title: Clinical trials in predementia stages of Alzheimer disease.
abstract: Effective treatments of Alzheimer disease (AD) dementia are an urgent necessity. There is a growing consensus that effective disease-modifying treatment before the onset of clinical dementia and slowing the progression of mild symptoms are needed after recent setbacks in AD therapeutics. The identification of at-risk and preclinical AD populations is becoming important for targeting primary and secondary prevention clinical trials in AD. This article reviews the strategies and challenges in targeting at-risk and preclinical AD populations for a new generation of AD clinical trials. Design, outcome measures, and complexities in successfully completing a clinical trial targeting this population are reviewed.
authors: Lou Ruvo Center for Brain Health, Cleveland Clinic, Cleveland, OH 44195, USA. pillaij@ccf.org
authors: Jagan A
authors: JA
authors: Pillai
authors: Jeffrey L
authors: JL
authors: Cummings
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics / Q000523:psychology; D058070:Asymptomatic Diseases; D002986:Clinical Trials as Topic; D003071:Cognition / Q000187:drug effects; D060825:Cognitive Dysfunction / Q000175:diagnosis / Q000188:drug therapy / Q000235:genetics / Q000523:psychology; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use*; D005819:Genetic Markers / Q000235:genetics; D020022:Genetic Predisposition to Disease / Q000235:genetics; D006801:Humans; D009483:Neuropsychological Tests; D018697:Nootropic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018579:Patient Selection; D011322:Primary Prevention; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D016896:Treatment Outcome
chemical_list: D015507:Drugs, Investigational; D005819:Genetic Markers; D018697:Nootropic Agents