2024
Phase 2A Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial of Nicotinamide in Early Alzheimer Disease
Grill J, Tam S, Thai G, Vides B, Pierce A, Green K, Gillen D, Teng E, Kremen S, Beigi M, Rissman R, Léger G, Balasubramanian A, Revta C, Morrison R, Jennings R, Pa J, Zhang J, Jin S, Messer K, Feldman H. Phase 2A Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial of Nicotinamide in Early Alzheimer Disease. Neurology 2024, 104: e210152. PMID: 39671543, PMCID: PMC11655133, DOI: 10.1212/wnl.0000000000210152.Peer-Reviewed Original ResearchConceptsTau phosphorylationP-tau<sub>181</sub>Histone deacetylasesCDR-SBAlzheimer's diseaseCSF p-tauPrimary outcomeP-tauDiagnosis of mild cognitive impairmentAlzheimer's Disease Assessment ScaleAlzheimer's Disease Cooperative Study-ActivitiesClass III histone deacetylasePrespecified secondary outcomesCellular oxidation-reduction reactionsDisease Assessment ScaleLevels of tauAD biomarkersHolm-Bonferroni procedureMild cognitive impairmentControl type I errorThreonine 231Histone deacetylase inhibitionAcademic clinical centersAssessment ScaleAdverse events
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
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