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Review
. 2017 Feb 1;14(1-2):30-39.
eCollection 2017 Jan-Feb.

Performance-based and Observational Assessments in Clinical Trials Across the Alzheimer's Disease Spectrum

Philip D Harvey  1 , Stephanie Cosentino  1 , Rosie Curiel  1 , Terry E Goldberg  1 , Jeffrey Kaye  1 , David Loewenstein  1 , Daniel Marson  1 , David Salmon  1 , Keith Wesnes  1 , Holly Posner  1
Affiliations
Review

Performance-based and Observational Assessments in Clinical Trials Across the Alzheimer's Disease Spectrum

Philip D Harvey et al. Innov Clin Neurosci. .

Abstract

Assessment of the earlier stages of Alzheimer's disease requires different strategies than those previously developed for fully syndromal Alzheimer's disease . This challenge is further magnified in very early stages, where symptomatology may be minimal and functional deficits very subtle to absent. This paper reviews strategies for performance-based assessment of the early stages of Alzheimer's disease, including assessments of cognition, functional capacity, and social cognition. Meetings with an International Society for CNS Clinical Trials and Methodology working group served as the basis for this paper and its companion. The current state of the art of detection and staging-oriented assessments is presented, and information is provided regarding the practicality and validity of these approaches, with a special focus on their usefulness in clinical trials for new medication development.

Keywords: Early Alzheimer’s disease; clinical trials; cognition; functional assessment; mild cognitive impairment (MCI).

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Conflict of interest statement

FINANCIAL DISCLOSURES:Drs. Harvey, Cosentino, Curiel, Loewenstein, Goldberg, Kaye, Marson, Salmon, and Wesnes have no conflicts of interest relevant to the content of this article. Dr. Posner is an employee of Global Product Development, Neuroscience & Pain, Pfizer, Inc., New York, NY, USA (the work and time that went into this article were not done as part of Pfizer responsibilities). The nonprofit organization, International Society for CNS Clinical Trials (ISCTM), paid travel fees for the non-industry authors to attend ISCTM meetings that led to this paper.

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