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FUTURE OPPORTUNITIES TO LEVERAGE THE ALZHEIMER'S DISEASE NEUROIMAGING INITIATIVE

WORKSHOP SUMMARY

Theresa Wizemann, Diana E. Pankevich, and Bruce M. Altevogt, Rapporteurs

Forum on Neuroscience and Nervous System Disorders

Board on Health Sciences Policy

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu



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FUTURE OPPORTUNITIES TO LEVERAGE THE ALZHEIMER'S DISEASE NEUROIMAGING INITIATIVE WORKSHOP SUMMARY Theresa Wizemann, Diana E. Pankevich, 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, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This project was supported by contracts between the National Academy of Sciences 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 on Aging, National Insti- tute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, National Eye Institute, NIH Blueprint for Neuroscience Research, National Institute of Mental Health, and National Institute of Neurological Disorders and Stroke; 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: 978-0-309-16188-6 International Standard Book Number-10: 0-309-16188-6 Additional copies of this report are available from The National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2011 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 adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Cover legend: Current ADNI sites: North America (NA), Europe (E), Japan (J), and Australia (A). Future sites: Argentina (Arg), China (C), Korea (K), and Thailand (T). Suggested citation: IOM (Institute of Medicine). 2011. Future Opportunities to Leverage the Alzheimer’s Disease Neuroimaging Initiative: 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 engineers. 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 ADNI: WHAT’S NExT? STATE-OF-THE-ART METHODS FOR ExPLORINg CNS DEvELOPMENTAL AND NEuRODEgENERATIvE DISORDERS RESEARCH PLANNINg COMMITTEE* WILLIAM THIES (Cochair), Alzheimer’s Association WILLIAM POTTER (Cochair), FNIH Neuroscience Biomarker Steering Committee Study Staff BRuCE M. ALTEvOgT, Project Director, IOM LORA K. TAYLOR, Senior Project Assistant, IOM ___________________________ * IOM planning committees are solely responsible for organizing the workshop, 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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INSTITuTE OF MEDICINE 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 DAvID BREDT, Eli Lilly and Company DANIEL BuRCH, CeNeRx Biopharma DENNIS CHOI, Emory University TIMOTHY COETzEE, National Multiple Sclerosis Society DAvID COHEN, Columbia University EMMELINE EDWARDS, NIH Neuroscience Blueprint RICHARD FRANK, GE Healthcare, Inc. JOHN gRIFFIN, Johns Hopkins University School of Medicine MYRON guTTMAN, National Science Foundation (since June 2010) RICHARD HODES, National Institute on Aging KATIE HOOD, Michael J. Fox Foundation for Parkinson’s Research STEvEN HYMAN, Harvard University THOMAS INSEL, National Institute of Mental Health 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, Association of Public and Land-Grant Universities ATuL PANDE, GlaxoSmithKline, Inc. MENELAS PANgALOS, Pfizer Inc STEvEN PAuL, Eli Lilly and Company (until February 2010) WILLIAM POTTER, FNIH Neuroscience Biomarker Steering Committee PAuL SIEvINg, National Eye Institute RAE SILvER, Columbia University WILLIAM THIES, Alzheimer’s Association ___________________________ * IOM forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rappor- teurs and the institution. vi

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NORA vOLKOW, National Institute on Drug Abuse KENNETH WARREN, National Institute on Alcohol Abuse and Alcoholism FRANK YOCCA, AstraZeneca Pharmaceuticals STEvIN zORN, Lundbeck USA CHARLES zORuMSKI, Washington University School of Medicine IOM Staff BRuCE M. ALTEvOgT, Forum Director SARAH L. HANSON, Associate Program Officer (until June 2010) DIANA E. PANKEvICH, Associate Program Officer (since October 2010) 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: Randall Bateman, Washington University School of Medicine zaven Khachaturian, Keep Memory Alive Mary Savage, Merck & Co., Inc. John Trojanowski, University of Pennsylvania School of Medicine 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 Sid gilman, University of Michigan, William J. Herdman Distinguished Uni- versity Professor of Neurology. 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. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. ix

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Contents INTRODuCTION 1 BACKgROuND 1 SESSION OvERvIEW 4 KEY ELEMENTS OF ADNI: WHAT LESSONS CAN BE LEARNED FOR MOvINg FORWARD? 7 MOvINg FORWARD: OPPORTuNITIES AND FuTuRE SYNERgIES FOR ADNI 2 17 APPENDIxES A References 19 B Workshop Agenda 21 xi

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