or extraction error; a diagnosis/classification change; or explicit policy mapping of the unknown axes would justify revision. These are traceable triggers for a completed initial assessment, not unfinished clinical work. Once a publication identity is actually assigned, subsequent revisions should preserve that ID/URL and the prior-value history.
## Sources
- **S01**. The Integrative Personalized Functional Medicine Approach to Reverse Cognitive Decline: Academic Experience of the First 51 Patients Case Series. https://journals.sagepub.com/doi/pdf/10.1177/27536130261452680 DOI: 10.1177/27536130261452680. PMID: 42221535. - **S02**. Association of Nutrient Intakes with Cognitive Function in Koreans Aged 50 years and Older. https://www.kci.go.kr/kciportal/ci/sereArticleSearch/artiPreView.kci?sereArticleSearchBean.artiId=ART002371315&v=2019 DOI: 10.7762/cnr.2018.7.3.199. PMID: 30079318. - **S03**. Association Between Dietary Biotin Intake and Dementia Risk, Including Alzheimer's Disease: A Prospective Study of 122 959 UK Biobank Participants. https://pubmed.ncbi.nlm.nih.gov/40914826/ DOI: 10.1002/mnfr.70252. PMID: 40914826. - **S04**. Region-specific brain structural modulation and amyloid-β pathology associated with dietary biotin: insights into dementia neuropathology. https://pubmed.ncbi.nlm.nih.gov/41679193/ DOI: 10.1016/j.ebiom.2026.106155. PMID: 41679193. - **S05**. Cognitive and clinical outcomes of homocysteine-lowering B-vitamin treatment in mild cognitive impairment: a randomized controlled trial. https://pubmed.ncbi.nlm.nih.gov/21780182/ DOI: 10.1002/gps.2758. PMID: 21780182. - **S06**. A randomized placebo-controlled trial of using B vitamins to prevent cognitive decline in older mild cognitive impairment patients. https://pubmed.ncbi.nlm.nih.gov/31787369/ DOI: 10.1016/j.clnu.2019.11.005. PMID: 31787369. - **S07**. High-Dose B Vitamin Supplementation and Cognitive Decline in Alzheimer Disease: A Randomized Controlled Trial. https://jamanetwork.com/journals/jama/fullarticle/1028650 DOI: 10.1001/jama.300.15.1774. - **S08**. Biotin: Fact Sheet for Health Professionals. https://ods.od.nih.gov/factsheets/Biotin-HealthProfessional/ - **S09**. Biotin Interference with Troponin Lab Tests — Assays Subject to Biotin Interference. https://www.fda.gov/medical-devices/in-vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference - **S10**. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. https://pubmed.ncbi.nlm.nih.gov/15817019/ PMID: 15817019.
Actual access levels, locations, extracted facts and exclusion reasons are recorded in `sources.json`; cited titles are immutable publication identifiers.
Why this is classified as Unscored
Final grade null and score null. Raw C was rejected after three axis-validation errors; previous values from 3153/3154 were not copied.
Counterpoint. Actual formulation, dose, diagnosis/subtype, arm denominators, instrument/language/time, effects/variance, MCID, safety and registry/some full-text details remain unverified for a directly eligible MCI biotin comparison. Grade and score are null because the supplied policy does not support the documented unknown-axis state; new identity/display mapping remains technical work.
Rejudgment record. Explicitly unscored — Final grade null and score null. Raw C was rejected after three axis-validation errors; previous values from 3153/3154 were not copied.
| Endpoint | P | Symptom or function itself is the target - including patient reports and performance tests |
| Effect size | EX | The clinical size of the effect could not be judged |
| Precision | CX | No pooled confidence interval could be confirmed |
Review performed and remaining limitations
Actual formulation, dose, diagnosis/subtype, arm denominators, instrument/language/time, effects/variance, MCID, safety and registry/some full-text details remain unverified for a directly eligible MCI biotin comparison. Grade and score are null because the supplied policy does not support the documented unknown-axis state; new identity/display mapping remains technical work.
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Kogan et al., 2026 | Retrospective uncontrolled multimodal case series | 51 enrolled; 22 retained for at least 2.5 years; 29 discontinued in year one. MCI/AD-specific and actual biotin-exposure denominators were not reported. | No financial support reported; author ownership/advisory interests in an app and clinic were disclosed. | MoCA in retained participants; other cognitive tests, imaging and blood markers are separate. | Mean 21.7 to 22.5 is an uncontrolled within-group change, not an isolated between-group biotin effect. | Excluded from direct efficacy: multiple interventions, mixed diagnoses and no comparator. Used only as related human evidence and a boundary warning. |
| Kim et al., 2018 | Dietary intake and cognition association in Koreans aged at least 50; first page only | Total and analyzed denominators were not verified from the accessed first page. | Funding unverified; the first-page no-conflict statement is not a funding-source confirmation. | CNS Vital Signs domains and EEG theta, not a MoCA treatment effect. | Lower intake of biotin and several other nutrients in the group labeled MCI. Full diagnostic and adjusted-estimate details were inaccessible. | Excluded: dietary association rather than the incremental effect of oral biotin alone. |
| Kong et al., 2025 | Prospective UK Biobank dietary cohort | 122,959 participants; 1,256 incident dementia cases; median follow-up 11.25 years. | Funding unverified in the accessed abstract. | Incident dementia hazard by dietary intake, not a cognitive-scale difference in diagnosed MCI. | Top versus bottom quartile HR 0.67, 95% CI 0.56–0.81, for all-cause dementia is an observational association. | Excluded: dietary exposure and prevention events. Not a treatment effect with residual confounding or reverse causation ruled out. |
| Zhang et al., 2026 | UK Biobank dietary/brain-structure observations plus separate animal experiments | No question-matched arm denominator in the accessed material; the original cohort total is not substituted. | The abstract identifies National Natural Science Foundation of China support 82273619. | Dementia events/brain structure and separate mouse behavior/amyloid endpoints. | Human dietary associations and animal findings are not combined into an isolated biotin MCI cognitive effect. | Excluded: intervention, population and endpoint mismatch. Possible overlap with S03 is not independent treatment replication. |
| de Jager et al., VITACOG, 2012 | Randomized double-blind placebo-controlled MCI trial of folate/B12/B6 | 133 versus 133 participants aged at least 70; two years. | Funding unverified in this abstract-only review. | Cognitive outcomes are secondary; MMSE, CLOX, HVLT and fluency remain separate. | Favorable findings for some outcomes or higher-homocysteine subgroups are not biotin results. | Excluded: folate/B12/B6, not biotin. Other publications from the same VITACOG cohort are not new replications. |
| Kwok et al., 2020 | Randomized MCI trial of methylcobalamin/folic acid versus placebo | 279 participants aged at least 65; 24 months. | Funding unverified in the indexed abstract. | Primary CDR sum of boxes; secondary global CDR, memory/executive Z scores and depression. | No significant 24-month group difference was reported; intermediate within-group changes are not sustained between-group benefit. | Excluded: a non-biotin combination. Its nonsignificant result is not evidence that biotin is ineffective. |
| Aisen et al., 2008 | Randomized Alzheimer-disease trial of folate/B6/B12 versus placebo | 409 participants: 240 active and 169 placebo; 18 months. | NIA/NIH public support and Roche vitamin donations were confirmed; not funding for direct biotin evidence. | Primary ADAS-cog, 0–70 points with higher scores worse; baseline MMSE 14–26. | Lack of benefit on the primary rate comparison belongs to a different disease and intervention. | Excluded: AD rather than MCI and no biotin. Failures in other indications are not repeated refutations of this claim. |
| NIH ODS biotin professional fact sheet | Official nutrient and safety document | No efficacy-trial sample or arm denominator applies. | An agency document is not independent funding for a clinical efficacy trial. | Nutrient status, assay interference and limitations of high-dose safety evidence. | No established upper limit does not confirm all high-dose or long-term use is safe; susceptible assays can be biased in either direction. | Reused safety and nutrient context, not an MCI efficacy trial. |
| FDA biotin/troponin interference notice | Official regulatory safety information | No cognitive-efficacy denominator applies. | Regulatory information is a separate evidence layer. | Falsely low results in susceptible troponin assays. | This does not imply the same effect on every platform or an event in every user. | Supports a caution label, separate from cognitive efficacy. |
Receipt — 10 References
Evidence access cutoff: 2026-09-17. Each citation states its actual access level (full-text transcription, abstract, index, or other) and remaining limitations. Bibliographic checking does not certify the study results or treatment efficacy.
Technical integration by: Codex · Evidence date: 2026-09-17 · Corrections: none
Cite this verdict
[Chamgap] TASK-1039 / R01-079 — Oral sole-added biotin and cognitive function in adults with diagnosed mild cognitive impairment — Evidence Grade Unscored. 10 cited sources checked. Source: https://chamgap.com/en/verdicts/cognition/oral-sole-biotin-diagnosed-mci-cognitive-function/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
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