Review

. 2025 Jan;21(1):e14321.

doi: 10.1002/alz.14321. Epub 2024 Dec 22.

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

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
PMCID: PMC11775462
DOI: 10.1002/alz.14321

Review

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

Michael W Weiner et al. Alzheimers Dement. 2025 Jan.

. 2025 Jan;21(1):e14321.

doi: 10.1002/alz.14321. Epub 2024 Dec 22.

Authors

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
PMCID: PMC11775462
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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Conflict of interest statement

Dr. Weiner serves on editorial boards for Alzheimer's & Dementia, MRI, and TMRI. He has served on advisory boards for Acumen Pharmaceutical, ADNI, Alzheon, Inc., Biogen, Brain Health Registry, Cerecin, Dolby Family Ventures, Eli Lilly, Merck Sharp & Dohme Corp., National Institute on Aging (NIA), Nestle/Nestec, PCORI/PPRN, Roche, University of Southern California (USC), NervGen. He has provided consulting to Baird Equity Capital, BioClinica, Cerecin, Inc., Cytox, Dolby Family Ventures, Duke University, Eisai, FUJIFILM‐Toyama Chemical (Japan), Garfield Weston, Genentech, Guidepoint Global, Indiana University, Japanese Organization for Medical Device Development, Inc. (JOMDD), Medscape, Nestle/Nestec, NIH, Peerview Internal Medicine, Roche, T3D Therapeutics, University of Southern California (USC), and Vida Ventures. He has acted as a speaker/lecturer to The Buck Institute for Research on Aging, China Association for Alzheimer's Disease (CAAD), Japan Society for Dementia Research, and Korean Dementia Society. He holds stock options with Alzheon, Inc., Alzeca, and Anven. The following entities have provided funding for academic travel: University of Southern California (USC), NervGen, ASFNR, and CTAD Congress. Dr. Kanoria is employed by both NCIRE and Houston Methodist Academic Institute. However, only NCIRE provided financial support for the work presented in this manuscript. Dr. Beckett, Dr. Miller, Dr. Morris, Dr. Nho, Dr. Okonkwo, Dr. Perrin, Dr. Toga, Dr. Tosun, and Dr. Veitch have no conflicts to declare. Mr. Diaz, Mr. Flenniken, and Ms. Conti also have no conflicts to report. Dr. Aisen has research grants from NIH, Lilly, and Eisai, and consults with Merck, Roche, BMS, Genentech, Abbvie, Biogen, ImmunoBrain Checkpoint, and Arrowhead. Dr. Green has received compensation for advising the following companies: Allelica, Atria, Fabric, Genome Web, Genomic Life, Grail, Verily, and VinBigData and is co‐founder of Genome Medical and Nurture Genomics. Dr. Harvey serves as a statistical advisor for PLOS ONE. Dr. Nosheny receives support in the form of grants to UCSF from NIH, The Alzheimer's Association, and Genentech, Inc. Dr. Petersen has consulted for Roche, Inc., Merck, Inc., Biogen, Inc., Eisai, Inc., Nestle, Inc., and Genentech, Inc. Dr. Rivera Mindt receives support in the form of grants to Fordham University or the Icahn School of Medicine at Mount Sinai from NIH/NIA, The Alzheimer's Association, and Genentech Inc. Charitable Foundation. Dr. Okonkwo is supported by NIH grants to the University of Wisconsin‐Madison. Dr. Saykin has received support from Avid Radiopharmaceuticals, a subsidiary of Eli Lilly (in kind contribution of PET tracer precursor) and consulting fees from Bayer Oncology (Scientific Advisory Board), Eisai (Scientific Advisory Board), Siemens Medical Solutions USA, Inc. (Dementia Advisory Board), Springer‐Nature Publishing (editorial office support as editor‐in‐chief, Brain Imaging and Behavior). Dr. Shaw receives support from Roche (IIS and in‐kind reagents and instrumentation support for CSF AD biomarkers). He has also received honoraria from Roche, Biogen, and Fujirebio for participation in teaching programs and served on advisory boards for Roche and Biogen. Dr. Jack is employed by the Mayo Clinic. He receives no personal compensation from any commercial entity. He receives research support from NIH and the Alexander Family Alzheimer's Disease Research Professorship of the Mayo Clinic. Dr. Jagust has consulted for Lilly, Biogen, Clario, and Eisai and holds equity in Molecular Medicine and Optoceutics. Dr. Green has received compensation for advising the following companies: Allelica, Atria, Fabric, Genomic Life, and Juniper Genomics; and is co‐founder of Genome Medical and Nurture Genomics. J.C. Morris is funded by NIH grants # P30 AG066444; P01AG003991; P01AG026276; neither Dr. Morris nor his family owns stock or has equity interest (outside of mutual funds or other externally directed accounts) in any pharmaceutical or biotechnology company. ADNI is funded by NIH grant, U19 AG024904. Author disclosures are available in the supporting information.

Figures

**FIGURE 1**
Geographic distribution of authors contributing to ADNI publications. Researchers from the United States account for the largest share of publications (32%), followed by those from Europe (27%), China (15%), England (8%), and Canada (6%). The remaining 12% of publications are authored by researchers from other countries around the world. ADNI, Alzheimer's Disease Neuroimaging Initiative; USA, United States of America.

See this image and copyright information in PMC

References

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1. Weiner MW, Veitch DP, Aisen PS, et al. The Alzheimer's Disease Neuroimaging Initiative: a review of papers published since its inception. Alzheimers Dement. 2012;8:S1‐68. doi:10.1016/j.jalz.2011.09.172 - DOI - PMC - PubMed
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Overview of Alzheimer's Disease Neuroimaging Initiative and future clinical trials

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

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Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical