← Trials/Trial dossier/NCT02292238

Benfotiamine

CompletedPhase 2Results posted

Benfotiamine in Alzheimer's Disease: A Pilot Study

Lead sponsor

Burke Medical Research Institute

Asset

Benfotiamine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1R01AG043679-01A1

Org study IDBRC-451

NCT IDNCT02292238

Timeline

Milestones

Study first posted2014-11-17estimated

Study start2015-02-15actual

Primary completion2020-07-20actual

Study completion2020-09-08actual

Last update posted2022-06-28actual

Results first posted2022-06-28actual

Assets

Drug assets

Benfotiamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•60 years of age or older

•Clinical diagnosis of AMCI by the Peterson criteria or probable AD dementia according to the National Institute of Neurological Disorders and stroke and the Alzheimer's Disease related Disorders Association (NINCDS/ADRDA)

•MMSE score > or equal to 21

•CDR score > or equal to 0.5 and < or equal to1

•Cornell Scale for Depression in Dementia(CSDD) score <10.

•Ambulatory or ambulatory with aide

•Have a caregiver willing to accompany the patient to each visit, accept responsibility for supervising treatment and provided input to clinical outcome assessments

•Reside at home

•Speak English

•Amyloid positive PET-scan

•If they are on AD medications they must be stable on AD medications for at least three months prior to baseline

•Subjects ore willing/able to provide informed consent

Exclusion criteria

•Patients with significant neurological disorder other than AD including hypoxia, stroke, traumatic brain injury

•A current psychiatric disorder according the DSM-IV diagnosis of major depression unless successfully treated on a stable dose of an antidepressant for at least 4 weeks and continues on stable dose throughout the study

•Any other DSM-IV Axis l diagnosis including other primary neurodegenerative dementia schizophrenia or bipolar depression

•A current diagnosis of uncontrolled diabetes mellitus (glucose values > 200 mg/ml).

•Patients with uncontrolled diabetes will be excluded because high glucose will alter the FDG-PET studies. The clinic that does PET (Columbia University Medical Center) excludes patients if glucose values exceed 200 mg/ml.

•A current diagnosis of active, uncontrolled seizure disorder

•A current diagnosis of probable or possible vascular dementia according to NINDS-AIREN

•An investigational drug during the previous 4 weeks

•A current diagnosis of severe unstable cardiovascular disease

•A current diagnosis of acute severe, or unstable asthmatic condition (e.g., severe chronic obstructive pulmonary disease (COPD),

•A current diagnosis of cardiac, renal or hepatic disease

•History of alcoholism, current or within past 5 years

•A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty)

•A1C less than or equal to 8

•Current diagnosis of cancer/active treatments

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Memory

Function / daily living

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

4 endpoints

Primary/protocol endpoint

Change From Baseline in ADAS-Cog Score

Time frame:Baseline, 1 year

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in ADAS-Cog Score

Time frame:Baseline, 1 year

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Benfotiaminen=34 Participants	1.39	5.63
Placebon=36 Participants	3.26	5.52

Mean Difference (Net)1.8691p0.125t-test, 2 sided

Secondary/protocol endpoint

Change From Baseline in Clinical Dementia Rating (CDR) Score

Time frame:Baseline, 1 year

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Clinical Dementia Rating (CDR) Score

Time frame:Baseline, 1 year

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Benfotiaminen=34 Participants	0.05	0.08
Placebon=36 Participants	0.22	0.06

Mean Difference (Net)0.1907p0.0337t-test, 2 sided

Memory

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Buschke Selective Reminding Test (SRT) Score

Time frame:Baseline, 1 year

change from baseline, improvement

Secondary/registry result

Change From Baseline in Buschke Selective Reminding Test (SRT) Score

Time frame:Baseline, 1 year

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Benfotiaminen=34 Participants	0.86	1.1
Placebon=36 Participants	-1.12	1

Mean Difference (Net)-1.6161p0.315t-test, 2 sided

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score

Time frame:Baseline, 1 year

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score

Time frame:Baseline, 1 year

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Benfotiaminen=34 Participants	-1.931	0.9028
Placebon=36 Participants	-3.16129	0.9816

Mean Difference (Net)-1.0636p0.3687t-test, 2 sided

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline, 1 year

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Score

Time frame:Baseline, 1 year

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Benfotiaminen=34 Participants	6.69	2.29
Placebon=36 Participants	9.23	3.8

Mean Difference (Net)1.8203p0.4850t-test, 2 sided

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Brain Glucose Utilization

Time frame:Baseline, 1 year

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Brain Glucose Utilization

Time frame:Baseline, 1 year

change from baseline, improvement

Posted result

Group	Value (mean), ratio	Standard error
Benfotiaminen=34 Participants	-0.02	0.02
Placebon=36 Participants	-0.01	0.002

Mean Difference (Net)-0.00184p0.7529t-test, 2 sided

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Gibson GE, Luchsinger JA, Cirio R, Chen H, Franchino-Elder J, Hirsch JA, Bettendorff L, Chen Z, Flowers SA, Gerber LM, Grandville T, Schupf N, Xu H, Stern Y, Habeck C, Jordan B, Fonzetti P. Benfotiamine and Cognitive Decline in Alzheimer's Disease: Results of a Randomized Placebo-Controlled Phase IIa Clinical Trial. J Alzheimers Dis. 2020;78(3):989-1010. doi: 10.3233/JAD-200896.
PMID33074237via RESULT

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.