Innovations In Clinical Neuroscience

JAN-FEB 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Page 29 of 63

Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 4 , N U M B E R 1 – 2 , J A N U A R Y – F E B R U A R Y 2 0 1 7 ] 30 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. INTRODUCTION Cognitive and functional decline are the hallmark signs of Alzheimer's disease (AD) and related conditions. In fully syndromal AD, the detection of memory and functional deficits can be accomplished with clinical assessments not requiring formal testing, as these impairments are often quite obvious. In contrast, there are multiple challenges in assessing AD in the early stages of the illness, particularly when an individual has a high level of cognitive reserve and compensatory abilities. As described by Posner et al, 1 developing treatments are now targeting earlier stages of the illness, and mechanisms are being explored to prevent the development of AD in individuals who are at risk. It has become increasingly recognized that newly developed treatments eventually approved by the United States Food and Drug Administration (FDA) will need to employ outcome measures that translate into real world impact (i.e., how a person feels, functions, or survives). by PHILIP D. HARVEY, PhD; STEPHANIE COSENTINO, PhD; ROSIE CURIEL, PhD; TERRY E. GOLDBERG, PhD; JEFFREY KAYE, MD; DAVID LOEWENSTEIN, PhD; DANIEL MARSON, PhD, JD; DAVID SALMON, PhD; KEITH WESNES, PhD; and HOLLY POSNER, MD Drs. Harvey, Curiel, and Loewenstein are with the University of Miami Leonard Miller School of Medicine, Department of Psychiatry and Behavioral Sciences, Miami, Florida; Dr. Cosentino is with Columbia University College of Physicians and Surgeons, New York, New York; Dr. Goldberg is with North Shore Hofstra School of Medicine, Hempstead, New York; Dr. Kaye is with University of Alabama, Birmingham, Alabama; Dr. Marson is with University of Oregon, Portland, Oregon; Dr. Salmon is with USCD Medical Center, La Jolla, California; Dr. Wesnes is with Wesnes Cognition Ltd., Streatley on Thames, United Kingdom, and Department of Psychology, Northumbria University, Newcastle, United Kingdom; and Dr. Posner is with Global Product Development, Neuroscience & Pain , Pfizer, Inc., New York, New York. Innov Clin Neurosci. 2017;14(1–2):30–39 FUNDING: No funding was received for the preparation of this article. 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. ADDRESS CORRESPONDENCE TO: Dr. Philip D. Harvey, 1120 NW 14th Street, Suite 1450, Miami, FL 33136; email: KEY WORDS: Early Alzheimer's Disease, MCI, Clinical Trials, Cognition, Functional Assessment R E V I E W Performance-based and Observational Assessments in Clinical Trials Across the Alzheimer's Disease Spectrum

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