NIH-funded research R01 grant

Benfotiamine for early Alzheimer's disease in a Phase II trial

Official title: Phase II randomized controlled trial of benfotiamine in early Alzheimer's Disease

Funded at Weill Medical Coll of Cornell Univ · NIH-11595743 · Data updated 2026-11-12

A first-in-class blood-brain barrier form of vitamin B1 (benfotiamine) is being tested in people with early Alzheimer’s disease to see if it can help memory and thinking.

More s Disease research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionWeill Medical Coll of Cornell Univ
NIH-funded
Lab location1 site (New York, United States)
Project startJuly 15, 2022
Project endJune 30, 2028
Funding year2026
Award (this year)$8,532,455
NIH project number7R01AG076634-04
Project IDNIH-11595743 on NIH RePORTER

Who could benefit from this research

Could help

Adults with early Alzheimer's disease who meet study criteria and can participate in an 18-month randomized trial.

Less likely to help

People with advanced dementia or conditions that exclude trial participation may not benefit from this study.

What this research studies

This study continues an 18-month, randomized, placebo-controlled trial of benfotiamine for individuals in the early stages of Alzheimer’s disease. Researchers believe that boosting thiamine levels in the brain may improve metabolism, reduce brain inflammation, and lessen plaque and tangle pathology, potentially translating to better daily thinking and memory. The study builds on prior pilot data showing good tolerance and hints of cognitive benefit and aims to confirm these signals with more participants across a longer duration. Participants will receive either benfotiamine or placebo, with regular assessments of cognition, brain imaging, and biomarkers. If successful, this approach could become a new, safe oral treatment to slow progression in early Alzheimer’s disease.

Why it matters

Potential benefit: If successful, benfotiamine could slow cognitive decline and improve quality of life for people with early Alzheimer’s disease.

How similar studies have gone: Prior early-phase data suggested tolerability and potential cognitive benefits, supporting a larger Phase II/IIb trial.

Where this research is happening

  • Weill Medical Coll of Cornell Univ
    New York, United States
    Active

Researchers

  • Principal investigator: Gibson, Gary E — Weill Medical Coll of Cornell Univ
  • Study coordinator: Gibson, Gary E

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.