2023
Longitudinal head-to-head comparison of 11C-PiB and 18F-florbetapir PET in a Phase 2/3 clinical trial of anti-amyloid-β monoclonal antibodies in dominantly inherited Alzheimer’s disease
Chen C, McCullough A, Gordon B, Joseph-Mathurin N, Flores S, McKay N, Hobbs D, Hornbeck R, Fagan A, Cruchaga C, Goate A, Perrin R, Wang G, Li Y, Shi X, Xiong C, Pontecorvo M, Klein G, Su Y, Klunk W, Jack C, Koeppe R, Snider B, Berman S, Roberson E, Brosch J, Surti G, Jiménez-Velázquez I, Galasko D, Honig L, Brooks W, Clarnette R, Wallon D, Dubois B, Pariente J, Pasquier F, Sanchez-Valle R, Shcherbinin S, Higgins I, Tunali I, Masters C, van Dyck C, Masellis M, Hsiung R, Gauthier S, Salloway S, Clifford D, Mills S, Supnet-Bell C, McDade E, Bateman R, Benzinger T. Longitudinal head-to-head comparison of 11C-PiB and 18F-florbetapir PET in a Phase 2/3 clinical trial of anti-amyloid-β monoclonal antibodies in dominantly inherited Alzheimer’s disease. European Journal Of Nuclear Medicine And Molecular Imaging 2023, 50: 2669-2682. PMID: 37017737, PMCID: PMC10330155, DOI: 10.1007/s00259-023-06209-0.Peer-Reviewed Original ResearchConceptsStandardized uptake value ratioPhase 2/3 clinical trialsPositron emission tomographyAnti-Aβ monoclonal antibodyClinical trialsPlacebo armDrug effectsLongitudinal changesMonoclonal antibodiesGlobal cortical standardized uptake value ratioHead comparisonCortical standardized uptake value ratioRegional standardized uptake value ratiosAβ positron emission tomographyAmyloid-β positron emission tomographyAlzheimer's disease clinical trialsPET imagingUptake value ratioAβ PET imagingSimulated clinical trialTwo-sample t-testDrug armPittsburgh CompoundPET scansWelch two sample t-testDisease severity and minimal clinically important differences in clinical outcome assessments for Alzheimer's disease clinical trials
Van Dyck C, O'Dell R, Mecca A. Disease severity and minimal clinically important differences in clinical outcome assessments for Alzheimer's disease clinical trials. Alzheimer's & Dementia: Translational Research & Clinical Interventions 2023, 9: e12388. PMID: 37187779, PMCID: PMC10175943, DOI: 10.1002/trc2.12388.Peer-Reviewed Original ResearchAlzheimer's disease clinical trialsClinical outcome assessmentClinical trialsOutcome assessmentDisease severityImportant differences
2012
P2‐414: Baseline clinical scores and volumetric MRI parameters across subjects randomized in mild‐to‐moderate (BMS CN156‐013) and predementia (BMS CN156‐018) Alzheimer's disease clinical trials of avagacestat
Bracoud L, Coric V, van Dyck C, Andreasen N, Ross J, Brody M, Curtis C, Belaroussi B, Yu H, Kaplita S, Feldman H, Pachai C, Berman R. P2‐414: Baseline clinical scores and volumetric MRI parameters across subjects randomized in mild‐to‐moderate (BMS CN156‐013) and predementia (BMS CN156‐018) Alzheimer's disease clinical trials of avagacestat. Alzheimer's & Dementia 2012, 8: p409-p409. DOI: 10.1016/j.jalz.2012.05.2039.Peer-Reviewed Original ResearchAlzheimer's disease clinical trialsBaseline clinical scoresClinical scoresClinical trialsMRI parametersIC‐P‐140: Baseline clinical scores and volumetric MRI parameters across subjects randomized in mild‐to‐moderate (BMS CN156‐013) and predementia (BMS CN156‐018) Alzheimer's disease clinical trials of avagacestat
Bracoud L, Coric V, van Dyck C, Andreasen N, Ross J, Brody M, Curtis C, Belaroussi B, Yu H, Kaplita S, Feldman H, Pachai C, Berman R. IC‐P‐140: Baseline clinical scores and volumetric MRI parameters across subjects randomized in mild‐to‐moderate (BMS CN156‐013) and predementia (BMS CN156‐018) Alzheimer's disease clinical trials of avagacestat. Alzheimer's & Dementia 2012, 8: p73-p74. DOI: 10.1016/j.jalz.2012.05.174.Peer-Reviewed Original ResearchAlzheimer's disease clinical trialsBaseline clinical scoresClinical scoresClinical trialsMRI parameters