A Seamless Phase 2A‐Phase 2B Multi‐Center Trial to Test the Benefits of Benfotiamine on the Progression of Alzheimer’s Disease‐Benfoteam: Design and Methods
Luchsinger J, Feldman H, Messer K, Edland S, Leger G, Jacobs D, Salmon D, Revta C, Lupo J, Durant J, Gibson G. A Seamless Phase 2A‐Phase 2B Multi‐Center Trial to Test the Benefits of Benfotiamine on the Progression of Alzheimer’s Disease‐Benfoteam: Design and Methods. Alzheimer's & Dementia 2024, 20: e091963. PMCID: PMC11714007, DOI: 10.1002/alz.091963.Peer-Reviewed Original ResearchPhase 2bDosing decisionsPerson-months of exposureLonger-term safetyWeeks of treatmentCo-primary endpointsClinically significant benefitBiomarker test resultsMulti-center trialTolerated doseDouble-blindEvaluate safetySmall molecule treatmentBlood levelsActive treatmentPhase 2aThiamine deficiencyPerson-monthsDoseCohen's d effect sizesPharmacological effectsTherapeutic directionsBenfotiamineGlucose metabolismMg/day
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