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

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

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

Journal article

Peer reviewed

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

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

Innovations in clinical neuroscience, Vol.14(1-2), pp.22-29

2017-01

PMCID: PMC5373792

PMID: 28386518

Abstract

functional assessment

MCI

clinical trials

mild cognitive impairment

cognition

Early Alzheimer’s disease

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.

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Title: Outcomes Assessment in Clinical Trials of Alzheimer's Disease and its Precursors: Readying for Short-term and Long-term Clinical Trial Needs
Creators: Holly Posner - 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
Rosie Curiel - 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
Chris Edgar - 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
Suzanne Hendrix - 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
Enchi Liu - 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
David A Loewenstein - 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
Glenn Morrison - 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
Leslie Shinobu - 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
Keith Wesnes - 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
Philip D Harvey - 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
Publication Details: Innovations in clinical neuroscience, Vol.14(1-2), pp.22-29
Academic Unit: Miller School of Medicine; Center on Aging; UMMG Dept of Psychiatry & Behavioral Sciences
Language: English
Resource Type: Journal article
PMID: 28386518
PMCID: PMC5373792
Record Identifier: 991031599765802976