2025
evoke and evoke+: design of two large-scale, double-blind, placebo-controlled, phase 3 studies evaluating efficacy, safety, and tolerability of semaglutide in early-stage symptomatic Alzheimer’s disease
Cummings J, Atri A, Feldman H, Hansson O, Sano M, Knop F, Johannsen P, León T, Scheltens P. evoke and evoke+: design of two large-scale, double-blind, placebo-controlled, phase 3 studies evaluating efficacy, safety, and tolerability of semaglutide in early-stage symptomatic Alzheimer’s disease. Alzheimer's Research & Therapy 2025, 17: 14. PMID: 39780249, PMCID: PMC11708093, DOI: 10.1186/s13195-024-01666-7.Peer-Reviewed Original ResearchConceptsSymptomatic ADAlzheimer's diseaseDouble-blindGlucagon-like peptide-1 receptor agonist semaglutidePlacebo-controlled phase 3 trialOnce-daily oral semaglutideClinical Dementia RatingMild cognitive impairmentAD-related processesAD biomarkersSafety of semaglutideDose-escalation regimenPhase 3 studyBaseline to weekEffect of semaglutidePhase 3 trialCognitive impairmentPathophysiology of Alzheimer's diseasePotential disease-modifying effectsDementia RatingSymptomatic Alzheimer's diseaseTreatment of type 2 diabetesPlacebo-controlledType 2 diabetesDisease-modifying potential
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, LĂ©ger 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
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