2025
Prognostic value of plasma biomarkers for informing clinical trial design in mild-to-moderate Alzheimer’s disease
Qiu Y, Jacobs D, Messer K, Salmon D, Wellington C, Stukas S, Revta C, Brewer J, Léger G, Askew B, Donahue L, Kaplita S, Coric V, Qureshi I, Feldman H. Prognostic value of plasma biomarkers for informing clinical trial design in mild-to-moderate Alzheimer’s disease. Alzheimer's Research & Therapy 2025, 17: 97. PMID: 40317057, PMCID: PMC12046789, DOI: 10.1186/s13195-025-01745-3.Peer-Reviewed Original ResearchConceptsMild to moderate ADADAS-cog11CDR-SBBaseline plasma NfLAlzheimer's diseasePlasma biomarkersMild-to-moderate Alzheimer's diseasePrognostic valueClinical trialsBaseline NfLPlasma NfLPlacebo-controlled trialCortical volumeConcentrations of plasma biomarkersMethodsPost hoc analysisDesign of clinical trialsClinical outcome dataIncreased ventricular volumeTrial participantsVolumetric MRIBaseline concentrationsEarly disease stagesClinical trial designTrial entry criteriaAD trials
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 eventsPost hoc analysis of ADAMANT, a phase 2 clinical trial of active tau immunotherapy with AADvac1 in patients with Alzheimer’s disease, positive for plasma p-tau217
Kovacech B, Cullen N, Novak P, Hanes J, Kontsekova E, Katina S, Parrak V, Fresser M, Vanbrabant J, Feldman H, Winblad B, Stoops E, Vanmechelen E, Zilka N. Post hoc analysis of ADAMANT, a phase 2 clinical trial of active tau immunotherapy with AADvac1 in patients with Alzheimer’s disease, positive for plasma p-tau217. Alzheimer's Research & Therapy 2024, 16: 254. PMID: 39580468, PMCID: PMC11585249, DOI: 10.1186/s13195-024-01620-7.Peer-Reviewed Original ResearchConceptsClinical Dementia Rating-Sum of BoxesPhase 2 clinical trialGlial fibrillary acidic proteinPost hoc analysisAlzheimer's diseaseAlzheimer's Disease Cooperative Study ActivitiesPlasma p-tau217Clinical Dementia Rating-SumClinical trialsWhole-brain volumeSpread of tau pathologyPlasma biomarkers of neurodegenerationPlasma P-tau217 levelsMicrotubule-binding regionSubgroup of participantsADAMS participantsTau pathologyAD-related neuropathological changesCognitive declineFibrillary acidic proteinActive immunotherapyDouble-blindPlacebo-controlledVolumetric MRITau immunotherapy
2023
Efficacy assessment of an active tau immunotherapy in Alzheimer’s disease patients with amyloid and tau pathology: a post hoc analysis of the “ADAMANT” randomised, placebo-controlled, double-blind, multi-centre, phase 2 clinical trial
Cullen N, Novak P, Tosun D, Kovacech B, Hanes J, Kontsekova E, Fresser M, Ropele S, Feldman H, Schmidt R, Winblad B, Zilka N. Efficacy assessment of an active tau immunotherapy in Alzheimer’s disease patients with amyloid and tau pathology: a post hoc analysis of the “ADAMANT” randomised, placebo-controlled, double-blind, multi-centre, phase 2 clinical trial. EBioMedicine 2023, 99: 104923. PMID: 38101301, PMCID: PMC10733085, DOI: 10.1016/j.ebiom.2023.104923.Peer-Reviewed Original ResearchMeSH KeywordsAlzheimer DiseaseAmyloid beta-PeptidesBiomarkersHumansImmunotherapyImmunotherapy, Activetau ProteinsConceptsTau pathologyPathological tau proteinsAlzheimer's diseaseDouble-blindPlacebo-controlledCDR-SBTau immunotherapyTau proteinPhase 2 clinical trialAnti-tauPost hoc subgroup analysisAD-related declineDisease patientsSlowing of declineAlzheimer's disease patientsAntibody-dependent mannerAADvac1Post hoc analysisActive immunotherapyTauFull analysisParallel-groupSubgroup analysisBaseline MRIEfficacy assessment
2012
Predicting missing biomarker data in a longitudinal study of Alzheimer disease
Lo R, Jagust W, Aisen P, Jack C, Toga A, Beckett L, Gamst A, Soares H, C. Green R, Montine T, Thomas R, Donohue M, Walter S, Dale A, Bernstein M, Felmlee J, Fox N, Thompson P, Schuff N, Alexander G, DeCarli C, Bandy D, Chen K, Morris J, Lee V, Korecka M, Crawford K, Neu S, Harvey D, Kornak J, Saykin A, Foroud T, Potkin S, Shen L, Buckholtz N, Kaye J, Dolen S, Quinn J, Schneider L, Pawluczyk S, Spann B, Brewer J, Vanderswag H, Heidebrink J, Lord J, Petersen R, Johnson K, Doody R, Villanueva-Meyer J, Chowdhury M, Stern Y, Honig L, Bell K, Morris J, Mintun M, Schneider S, Marson D, Griffith R, Clark D, Grossman H, Tang C, Marzloff G, Toledo-Morrell L, Shah R, Duara R, Varon D, Roberts P, Albert M, Pedroso J, Toroney J, Rusinek H, de Leon M, De Santi S, Doraiswamy P, Petrella J, Aiello M, Clark C, Pham C, Nunez J, Smith C, Given C, Hardy P, Lopez O, Oakley M, Simpson D, Ismail M, Brand C, Richard J, Mulnard R, Thai G, Mc-Adams-Ortiz C, Diaz-Arrastia R, Martin-Cook K, DeVous M, Levey A, Lah J, Cellar J, Burns J, Anderson H, Laubinger M, Bartzokis G, Silverman D, Lu P, Graff-Radford MBBCH N, Parfitt F, Johnson H, Farlow M, Herring S, Hake A, van Dyck C, MacAvoy M, Benincasa A, Chertkow H, Bergman H, Hosein C, Black S, Graham S, Caldwell C, Hsiung G, Feldman H, Assaly M, Kertesz A, Rogers J, Trost D, Bernick C, Munic D, Wu C, Johnson N, Mesulam M, Sadowsky C, Martinez W, Villena T, Turner S, Johnson K, Behan K, Sperling R, Rentz D, Johnson K, Rosen A, Tinklenberg J, Ashford W, Sabbagh M, Connor D, Jacobson S, Killiany R, Norbash A, Nair A, Obisesan T, Jayam-Trouth A, Wang P, Lerner A, Hudson L, Ogrocki P, DeCarli C, Fletcher E, Carmichael O, Kittur S, Mirje S, Borrie M, Lee T, Bartha D, Johnson S, Asthana S, Carlsson C, Potkin S, Preda A, Nguyen D, Tariot P, Fleisher A, Reeder S, Bates V, Capote H, Rainka M, Hendin B, Scharre D, Kataki M, Zimmerman E, Celmins D, Brown A, Gandy S, Marenberg M, Rovner B, Pearlson G, Anderson K, Saykin A, Santulli R, Englert J, Williamson J, Sink K, Watkins F, Ott B, Wu C, Cohen R, Salloway S, Malloy P, Correia S, Rosen H, Miller B, Mintzer J. Predicting missing biomarker data in a longitudinal study of Alzheimer disease. Neurology 2012, 78: 1376-1382. PMID: 22491869, PMCID: PMC3345787, DOI: 10.1212/wnl.0b013e318253d5b3.Peer-Reviewed Original ResearchAlzheimer DiseaseAmyloid beta-PeptidesBiomarkersCognitive DysfunctionCohort StudiesDementia, VascularFluorodeoxyglucose F18HomocysteineHumansLogistic ModelsLongitudinal StudiesMagnetic Resonance ImagingNeuropsychological TestsPatient DropoutsPeptide FragmentsPositron-Emission TomographyResearch DesignRisk Factorstau Proteins
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