2022
Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer’s Disease
Budd Haeberlein S, Aisen P, Barkhof F, Chalkias S, Chen T, Cohen S, Dent G, Hansson O, Harrison K, von Hehn C, Iwatsubo T, Mallinckrodt C, Mummery C, Muralidharan K, Nestorov I, Nisenbaum L, Rajagovindan R, Skordos L, Tian Y, van Dyck C, Vellas B, Wu S, Zhu Y, Sandrock A. Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer’s Disease. The Journal Of Prevention Of Alzheimer's Disease 2022, 9: 197-210. PMID: 35542991, DOI: 10.14283/jpad.2022.30.Peer-Reviewed Original ResearchConceptsEarly Alzheimer's diseasePhase 3 studyAlzheimer's diseaseDisease dementiaAmyloid betaDisease pathophysiologyRandomized phase 3 studyClinical Dementia Rating SumCommon adverse eventsSecondary clinical endpointsPrimary outcome measureDose-dependent reductionAlzheimer's disease pathophysiologyAlzheimer's disease dementiaHuman monoclonal antibodyMild cognitive impairmentMild Alzheimer's disease dementiaPrimary endpointSecondary endpointsWeek 78Adverse eventsBiomarker substudyClinical outcomesEfficacy analysisBackgroundAlzheimer’s disease
2020
Gantenerumab in‐depth outcomes
Salloway S, Bateman R, Aschenbrenner A, Benzinger T, Clifford D, Coalier K, Cruchaga C, Fagan A, Farlow M, Goate A, Gordon B, Hassenstab J, Jack C, Koeppe R, McDade E, Mills S, Morris J, Santacruz A, Snyder P, Wang G, Xiong C, Snider B, Mummery C, Surti G, Hannequin D, Wallon D, Berman S, Lah J, Jiménez‐Velazquez I, Roberson E, van Dyck C, Honig L, Sanchez‐Valle R, Brooks W, Gauthier S, Masters C, Galasko D, Brosch J, Hsiung G, Jayadev S, Formaglio M, Masellis M, Clarnette R, Pariente J, Dubois B, Pasquier F, Baudler M, Delmar P, Doody R, Fontoura P, Kerchner G, Team D. Gantenerumab in‐depth outcomes. Alzheimer's & Dementia 2020, 16 DOI: 10.1002/alz.038049.Peer-Reviewed Original ResearchSporadic Alzheimer's diseaseAlzheimer's diseaseCognitive endpointsCDR-SBAmyloid PETBiomarker outcomesMutation carriersSecondary clinical outcomesSecondary efficacy endpointsAutosomal dominant Alzheimer's diseaseClinical trial programClinical Alzheimer's diseaseBeta monoclonal antibodySymptomatic Alzheimer's diseaseAnti-amyloid antibodiesCognitive compositeSymptomatic mutation carriersEfficacy endpointPlacebo groupPrimary outcomeClinical outcomesInitial doseFluid biomarkersTau-PETAmyloid reduction