2024
Examining amyloid reduction as a surrogate endpoint through latent class analysis using clinical trial data for dominantly inherited Alzheimer's disease
Wang G, Li Y, Xiong C, Benzinger T, Gordon B, Hassenstab J, Aschenbrenner A, McDade E, Clifford D, Libre‐Guerra J, Shi X, Mummery C, van Dyck C, Lah J, Honig L, Day G, Ringman J, Brooks W, Fox N, Suzuki K, Levin J, Jucker M, Delmar P, Bittner T, Bateman R, Team F. Examining amyloid reduction as a surrogate endpoint through latent class analysis using clinical trial data for dominantly inherited Alzheimer's disease. Alzheimer's & Dementia 2024 PMID: 38400532, DOI: 10.1002/alz.13735.Peer-Reviewed Original ResearchLatent classesPositron emission tomographyAmyloid reductionCognitive efficacyLatent class analysisAmyloid positron emission tomographyCognitive outcomesCognitive declineDominantly Inherited Alzheimer's Network Trials UnitSurrogate biomarkerBaseline characteristicsInherited Alzheimer's diseaseMultiple measuresClass analysisEmission tomographyTrials UnitAlzheimer's diseaseClinical trialsSurrogate endpointsTreatment effects
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