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

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

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

Journal article

Peer reviewed

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

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

Innovations in clinical neuroscience, Vol.14(1-2), pp.30-39

2017-01

PMCID: PMC5373793

PMID: 28386519

Abstract

mild cognitive impairment (MCI)

functional assessment

clinical trials

cognition

Early Alzheimer’s disease

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.

Metrics

18 Record Views

Details

Title: Performance-based and Observational Assessments in Clinical Trials Across the Alzheimer's Disease Spectrum
Creators: Philip D Harvey - 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
Stephanie Cosentino - 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
Rosie Curiel - 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
Terry E Goldberg - 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
Jeffrey Kaye - 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
David Loewenstein - 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
Daniel Marson - 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
David Salmon - 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
Keith Wesnes - 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
Holly Posner - 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
Publication Details: Innovations in clinical neuroscience, Vol.14(1-2), pp.30-39
Publisher: United States
Grant note: P30 AG008017 / NIA NIH HHS
Academic Unit: Miller School of Medicine; Center on Aging; UMMG Dept of Psychiatry & Behavioral Sciences
Language: English
Resource Type: Journal article
PMID: 28386519
PMCID: PMC5373793
Record Identifier: 991031561964302976