A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
Phase 2
406
about 3.7 years
50–89
47 sites in AZ, CA, FL +17
About this study
Researchers are testing whether benfotiamine, a treatment for early Alzheimer's disease, is safe and effective. The trial will last 1343 days and involve approximately 406 participants.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take High Dose Benfotiamine
- 2.Take Low Dose Benfotiamine
- 3.Take Placebo
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
Primary: Phase 2A: The rate of tolerability events (TEs)., Phase 2B: The primary cognitive endpoint is the within-participant change from baseline to 72 weeks compared between active arms (benfotiamine) and placebo on the Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13)., Phase 2B: The primary functional endpoint is the within-participant change from baseline to 72 weeks compared between active arm (benfotiamine) and placebo on the Clinical Dementia Rating - Sum of Boxes (CDR-SB).
Secondary: Number of Participants With Adverse Events (AEs) and Serious AEs., Phase 2B: within-participant change from baseline to 72 weeks compared between active (benfotiamine) arms and placebo arm on The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (ADCS-ADL-MCI)., Phase 2B: within-participant change from baseline to 72 weeks compared between active arms (benfotiamine) and placebo arm on the Montreal Cognitive Assessment (MoCA).
Neurology