NIA-AA Research Framework
NEW DRAFT as of September 19
Edited based on prior feedback.
Available for comment.
In 2011, the National Institute on Aging (NIA) at National Institutes of Health (NIH) and the Alzheimer's Association published revised guidelines (NIA-AA) for modernization of the diagnosis of Alzheimer's disease. In these guidelines, the workgroups identified Alzheimer's disease as a continuum with three distinct stages: Preclinical, Mild Cognitive Impairment and Dementia. A number of studies noted the need to develop a framework to describe the changes throughout the disease continuum, including the clinical context and the pathophysiologic changes, for an individual. In 2016, the NIA and Alzheimer's Association convened an international workgroup of scientific experts tasked with the evaluation of the existing guidelines. The workgroup discussions are on going.
The NIA-AA workgroup's goal is to define Alzheimer's disease and stage it across both the pathophysiologic and clinical continua. The NIA-AA workgroup proposes that Alzheimer's disease should be defined as a pathophysiological construct. As in other diseases, such as osteoporosis or diabetes, biomarkers would alone define the presence of the disease in a living person regardless of their symptoms. Clinical symptoms assist in staging the clinical severity of the disease. Here the NIA-AA workgroup shares an update on their discussions of this conceptual model for the proposed framework and the research needed to validate it.
The goal of the framework is to advance the field in understanding the pathophysiology of Alzheimer's and allow for testing of hypotheses related to development and progression of disease in diverse populations and settings. Discussions during the Alzheimer's Association International Conference (AAIC) contributed to the workgroup's thinking and revision process. An updated draft as of September 19, 2017 is posted in the link below for comment. The committee will review and discuss all comments.
The NIA-AA leadership formed the workgroup whose charge was to examine the 2011 guidelines in the context of current scientific knowledge and, if appropriate, update them. NIA-AA leadership selected members of the workgroup to achieve a range of scientific expertise, the broad representation of different institutions (public, academic and private) and professional organizations involved with AD research, and geographic and gender diversity. Given the importance of the framework to support research studies testing clinical interventions, scientific expertise included regulatory science via a representative of the U.S. Food & Drug Administration. The process of framework development included public presentations of the draft document at various scientific forums, a website providing the most recent draft and the opportunity for web-based feedback. The site will remain open for comment through the writing stage as well as post-publication.
David A. Bennett, M.D.
Rush Alzheimer's Disease Center, Rush University Medical Center
Kaj Blennow, M.D., Ph.D.
Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital
Billy Dunn, M.D.
Division of Neurology Products, U.S. Food and Drug Administration
David M. Holtzman, M.D.
Department of Neurology, Washington University, St Louis
Clifford R. Jack, Jr., M.D.
Radiology Department, Mayo Clinic
William Jagust, M.D.
Helen Wills Neuroscience Institute, University of California, Berkley, Berkley
Frank Jessen, M.D.
Department of Psychiatry, University of Cologne
Jason Karlawish, M.D.
Departments of Medicine, Medical Ethics and Health Policy, and Neurology, University of Pennsylvania,
Enchi Liu, Ph.D.
Prothena Biosciences, Inc.
Jose Luis Molinuevo, M.D.
Department of Neurology, ICN Hospital Clinic i Universitari and Pasqual Maragall Foundation
Thomas Montine, M.D.
Department of Pathology, Stanford University
Creighton Phelps, Ph.D.
(Retired) National Institute on Aging at the National Institutes of Health
Katherine P. Rankin, Ph.D.
Department of Neurology, University of California San Francisco
Christopher Rowe, M.D.
Department of Molecular Imaging, Austin Health, University of Melbourne
Philip Scheltens, M.D.
Alzheimer Center, VU University Medical Center
Eric Siemers, M.D.
Biomedicines Business Unit, Alzheimer's Disease Platform Team
Reisa Sperling, M.D.
Department of Neurology, Brigham and Women's Hospital and Massachusetts General Hospital, Harvard Medical School
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