A Seamless Phase 2A-Phase 2B Randomized Double-Blind Placebo- Controlled Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

Alzheimer's Disease Cooperative Study (ADCS)

Summary

The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease.

Description

This is a randomized, double-blind, placebo-controlled 18-month clinical trial of benfotiamine in early AD. This trial will include a seamless phase 2A-2B design with a randomized total sample of 406 participants. Participants who are randomized but drop out prior to study drug exposure will be replaced. Phase 2A of the trial will randomize approximately 150 participants total, in a 1:1:1 to treatment with 1200 mg/day benfotiamine, 600 mg/day benfotiamine or placebo. The primary objective of phase 2A is to determine the highest safe and well tolerated dose of benfotiamine (600 mg or 1200 mg),…

Eligibility

Age range: 50–89 years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * Aged 50 to 89 (inclusive) at screening * Mild Cognitive Impairment (MCI) due to AD or Mild dementia due to AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA) * Mini-Mental State Examination (MMSE) score 20-30 inclusive at screening-. Montreal Cognitive Assessment score (MoCA) \< 26 at screening * Clinical Dementia Rating (CDR) global score of 0.5 or 1 with memory score of greater or equal to 0.5 at screening * Positive plasma AD biomarker signature * Participants who are treated with FDA-app…

Interventions

Drug
Low Dose Benfotiamine
300mg benfotiamine capsules (BID, twice a day)
Drug
High Dose Benfotiamine
600mg benfotiamine capsules (BID, twice a day)
Drug
Placebo
Placebo capsules to mimic benfotiamine capsules (BID, twice a day)

Locations (47)

St. Joseph's Hospital and Medical Center/Barrow Neurological Institute
Phoenix, Arizona
Perseverance Research Center, LLC
Scottsdale, Arizona
Banner Sun Health Research Institute
Sun City, Arizona
The Neuron Clinic
Chula Vista, California
University of California, Irvine
Irvine, California
Pacific Research Network
Lemon Grove, California