title: Performance-based and Observational Assessments in Clinical Trials Across the Alzheimer's Disease Spectrum.
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.
authors.affiliation: 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.
authors.forename: Philip D
authors.initials: PD
authors.lastname: Harvey
authors.affiliation: 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.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Cosentino
authors.affiliation: 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.
authors.forename: Rosie
authors.initials: R
authors.lastname: Curiel
authors.affiliation: 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.
authors.forename: Terry E
authors.initials: TE
authors.lastname: Goldberg
authors.affiliation: 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.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Kaye
authors.affiliation: 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.
authors.forename: David
authors.initials: D
authors.lastname: Loewenstein
authors.affiliation: 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.
authors.forename: Daniel
authors.initials: D
authors.lastname: Marson
authors.affiliation: 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.
authors.forename: David
authors.initials: D
authors.lastname: Salmon
authors.affiliation: 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.
authors.forename: Keith
authors.initials: K
authors.lastname: Wesnes
authors.affiliation: 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.
authors.forename: Holly
authors.initials: H
authors.lastname: Posner
keywords: Early Alzheimer’s disease; clinical trials; cognition; functional assessment; mild cognitive impairment (MCI)