title: Recommended cognitive outcomes in preclinical Alzheimer's disease: Consensus statement from the European Prevention of Alzheimer's Dementia project.
abstract: The Horizon 2020/IMI European Prevention of Alzheimer's Dementia (EPAD) project will undertake large-scale proof-of-concept trials in predementia Alzheimer's disease (AD). Within EPAD, the monitoring of cognitive trajectories in the preclinical period will constitute a central outcome measure; however, there are currently no clear guidelines as to how this should be achieved as most measures have been developed for the period around dementia diagnosis. The EPAD Scientific Advisory Group for Clinical and Cognitive Outcomes identified appropriate cognitive measures based on a literature search covering both cognitive correlates of preclinical brain changes from imaging studies and cognitive changes observed over time in nondementia population cohorts developing incident dementia. These measures were evaluated according to the following criteria: validity, coherence with biomarker changes, psychometric properties, cross-cultural suitability, availability of alternative forms, and normative data limited practice effects. The resulting consensus statement provides recommendations for both future drug trials and research into preclinical Alzheimer's disease.
authors.affiliation: Institut National de la Sante et de la Recherche Medicale, U1061 Neuropsychiatrie, Montpellier, France; University of Montpellier, Montpellier, France; Centre for Dementia Prevention, University of Edinburgh, Edinburgh, UK. Electronic address: karen.ritchie@inserm.fr.
authors.forename: Karen
authors.initials: K
authors.lastname: Ritchie
authors.affiliation: Clinical Research, Neurosciences, Janssen, South San Francisco, CA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Ropacki
authors.affiliation: Clinical Research, Neuroscience and General Medicine, Eisai Inc, Woodcliff Lake, NJ, USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Albala
authors.affiliation: Metis Cognition Ltd, Kilmington Common, UK; Alzheimer Center VUmc, Amsterdam, Holland.
authors.forename: John
authors.initials: J
authors.lastname: Harrison
authors.affiliation: Neurology and Biomedical Engineering, Oregon Health and Science University, Portand, OR, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Kaye
authors.affiliation: Department of Neurology Memory and Ageing Centre, University of California at San Francisco, San Francisco, CA, USA.
authors.forename: Joel
authors.initials: J
authors.lastname: Kramer
authors.affiliation: Department of Neurology, Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Randolph
authors.affiliation: Centre for Dementia Prevention, University of Edinburgh, Edinburgh, UK.
authors.forename: Craig W
authors.initials: CW
authors.lastname: Ritchie
mesh_terms: D000544:Alzheimer Disease / Q000175:diagnosis* / Q000523:psychology*; D002986:Clinical Trials as Topic; D003071:Cognition; D006801:Humans; D009483:Neuropsychological Tests; D062706:Prodromal Symptoms
keywords: Alzheimer's disease; Cognition; Neuropsychology; Preclinical