Overview of Alzheimer's Disease Neuroimaging Initiative and future clinical trials

Michael W Weiner; Shaveta Kanoria; Melanie J Miller; Paul S Aisen; Laurel A Beckett; Catherine Conti; Adam Diaz; Derek Flenniken; Robert C Green; Danielle J Harvey; Clifford R Jack Jr; William Jagust; Edward B Lee; John C Morris; Kwangsik Nho; Rachel Nosheny; Ozioma C Okonkwo; Richard J Perrin; Ronald C Petersen; Monica Rivera-Mindt; Andrew J Saykin; Leslie M Shaw; Arthur W Toga; Duygu Tosun; Dallas P Veitch; Alzheimer's Disease Neuroimaging Initiative

doi:10.1002/alz.14321

Overview of Alzheimer's Disease Neuroimaging Initiative and future clinical trials

Alzheimers Dement. 2024 Dec 22. doi: 10.1002/alz.14321. Online ahead of print.

Authors

Michael W Weiner^{1

2

3

4

5

6}, Shaveta Kanoria^{1

6}, Melanie J Miller^{1

6}, Paul S Aisen⁷, Laurel A Beckett⁸, Catherine Conti^{1

6}, Adam Diaz^{1

6}, Derek Flenniken⁶, Robert C Green⁹, Danielle J Harvey⁸, Clifford R Jack Jr¹⁰, William Jagust¹¹, Edward B Lee¹², John C Morris^{13

14

15}, Kwangsik Nho^{16

17}, Rachel Nosheny^{1

4}, Ozioma C Okonkwo¹⁸, Richard J Perrin^{13

14

15}, Ronald C Petersen¹⁹, Monica Rivera-Mindt^{20

21}, Andrew J Saykin^{16

22}, Leslie M Shaw²³, Arthur W Toga²⁴, Duygu Tosun^{1

2}, Dallas P Veitch^{1

6}; Alzheimer's Disease Neuroimaging Initiative

Affiliations

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.

PMID: 39711072
DOI: 10.1002/alz.14321

Abstract

The overall goal of the Alzheimer's Disease Neuroimaging Initiative (ADNI) is to optimize and validate biomarkers for clinical trials while sharing all data and biofluid samples with the global scientific community. ADNI has been instrumental in standardizing 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. 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.

Keywords: Alzheimer's Disease Neuroimaging Initiative; Alzheimer's disease; Alzheimer's disease biomarkers; Alzheimer's disease clinical trials; Alzheimer's disease progression; Laboratory of Neuro Imaging; amyloid; magnetic resonance imaging; neurodegeneration; positron emission tomography; post‐traumatic stress disorder; tau; underrepresented populations.

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Review

Abstract

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