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
Prognostic value of plasma biomarkers in a clinical trial of mild‐to‐moderate Alzheimer’s Disease
Qiu Y, Messer K, Jacobs D, Salmon D, Kaplita S, Wellington C, Stukas S, Askew B, Brewer J, Brody M, Donahue L, Drake J, Grossman K, Hendrix S, Jicha G, Leger G, Porsteinsson A, Shadyab A, Taylor C, Thomas R, van Dyck C, Zhang J, Coric V, Qureshi I, Feldman H, Group A. Prognostic value of plasma biomarkers in a clinical trial of mild‐to‐moderate Alzheimer’s Disease. Alzheimer's & Dementia 2023, 19 DOI: 10.1002/alz.076047.Peer-Reviewed Original ResearchModerate Alzheimer's diseaseAlzheimer's Disease Cooperative StudyPlasma NfLPlasma biomarkersCDR-SBADAS-cog11Baseline NfLAlzheimer's diseaseMRI outcomesClinical trialsTrial designBaseline biomarker measurementsBaseline plasma biomarkersPlacebo-controlled RCTsClinical trial designOnly significant associationGlobal functionClinical declineClinical outcomesP-tauTotal tauTreatment armsPrognostic valueSignificant treatment effectBiomarker changes
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