Innovations In Clinical Neuroscience

JAN-FEB 2017

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

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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 ] 22 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. INTRODUCTION Alzheimer's disease (AD) is a fatal neurodegenerative disease that causes progressive cognitive, neuropsychiatric, and functional deterioration of memory and of self. Given that more than 30 million people worldwide are affected by AD, and that this number is growing dramatically, 1–3 the search for effective treatments to prevent its onset, significantly delay its progression, or by HOLLY POSNER, MD, MS; ROSIE CURIEL, PsyD; CHRIS EDGAR, PhD; SUZANNE HENDRIX, PhD; ENCHI LIU, PhD; DAVID A. LOEWENSTEIN, PhD; GLENN MORRISON, MSc, PhD; LESLIE SHINOBU, PhD; KEITH WESNES, BSc, PhD, FSS, CPsychol, FBPsS; and PHILIP D. HARVEY, PhD Dr. Posner is with Pfizer Inc., New York, New York; Drs. Curiel, Loewenstein, and Harvey are with the University of Miami Leonard Miller School of Medicine, Department of Psychiatry and Behavioral Sciences, Miami, Florida; Dr. Edgar is with Roche, Roche Products Ltd, Hertfordshire, United Kingdom; Dr. Hendrix is with Pentara Corporation, Salt Lake City, Utah; Dr. Liu is with Prothena Biosciences, Inc., South San Francisco, California; Dr. Morrison is with Lumos Labs, Inc., San Francisco, California; Dr. Shinobu is with Decibel, Therapeutics, Inc., Cambridge, Massachussetts; and Dr. Wesnes is with Wesnes Cognition Ltd., Streatley on Thames and Department of Psychology, Northumbria University, Newcastle, United Kingdom. Innov Clin Neurosci. 2017;14(1–2):22–29 FUNDING: No funding was received for the preparation of this article. 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. ADDRESS CORRESPONDENCE TO: Dr. Holly Posner, Pfizer, Inc., 235 E. 42nd Street, New York, NY 10016; email: holly.posner@pfizer.com KEY WORDS: Early Alzheimer's disease, mild cognitive impairment, MCI, clinical trials, cognition, functional assessment S P E C I A L R E P O R T Outcomes Assessment in Clinical Trials of Alzheimer's Disease and its Precursors: Readying for Short-term and Long-term Clinical Trial Needs

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