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
2019
Effect of AZD0530 on Cerebral Metabolic Decline in Alzheimer Disease
van Dyck CH, Nygaard HB, Chen K, Donohue MC, Raman R, Rissman RA, Brewer JB, Koeppe RA, Chow TW, Rafii MS, Gessert D, Choi J, Turner RS, Kaye JA, Gale SA, Reiman EM, Aisen PS, Strittmatter SM. Effect of AZD0530 on Cerebral Metabolic Decline in Alzheimer Disease. JAMA Neurology 2019, 76: 1219-1229. PMID: 31329216, PMCID: PMC6646979, DOI: 10.1001/jamaneurol.2019.2050.Peer-Reviewed Original ResearchAZD0530 treatmentAdverse eventsPrimary outcomeTreatment groupsAlzheimer's Disease Cooperative Study-ActivitiesAlzheimer's diseasePositron emission tomography evidenceMini-Mental State Examination scoreAlzheimer's Disease Assessment Scale-cognitive subscaleCerebral metabolic declineFrequent adverse eventsSecondary end pointsCerebral metabolic rateMild Alzheimer's dementiaState Examination scorePlasma drug levelsClinical Dementia RatingVolumetric magnetic resonanceEffect of AZD0530Neuronal cell surfaceModified intentionTreat populationSecondary outcomesNeuropsychiatric InventoryEfficacy analysis