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. 2017 Feb 1;14(1-2):22-29.
eCollection 2017 Jan-Feb.

Outcomes Assessment in Clinical Trials of Alzheimer's Disease and its Precursors: Readying for Short-term and Long-term Clinical Trial Needs

Holly Posner  1 , Rosie Curiel  1 , Chris Edgar  1 , Suzanne Hendrix  1 , Enchi Liu  1 , David A Loewenstein  1 , Glenn Morrison  1 , Leslie Shinobu  1 , Keith Wesnes  1 , Philip D Harvey  1
Affiliations

Outcomes Assessment in Clinical Trials of Alzheimer's Disease and its Precursors: Readying for Short-term and Long-term Clinical Trial Needs

Holly Posner et al. Innov Clin Neurosci. .

Abstract

An evolving paradigm shift in the diagnostic conceptualization of Alzheimer's disease is reflected in its recently updated diagnostic criteria from the National Institute on Aging-Alzheimer's Association and the International Working Group. Additionally, it is reflected in the increased focus in this field on conducting prevention trials in addition to improving cognition and function in people with dementia. These developments are making key contributions towards defining new regulatory thinking around Alzheimer's disease treatment earlier in the disease continuum. As a result, the field as a whole is now concentrated on exploring the next-generation of cognitive and functional outcome measures that will support clinical trials focused on treating the slow slide into cognitive and functional impairment. With this backdrop, the International Society for CNS Clinical Trials and Methodology convened semi-annual working group meetings which began in spring of 2012 to address methodological issues in this area. This report presents the most critical issues around primary outcome assessments in Alzheimer's disease clinical trials, and summarizes the presentations, discussions, and recommendations of those meetings, within the context of the evolving landscape of Alzheimer's disease clinical trials.

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

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Conflict of interest statement

FINANCIAL DISCLOSURES:Drs. Curiel, Harvey, Hendrix, Liu, Loewenstein, Morrison, and Shinobu have no conflicts of interest relevant to the content of this article. Dr. Edgar is an employee of Roche Products Ltd. 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). Dr. Wesnes owns Wesnes Cognition Ltd, which provides services to the clinical trial industry, and owns shares in Bracket Global Inc., Wayne, Pennsylvania, USA. 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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