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/dayA multicenter, randomized, double-blind, placebo-controlled ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Posiphen in subjects with early Alzheimer’s Disease
Galasko D, Farlow M, Lucey B, Honig L, Elbert D, Bateman R, Momper J, Thomas R, Rissman R, Pa J, Aslanyan V, Balasubramanian A, West T, Maccecchini M, Feldman H. A multicenter, randomized, double-blind, placebo-controlled ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Posiphen in subjects with early Alzheimer’s Disease. Alzheimer's Research & Therapy 2024, 16: 151. PMID: 38970127, PMCID: PMC11225352, DOI: 10.1186/s13195-024-01490-z.Peer-Reviewed Original ResearchConceptsOrally administered small moleculeFractional synthesis rateAscending dose studyDose-dependent loweringIRB-approved protocolEarly ADMini-Mental State ExamDose-dependent effectAlzheimer's diseaseBlood patchDouble-blindWell-toleratedCatheter placementPreclinical modelsLumbar punctureDose studyIntravenous infusionMild cognitive impairmentEvaluate safetyPlacebo participantsCognitive measuresStable isotope labeling kineticsActive drugClinical trialsADAS-Cog12
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