Michael W. Weiner1,2,3,4,5,6  | Shaveta Kanoria1,6 | Melanie J. Miller1,6 | Paul S. Aisen7 | Laurel A. Beckett8 | Catherine Conti1,6 | Adam Diaz1,6 | Derek Flenniken6 | Robert C. Green9 | Danielle J. Harvey8 | Clifford R. Jack Jr.10 | William Jagust11 | Edward B. Lee12 | John C. Morris13,14,15 | Kwangsik Nho16,17 | Rachel Nosheny1,4 | Ozioma C. Okonkwo18 | Richard J. Perrin13,14,15 | Ronald C. Petersen19 | Monica Rivera-Mindt20,21 | Andrew J. Saykin16,22 | Leslie M. Shaw23 | Arthur W. Toga24 | Duygu Tosun1,2 | Dallas P. Veitch1,6 for the Alzheimer’s Disease Neuroimaging Initiative

1 Department of Veterans Affairs Medical Center, Center for Imaging of Neurodegenerative Diseases, San Francisco, California, USA

2 Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, California, USA

3 Department of Medicine, University of California San Francisco, San Francisco, California, USA

4 Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, California, USA

5 Department of Neurology, University of California San Francisco, San Francisco, California, USA

6 Northern California Institute for Research and Education (NCIRE), San Francisco, California, USA

7 Alzheimer’s Therapeutic Research Institute, University of Southern California, San Diego, California, USA

8 Division of Biostatistics, Department of Public Health Sciences, University of California, Medical Sciences 1C, Davis, California, USA

9 Division of Genetics, Department of Medicine, Brigham and Women’s Hospital, Broad Institute Ariadne Labs and Harvard Medical School, Boston, Massachusetts, USA

10 Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA

11 Helen Wills Neuroscience Institute, University of California Berkeley, Berkeley, California, USA

12 Translational Neuropathology Research Laboratory, Department of Pathology and Laboratory Medicine, Perelman School of Medicine at the University of

Pennsylvania, Philadelphia, Pennsylvania, USA

13 Knight Alzheimer’s Disease Research Center, Washington University School of Medicine, Saint Louis, Missouri, USA

14 Department of Neurology, Washington University School of Medicine, Saint Louis, Missouri, USA

15 Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, Missouri, USA

16 Department of Radiology and Imaging Sciences and the Indiana Alzheimer’s Disease Research Center, Indiana University School of Medicine, Indianapolis, Indiana, USA

17 Center for Computational Biology and Bioinformatics, Indiana University School of Medicine, Indianapolis, Indiana, USA

18 Wisconsin Alzheimer’s Disease Research Center and Department of Medicine, University of Wisconsin School of Medicine and Public Health, Clinical Science Center, Madison, Wisconsin, USA

19 Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA

20 Department of Psychology, Latin American and Latino Studies Institute, African and African American Studies, Fordham University, Bronx, New York, USA

21 Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York, USA

22 Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana, USA

23 Department of Pathology and Laboratory Medicine and the PENN Alzheimer’s Disease Research Center, Center for Neurodegenerative Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA

24 Laboratory of Neuro Imaging, Institute of Neuroimaging and Informatics, Keck School of Medicine of the University of Southern California, San Diego, California, USA

Correspondence

Michael W. Weiner, Department of Veterans Affairs Medical Center, Center for Imaging of Neurodegenerative Diseases, 4150 Clement St, San Francisco, CA 94121, USA. Email: 该Email地址已收到反垃圾邮件插件保护。要显示它您需要在浏览器中启用JavaScript。 Data used in preparation of this article were obtained from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) database (adni.loni.usc.edu). As such, the investigators within the ADNI contributed to the design and implementation of ADNI and/or provided data. Some ADNI investigators participated in analysis or writing of this report. A complete listing of ADNI investigators can be found at: http://adni.loni.usc.edu/wp content/uploads/how_to_apply/ ADNI_Acknowledgement_List.pd

Funding information

NIH, Grant/Award Number: U19 -AG 024904; National Institute on Aging, Grant/Award Number: U19AG024904

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

© 2024 The Author(s). Alzheimer’s & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer’s Association.

Abstract

The overall goal of the Alzheimer’s Disease Neuroimaging Initiative (ADNI) is to opti mize and validate biomarkers for clinical trials while sharing all data and biofluid samples with the global scientific community. ADNI has been instrumental in stan dardizing and validating amyloid beta (Aβ) and tau positron emission tomography (PET) imaging. ADNI data were used for the US Food and Drug Administration (FDA) approval of the Fujirebio and Roche Elecsys cerebrospinal fluid diagnostic tests. Additionally, ADNI provided data for the trials of the FDA-approved treatments aducanumab, lecanemab, and donanemab. More than 6000 scientific papers have been published using ADNI data, reflecting ADNI’s promotion of open science and data sharing. Despite its enormous success, ADNI has some limitations, particularly in generalizing its data and findings to the entire US/Canadian population. This introduction provides a historical overview of ADNI and highlights its significant accomplishments and future vision to pioneer “the clinical trial of the future” focusing on demographic inclusivity.

KEYWORDS

Alzheimer’s disease, Alzheimer’s disease biomarkers, Alzheimer’s disease clinical trials, Alzheimer’s Disease Neuroimaging Initiative, Alzheimer’s disease progression, amyloid, Lab oratory of Neuro Imaging, magnetic resonance imaging, neurodegeneration, positron emission tomography, post-traumatic stress disorder, tau, underrepresented populations

Highlights

∙ The Alzheimer’s Disease Neuroimaging Initiative (ADNI) introduced a novel model for public-private partnerships and data sharing.

∙ It successfully validated amyloid and Tau PET imaging, as well as CSF and plasma biomarkers, for diagnosing Alzheimer’s disease.

∙ ADNI generated and disseminated vital data for designing AD clinical trials.