Benfotiamine for early Alzheimer's disease
Phase II randomized controlled trial of benfotiamine in early Alzheimer's Disease
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 ID | NIH-10891398 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: 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.
Not a fit: People with advanced Alzheimer's disease, non-Alzheimer dementias, or medical issues that make participation unsafe are unlikely to benefit from this trial.
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 performed: 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
White Plains, United States
- 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
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 below.