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Recruiting Phase 2 NCT06223360

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

Trial Parameters

Condition Alzheimer Disease
Sponsor Alzheimer's Disease Cooperative Study (ADCS)
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 406
Sex ALL
Min Age 50 Years
Max Age 89 Years
Start Date 2024-03-28
Completion 2027-12-01
Interventions
Low Dose BenfotiamineHigh Dose BenfotiaminePlacebo

Brief 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.

Eligibility 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-approved acetylcholinesterase inhibitors (AchEI)and/or memantine will have to be on a stable dosage regimen for at least 3 months prior to screening. * Participants must have a study partner who has frequent interaction with them (approximately \>3-4 times per week), will be available for all clinic visits in person or remotely, and can assist in compliance with study procedures. * Female participants

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