At a glance
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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)
In Brief
A Phase 2 clinical trial evaluating Low Dose Benfotiamine, High Dose Benfotiamine, and 1 other intervention for Alzheimer Disease. Active but no longer recruiting, targeting 406 participants across 47 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants will take 300mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).
Participants will take 600mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).
Participants will take placebo capsules twice a day (BID; once in the morning and once in the evening). In the placebo group, capsules will be filled with inactive microcrystalline cellulose. The other capsule components, shape and color are identical between benfotiamine and placebo arms.
Interventions
300mg benfotiamine capsules (BID, twice a day)
600mg benfotiamine capsules (BID, twice a day)
Placebo capsules to mimic benfotiamine capsules (BID, twice a day)