2024
Protocol for 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)
Feldman H, Luchsinger J, Léger G, Taylor C, Jacobs D, Salmon D, Edland S, Messer K, Revta C, Flowers S, Jones K, Koulman A, Yarasheski K, Verghese P, Venkatesh V, Zetterberg H, Durant J, Lupo J, Gibson G, Group F. Protocol for 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). PLOS ONE 2024, 19: e0302998. PMID: 38809849, PMCID: PMC11135745, DOI: 10.1371/journal.pone.0302998.Peer-Reviewed Original ResearchConceptsPhase 2bPhase 2aRandomized double-blind placebo-controlled trialDouble-blind placebo-controlled trialCo-primary efficacy endpointsTolerability eventsBest-tolerated dosePlacebo-controlled trialWell-tolerated dosesAlzheimer's diseaseLonger-term safetyEfficacy of drug deliveryWeeks of treatmentTargeted therapeutic approachesErythrocyte transketolase activityGroups of participantsDouble-blindPlacebo armEfficacy endpointSecondary endpointsOral treatmentPharmacokinetic measurementsClinical trialsTherapeutic approachesBlood markers
2023
A Phase 2a proof‐of‐concept double‐blind, randomized, placebo‐controlled trial of nicotinamide in early Alzheimer’s disease
Grill J, Tam S, Thai G, Pierce A, Green K, Gillen D, Teng E, Kremen S, Beigi M, Rissman R, Leger G, Zhang J, Jin S, Messer K, Feldman H. A Phase 2a proof‐of‐concept double‐blind, randomized, placebo‐controlled trial of nicotinamide in early Alzheimer’s disease. Alzheimer's & Dementia 2023, 19 DOI: 10.1002/alz.077979.Peer-Reviewed Original ResearchPhase 2a proofP-Tau 181Placebo armTotal tauCDR-SBEarly ADAmyloid beta 40Placebo-controlled trialCerebrospinal fluid levelsEarly Alzheimer's diseaseAlzheimer's disease biomarkersDisease biomarkersPhosphorylation of tauClass III histoneSecondary outcomesAdverse eventsClinical characteristicsPrimary outcomeADCS-ADLStudy armsTreatment initiationCSF biomarkersADAS-Cog13Biomarker outcomesMean change