Benfotiamine for early Alzheimer's disease
Official title: Phase II randomized controlled trial of benfotiamine in early Alzheimer's Disease
Funded at Winifred Masterson Burke Med Res Inst · NIH-10891398 · Data updated 2026-11-12
This trial tests whether benfotiamine, a form of vitamin B1, can improve memory and slow decline in people with early Alzheimer's disease.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Winifred Masterson Burke Med Res Inst NIH-funded |
| Lab location | 1 site (White Plains, United States) |
| Project start | July 15, 2022 |
| Project end | June 30, 2028 |
| Funding year | 2025 |
| Award (this year) | $9,592,233 |
| NIH project number | 5R01AG076634-03 |
| Project ID | NIH-10891398 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with a diagnosis of early Alzheimer's disease or mild cognitive impairment due to Alzheimer's who meet the study's eligibility criteria and can attend regular clinic visits are the ideal candidates.
✕Less likely to help
People with advanced Alzheimer's disease, non-Alzheimer dementias, or medical issues that make participation unsafe are unlikely to benefit from this trial.
What this research studies
You would be randomly assigned to take benfotiamine or a placebo for roughly 18 months in a double-blind Phase 2A/2B design. The study uses oral benfotiamine doses informed by earlier work and tracks safety, blood and brain-related biomarkers (such as neurofilament light and GFAP), and standard cognitive measures like the CDR and ADAS‑Cog. Clinic visits include medication checks, blood draws, cognitive testing, and possibly imaging, and neither participants nor study staff will know who receives active drug versus placebo. The trial builds on animal studies and a small pilot human trial that suggested encouraging pharmacologic and cognitive signals.
Why it matters
Potential benefit: If successful, benfotiamine could improve memory and slow disease progression in people with early Alzheimer's disease.
How similar studies have gone: A prior 12-month pilot randomized trial and multiple animal studies showed promising safety, biomarker, and cognitive signals, but larger trials are needed to confirm benefit.
Where this research is happening
-
Winifred Masterson Burke Med Res Inst
White Plains, United States Active
Researchers
- Principal investigator: Gibson, Gary E — Winifred Masterson Burke Med Res Inst
- Study coordinator: Gibson, Gary E
Related research
Other NIH-funded projects on the same topics.
-
Benfotiamine for early Alzheimer's disease in a Phase II trial
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.
-
Ear health and memory: can hearing aids help prevent cognitive decline in adults at risk for Alzheimer's
A focused study will test whether using hearing aids can help 55-75 year olds with early hearing loss keep their thinking sharper and reduce risk for Alzheimer’s-related changes.
-
Move2Joy: a personalized mobile program to boost activity and lower dementia risk
A mobile health program helps middle-aged and older adults stay physically active to reduce the chance of developing Alzheimer’s disease and related dementias.
-
Using hearing aids to help protect memory and thinking in people with early hearing loss
This trial will test whether providing hearing-aid based support to people aged 55–75 with early hearing loss and mild memory problems can slow memory decline and related brain changes linked to Alzheimer's disease.
-
Investigating the effects of indoor cycling on slowing Alzheimer's disease progression in older adults at genetic risk.
This study is looking at how high-intensity indoor cycling might help protect the brain health of healthy older adults aged 65 to 80 who have a specific gene linked to Alzheimer's disease, by comparing their cognitive function and brain scans before and after the exercise program.
-
Investigating how early hearing loss may relate to Alzheimer's disease
This study is looking at how using hearing aids might help people aged 55 to 75 with early hearing loss and mild memory issues, by seeing if better hearing can improve their thinking skills and social connections, possibly helping to prevent further memory decline.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.