2021
Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson’s disease trial
Hutchison R, Evans K, Fox T, Yang M, Barakos J, Bedell B, Cedarbaum J, Brys M, Siderowf A, Lang A. Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson’s disease trial. BMC Neurology 2021, 21: 459. PMID: 34814867, PMCID: PMC8609885, DOI: 10.1186/s12883-021-02470-8.Peer-Reviewed Original ResearchConceptsDAT-SPECTParkinson's diseaseClinical trialsDisease trialsPhase 2 trialDopaminergic nerve terminalsEarly Parkinson's diseaseDisease-modifying therapiesIdiopathic Parkinson's diseaseMulticenter clinical trialParkinson's disease trialStudy design aspectsSingle photon emissionStages of progressionDegenerative parkinsonismEnrichment biomarkerResultsIn totalClinical assessmentNerve terminalsBlinded neuroradiologistsClinical diagnosisDopamine transporterMonoclonal antibodiesCentral laboratoryTrials
2011
Suitability of the Clinical Dementia Rating‐Sum of Boxes as a single primary endpoint for Alzheimer's disease trials
Coley N, Andrieu S, Jaros M, Weiner M, Cedarbaum J, Vellas B. Suitability of the Clinical Dementia Rating‐Sum of Boxes as a single primary endpoint for Alzheimer's disease trials. Alzheimer's & Dementia 2011, 7: 602-610.e2. PMID: 21745761, DOI: 10.1016/j.jalz.2011.01.005.Peer-Reviewed Original ResearchConceptsClinical Dementia Rating SumCo-primary endpointsPrimary endpointSingle primary endpointCDR-SBInternal responsivenessFunctional impairmentADAS-CogDisease trialsExternal responsivenessAlzheimer's diseaseAlzheimer's Disease Assessment Scale-cognitive subscaleFloor/ceiling effectsCDR-SB changeDisease-modifying trialsModerate AD patientsDaily Living ScaleAlzheimer's disease trialsConvergent validityInternal consistencyAD trialsDisease stageAD patientsInstrumental activitiesMean change