title: Assessing cognition and function in Alzheimer's disease clinical trials: do we have the right tools?
abstract: Several lines of evidence from Alzheimer's disease (AD) research continue to support the notion that the biological changes associated with AD are occurring possibly several decades before an individual will experience the cognitive and functional changes associated with the disease. The National Institute on Aging-Alzheimer's Association revised criteria for AD provided a framework for this new thinking. As a result of this growing understanding, several research efforts have launched or will be launching large secondary prevention trials in AD. These and other efforts have clearly demonstrated a need for better measures of cognitive and functional change in people with the earliest changes associated with AD. Recent draft guidance from the US Food and Drug Administration further elevated the importance of cognitive and functional assessments in early stage clinical trials by proposing that even in the pre-symptomatic stages of the disease, approval will be contingent on demonstrating clinical meaningfulness. The Alzheimer's Association's Research Roundtable addressed these issues at its fall meeting October 28-29, 2013, in Washington, D.C. The focus of the discussion included the need for improved cognitive and functional outcome measures for clinical of participants with preclinical AD and those diagnosed with Mild Cognitive Impairment due to AD.
authors.affiliation: Department of Neurology, Rhode Island Hospital & Alpert Medical School of Brown University, Providence, RI, USA.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Snyder
authors.affiliation: Eli Lilly & Co, Inc., Indianapolis, IN, USA.
authors.forename: Kristin
authors.initials: K
authors.lastname: Kahle-Wrobleski
authors.affiliation: Takeda Development Center Americas, Inc., Deerfield IL, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Brannan
authors.affiliation: Bracket, Wayne, PA, USA.
authors.forename: David S
authors.initials: DS
authors.lastname: Miller
authors.affiliation: Pfizer, Inc., New York, NY, USA.
authors.forename: Rachel J
authors.initials: RJ
authors.lastname: Schindler
authors.affiliation: Piramal Pharma Inc., Boston, MA, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: DeSanti
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: J Michael
authors.initials: JM
authors.lastname: Ryan
authors.affiliation: Lumos Labs, San Francisco, CA, USA.
authors.forename: Glenn
authors.initials: G
authors.lastname: Morrison
authors.affiliation: Global R&D Partners, LLC, San Diego, CA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Grundman
authors.affiliation: Merck & Co., Whitehouse Station, NJ, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Chandler
authors.affiliation: Department of Neurology, Mayo Clinic Arizona, Scottsdale, AZ, USA.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Caselli
authors.affiliation: European Medicines Agency (EMA), London, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Isaac
authors.affiliation: Independent Science Writer, Elverson, PA, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Bain
authors.affiliation: Alzheimer's Association, Chicago, IL, USA. Electronic address: mcarrillo@alz.org.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Carrillo
mesh_terms: D000544:Alzheimer Disease / Q000150:complications / Q000523:psychology / Q000628:therapy; D002986:Clinical Trials as Topic; D003072:Cognition Disorders / Q000175:diagnosis* / Q000209:etiology*; D006801:Humans; D009483:Neuropsychological Tests
keywords: Alzheimer's disease; Biomarkers; Diagnostic criteria