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A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

NCT06223360 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2026-02-23

No results posted yet for this study

Summary

The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Low Dose Benfotiamine

300mg benfotiamine capsules (BID, twice a day)

DRUG

High Dose Benfotiamine

600mg benfotiamine capsules (BID, twice a day)

DRUG

Placebo

Placebo capsules to mimic benfotiamine capsules (BID, twice a day)

Sponsors & Collaborators

  • Burke Medical Research Institute

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Alzheimer's Disease Cooperative Study (ADCS)

    lead OTHER

Principal Investigators

  • Howard Feldman, MDCM · Alzheimer's Disease Cooperative Study (ADCS)

  • Gary E. Gibson, PhD · Burke Neurological Institute

  • Jose A. Luchsinger, MD MPH · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2027-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06223360 on ClinicalTrials.gov