Browsing by Author "Okonkwo, Ozioma C."

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    Increasing participant diversity in AD research: Plans for digital screening, blood testing, and a community-engaged approach in the Alzheimer's Disease Neuroimaging Initiative 4
    (Wiley, 2023) Weiner, Michael W.; Veitch, Dallas P.; Miller, Melanie J.; Aisen, Paul S.; Albala, Bruce; Beckett, Laurel A.; Green, Robert C.; Harvey, Danielle; Jack, Clifford R., Jr.; Jagust, William; Landau, Susan M.; Morris, John C.; 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; Trojanowski, John Q.; Alzheimer's Disease Neuroimaging Initiative; Radiology and Imaging Sciences, School of Medicine
    Introduction: The Alzheimer's Disease Neuroimaging Initiative (ADNI) aims to validate biomarkers for Alzheimer's disease (AD) clinical trials. To improve generalizability, ADNI4 aims to enroll 50-60% of its new participants from underrepresented populations (URPs) using new biofluid and digital technologies. ADNI4 has received funding from the National Institute on Aging beginning September 2022. Methods: ADNI4 will recruit URPs using community-engaged approaches. An online portal will screen 20,000 participants, 4000 of whom (50-60% URPs) will be tested for plasma biomarkers and APOE. From this, 500 new participants will undergo in-clinic assessment joining 500 ADNI3 rollover participants. Remaining participants (∼3500) will undergo longitudinal plasma and digital cognitive testing. ADNI4 will add MRI sequences and new PET tracers. Project 1 will optimize biomarkers in AD clinical trials. Results and discussion: ADNI4 will improve generalizability of results, use remote digital and blood screening, and continue providing longitudinal clinical, biomarker, and autopsy data to investigators.
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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-4 (ADNI-4) Engagement Core: A culturally informed, community-engaged research (CI-CER) model to advance brain health equity
    (Wiley, 2024) Rivera Mindt, Mónica; Arentoft, Alyssa; Calcetas, Amanda T.; Guzman, Vanessa A.; Amaza, Hannatu; Ajayi, Adeyinka; Ashford, Miriam T.; Ayo, Omobolanle; Barnes, Lisa L.; Camuy, Alicia; Conti, Catherine; Diaz, Adam; Easter, Bashir; Gonzalez, David J.; Graham Dotson, Yolanda; Hoang, Isabella; Germano, Kaori Kubo; Maestre, Gladys E.; Magaña, Fabiola; Meyer, Oanh L.; Miller, Melanie J.; Nosheny, Rachel; Ta Park, Van M.; Parkins, Shaniya; Renier Thomas, Lisa; Strong, Joe; Talavera, Sandra; Verney, Steven P.; Weisensel, Trinity; Weiner, Michael W.; Okonkwo, Ozioma C.; Alzheimer's Disease Neuroimaging Initiative; Medicine, School of Medicine
    Introduction: The Alzheimer's Disease Neuroimaging Initiative-4 (ADNI-4) Engagement Core was launched to advance Alzheimer's disease (AD) and AD-related dementia (ADRD) health equity research in underrepresented populations (URPs). We describe our evidence-based, scalable culturally informed, community-engaged research (CI-CER) model and demonstrate its preliminary success in increasing URP enrollment. Methods: URPs include ethnoculturally minoritized, lower education (≤ 12 years), and rural populations. The CI-CER model includes: (1) culturally informed methodology (e.g., less restrictive inclusion/exclusion criteria, sociocultural measures, financial compensation, results disclosure, Spanish Language Capacity Workgroup) and (2) inclusive engagement methods (e.g., the Engagement Core team; Hub Sites; Community-Science Partnership Board). Results: As of April 2024, 60% of ADNI-4 new in-clinic enrollees were from ethnoculturally or educationally URPs. This exceeds ADNI-4's ≥ 50% URP representation goal for new enrollees but may not represent final enrollment. Discussion: Findings show a CI-CER model increases URP enrollment in AD/ADRD clinical research and has important implications for clinical trials to advance health equity. Highlights: The Alzheimer's Disease Neuroimaging Initiative-4 (ADNI-4) uses a culturally informed, community-engaged research (CI-CER) approach. The CI-CER approach is scalable and sustainable for broad, multisite implementation. ADNI-4 is currently exceeding its inclusion goals for underrepresented populations.
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    The Consortium for Clarity in ADRD Research Through Imaging (CLARiTI)
    (Wiley, 2025) Mormino, Elizabeth C.; Biber, Sarah A.; Rahman-Filipiak, Annalise; Arfanakis, Konstantinos; Clark, Lindsay; Dage, Jeffrey L.; Detre, John A.; Dickerson, Bradford C.; Donohue, Michael C.; Kecskemeti, Steven; Hohman, Timothy J.; Jagust, William J.; Keene, Dirk C.; Kukull, Walter; Levendovszky, Swati R.; Rosen, Howie; Thompson, Paul M.; Villemagne, Victor L.; Wolk, David A.; Okonkwo, Ozioma C.; Rabinvovici, Gil D.; Rivera-Mindt, Monica; Foroud, Tatiana; Johnson, Sterling C.; Neurology, School of Medicine
    The presence of multiple pathologies is the largest predictor of dementia. A major gap in the field is the in vivo detection of mixed pathologies and their antecedents. The Alzheimer's Disease Research Centers (ADRCs) are uniquely positioned to address this gap. The ADRCs longitudinally follow ≈ 17,000 participants, ranging from cognitively unimpaired to dementia, arising from Alzheimer's disease (AD) and related dementias (ADRD; e.g., AD, Lewy body disorders, vascular). Motivated by the Alzheimer's Disease Neuroimaging Initiative's (ADNI) impact, the ADRC Consortium for Clarity in ADRD Research Through Imaging (CLARiTI) was formed. Leveraging existing ADRC infrastructure, CLARiTI will integrate standardized imaging and plasma collection to characterize mixed pathologies and use community-engaged research methods to ensure that ≥ 25% of the sample is from underrepresented populations (e.g., ethnoculturally minoritized, low education). The resulting ADRD profiles, within a more diverse sample, will provide key resources for ADRCs and an unprecedented, more generalizable publicly available imaging-plasma dataset. HIGHLIGHTS: In vivo detection of mixed pathologies is critical for Alzheimer's disease and related dementias research. The Alzheimer's Disease Research Centers (ADRCs) are uniquely positioned to address gaps related to mixed pathologies. The ADRC Consortium for Clarity in ADRD Research Through Imaging (CLARiTI) will enhance this national program by adding standardized imaging and plasma collection to existing ADRC infrastructure. This effort will provide key resources for ADRCs and an unprecedented publicly available imaging-plasma-neuropath dataset.