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ALZHEIMER’S DIAGNOSTIC GUIDELINE VALIDATION Exploration of Next Steps WORKSHOP SUMMARY Diana E. Pankevich, Theresa Wizemann, and Bruce M. Altevogt, Rapporteurs Forum on Neuroscience and Nervous System Disorders Board on Health Sciences Policy
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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. This project was supported by contracts between the National Academy of Sci- ences and the Alzheimer’s Association; AstraZeneca Pharmaceuticals, Inc.; CeNeRx Biopharma; the Department of Health and Human Services’ National Institutes of Health (NIH, Contract No. N01-OD-4-213) through the National Institute of Mental Health, National Institute of Neurological Disorders and Stroke; National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and National Eye Institute, NIH Blueprint for Neurosci- ence Research, Eli Lilly and Company; GE Healthcare, Inc.; GlaxoSmithKline, Inc.; Johnson & Johnson Pharmaceutical Research and Development, LLC; Merck Research Laboratories; the National Multiple Sclerosis Society; the National Science Foundation (Contract No. OIA-0753701); the Society for Neuroscience; and Wyeth Research, Inc. The views presented in this publication are those of the editors and attributing authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-22554-0 International Standard Book Number-10: 0-309-22554-X Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2012 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent ad- opted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2012. Alzheimer’s Diagnostic Guideline Validation: Exploration of Next Steps: Workshop Summary. Washington, DC: The National Academies Press.
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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.
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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding en- gineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org
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WORKSHOP ON ALZHEIMER’S DIAGNOSTIC GUIDELINE VALIDATION: EXPLORATION OF NEXT STEPS PLANNING COMMITTEE* MARILYN ALBERT, John Hopkins University GABRIELLE SILVER, GE Healthcare WILLIAM THIES, Alzheimer’s Association Study Staff BRUCE M. ALTEVOGT, Project Director DIANA E. PANKEVICH, Associate Program Officer LEILA AFSHAR, Research Associate (until August 2011) LORA K. TAYLOR, Senior Project Assistant * Institute of Medicine planning committees are solely responsible for organizing the work- shop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. v
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FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS* ALAN LESHNER (Chair), American Association for the Advancement of Science HUDA AKIL, University of Michigan MARC BARLOW, GE Healthcare, Inc. MARK BEAR, Massachusetts Institute of Technology DANIEL BURCH, CeNeRx Biopharma DENNIS CHOI, Simons Foundation TIMOTHY COETZEE, National Multiple Sclerosis Society DAVID COHEN, Columbia University JOHN DUNLOP, Pfizer, Inc. EMMELINE EDWARDS, NIH Neuroscience Blueprint RICHARD FRANK, GE Healthcare, Inc. MYRON GUTTMAN, National Science Foundation RICHARD HODES, National Institute on Aging KATIE HOOD, Michael J. Fox Foundation for Parkinson’s Research STEVEN E. HYMAN, Harvard University THOMAS INSEL, National Institute of Mental Health DANIEL JAVITT, New York University STORY LANDIS, National Institute of Neurological Disorders and Stroke HUSSEINI MANJI, Johnson & Johnson Pharmaceutical Research and Development, LLC EVE MARDER, Brandeis University DAVID MICHELSON, Merck Research Laboratories JONATHAN MORENO, University of Pennsylvania School of Medicine KATHIE OLSEN, ScienceWorks, LLC ATUL PANDE, GlaxoSmithKline, Inc. MENELAS PANGALOS, Pfizer Inc. STEVEN PAUL, Weill Cornell Medical College WILLIAM POTTER, FNIH Neuroscience Biomarker Steering Committee PAUL SIEVING, National Eye Institute RAE SILVER, Columbia University JUDITH SIUCIAK, Foundation for the National Institutes of Health MARC TESSIER-LEVIGNE, The Rockefeller University WILLIAM THIES, Alzheimer’s Association * Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. vi
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NORA VOLKOW, National Institute on Drug Abuse KENNETH WARREN, National Institute on Alcohol Abuse and Alcoholism DOUG WILLIAMSON, Lilly Research Laboratories FRANK YOCCA, AstraZeneca Pharmaceuticals STEVIN ZORN, Lundbeck USA CHARLES ZORUMSKI, Washington University School of Medicine IOM Staff BRUCE M. ALTEVOGT, Forum Director DIANA E. PANKEVICH, Associate Program Officer LORA K. TAYLOR, Senior Project Assistant ANDREW POPE, Director, Board on Health Sciences Policy vii
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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report: Jan Breslow, The Rockefeller University Howard Feldman, Bristol-Myers Squibb David Holtzman, Washington University School of Medicine Creighton Phelps, National Institute on Aging Although the reviewers listed above have provided many construc- tive comments and suggestions, they did not see the final draft of the report before its release. The review of this report was overseen by Dr. Bruce S. McEwen, The Rockefeller University. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Re- sponsibility for the final content of this report rests entirely with the author- ing committee and the institution. ix
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Contents INTRODUCTION 1 BACKGROUND 2 COMPARING THE GUIDELINES 4 VALIDATING THE NEW DIAGNOSTIC GUIDELINES: LESSONS LEARNED FROM CARDIOVASCULAR DISEASE AND CHOLESTEROL 5 MOVING FORWARD: VALIDATION OF THE NEW DIAGNOSTIC GUIDELINES 11 APPENDIXES A References 15 B Workshop Agenda 19 C Speaker Biographies 23 xi
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