title: Clinical trial methodologies for disease-modifying therapeutic approaches.
abstract: In recent years, advances in Alzheimer's disease (AD) biomarker research have provided powerful tools to improve trial design. In particular, biomarkers provide powerful methods for the selection of individuals with Alzheimer's disease prior to the onset of dementia. Data suggest that neuroimaging biomarkers will be useful as endpoints for trials in very early, even asymptomatic disease, though further work is necessary to establish validity for regulatory purposes.
authors: Department of Neurosciences, University of California San Diego, La Jolla, CA 92093, USA. paisen@ucsd.edu
authors: Paul S
authors: PS
authors: Aisen
mesh_terms: D000544:Alzheimer Disease / Q000175:diagnosis / Q000188:drug therapy*; D016229:Amyloid beta-Peptides / Q000134:cerebrospinal fluid; D053327:Apolipoprotein E4 / Q000235:genetics; D015415:Biomarkers; D002986:Clinical Trials as Topic / Q000379:methods*; D023381:Endpoint Determination; D018697:Nootropic Agents / Q000008:administration & dosage*; D010446:Peptide Fragments / Q000134:cerebrospinal fluid; D049268:Positron-Emission Tomography; D016896:Treatment Outcome
chemical_list: D016229:Amyloid beta-Peptides; D053327:Apolipoprotein E4; D015415:Biomarkers; D018697:Nootropic Agents; D010446:Peptide Fragments; C538897:amyloid beta-protein (40-42)