2023
Investigating Partially Discordant Results in Phase 3 Studies of Aducanumab
Mallinckrodt C, Tian Y, Aisen P, Barkhof F, Cohen S, Dent G, Hansson O, Harrison K, Iwatsubo T, Mummery C, Muralidharan K, Nestorov I, Nisenbaum L, Rajagovindan R, von Hehn C, van Dyck C, Vellas B, Wu S, Zhu Y, Sandrock A, Chen T, Budd Haeberlein S. Investigating Partially Discordant Results in Phase 3 Studies of Aducanumab. The Journal Of Prevention Of Alzheimer's Disease 2023, 10: 171-177. PMID: 36946443, DOI: 10.14283/jpad.2023.6.Peer-Reviewed Original ResearchConceptsHigh-dose armAmyloid-related imaging abnormalitiesPhase 3 studyBaseline characteristicsImaging abnormalitiesAlzheimer's diseaseDiscordant resultsParallel-group studyHigh-dose groupMild AD dementiaEarly Alzheimer's diseaseMild cognitive impairmentSecondary endpointsTreatment armsAD dementiaAmyloid pathologyMulticenter studyRapid progressionSignificant treatment effectSafety resultsTarget dosePatientsAducanumabCognitive impairmentNon-significant difference
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