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
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take High Dose Benfotiamine
- 2.Take Low Dose Benfotiamine
- 3.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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