Browsing by Subject "Alzheimer's disease clinical trials"

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    Overview of Alzheimer's Disease Neuroimaging Initiative and future clinical trials
    (Wiley, 2025) Weiner, Michael W.; Kanoria, Shaveta; Miller, Melanie J.; Aisen, Paul S.; Beckett, Laurel A.; Conti, Catherine; Diaz, Adam; Flenniken, Derek; Green, Robert C.; Harvey, Danielle J.; Jack, Clifford R., Jr.; Jagust, William; Lee, Edward B.; Morris, John C.; Nho, Kwangsik; Nosheny, Rachel; Okonkwo, Ozioma C.; Perrin, Richard J.; Petersen, Ronald C.; Rivera-Mindt, Monica; Saykin, Andrew J.; Shaw, Leslie M.; Toga, Arthur W.; Tosun, Duygu; Veitch, Dallas P.; Alzheimer's Disease Neuroimaging Initiative; Radiology and Imaging Sciences, School of Medicine
    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.
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    The Alzheimer's Disease Neuroimaging Initiative in the era of Alzheimer's disease treatment: A review of ADNI studies from 2021 to 2022
    (Wiley, 2024) Veitch, Dallas P.; Weiner, Michael W.; Miller, Melanie; Aisen, Paul S.; Ashford, Miriam A.; Beckett, Laurel A.; Green, Robert C.; Harvey, Danielle; Jack, Clifford R., Jr.; Jagust, William; Landau, Susan M.; Morris, John C.; Nho, Kwangsik T.; Nosheny, Rachel; Okonkwo, Ozioma; Perrin, Richard J.; Petersen, Ronald C.; Rivera Mindt, Monica; Saykin, Andrew; Shaw, Leslie M.; Toga, Arthur W.; Tosun, Duygu; Alzheimer’s Disease Neuroimaging Initiative; Radiology and Imaging Sciences, School of Medicine
    The Alzheimer's Disease Neuroimaging Initiative (ADNI) aims to improve Alzheimer's disease (AD) clinical trials. Since 2006, ADNI has shared clinical, neuroimaging, and cognitive data, and biofluid samples. We used conventional search methods to identify 1459 publications from 2021 to 2022 using ADNI data/samples and reviewed 291 impactful studies. This review details how ADNI studies improved disease progression understanding and clinical trial efficiency. Advances in subject selection, detection of treatment effects, harmonization, and modeling improved clinical trials and plasma biomarkers like phosphorylated tau showed promise for clinical use. Biomarkers of amyloid beta, tau, neurodegeneration, inflammation, and others were prognostic with individualized prediction algorithms available online. Studies supported the amyloid cascade, emphasized the importance of neuroinflammation, and detailed widespread heterogeneity in disease, linked to genetic and vascular risk, co-pathologies, sex, and resilience. Biological subtypes were consistently observed. Generalizability of ADNI results is limited by lack of cohort diversity, an issue ADNI-4 aims to address by enrolling a diverse cohort.