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Observational Study
. 2024 Aug 1;7(8):e2427073.
doi: 10.1001/jamanetworkopen.2024.27073.

A Protocol for the Inclusion of Minoritized Persons in Alzheimer Disease Research From the ADNI3 Diversity Taskforce

Ozioma C Okonkwo  1 , Monica Rivera Mindt  2   3 , Miriam T Ashford  4   5 , Catherine Conti  4   5 , Joe Strong  1 , Rema Raman  6 , Michael C Donohue  6 , Rachel L Nosheny  5   7 , Derek Flenniken  4   5 , Melanie J Miller  4   5 , Adam Diaz  4   5 , Annabelle M Soto  3 , Beau M Ances  8 , Maryam R Beigi  9 , P Murali Doraiswamy  10 , Ranjan Duara  11   12   13 , Martin R Farlow  14 , Hillel T Grossman  15 , Jacobo E Mintzer  16 , Christopher Reist  17   18   19 , Emily J Rogalski  20 , Marwan N Sabbagh  21 , Stephen Salloway  22 , Lon S Schneider  23 , Raj C Shah  24 , Ronald C Petersen  25 , Paul S Aisen  6 , Michael W Weiner  4   5   7   26   27   28 ; Alzheimer’s Disease Neuroimaging Initiative
Affiliations
Observational Study

A Protocol for the Inclusion of Minoritized Persons in Alzheimer Disease Research From the ADNI3 Diversity Taskforce

Ozioma C Okonkwo et al. JAMA Netw Open. .

Abstract

Importance: Black or African American (hereinafter, Black) and Hispanic or Latino/a/x (hereinafter, Latinx) adults are disproportionally affected by Alzheimer disease, but most research studies do not enroll adequate numbers of both of these populations. The Alzheimer's Disease Neuroimaging Initiative-3 (ADNI3) launched a diversity taskforce to pilot a multipronged effort to increase the study inclusion of Black and Latinx older adults.

Objective: To describe and evaluate the culturally informed and community-engaged inclusion efforts to increase the screening and enrollment of Black and Latinx older adults in ADNI3.

Design, setting, and participants: This cross-sectional study used baseline data from a longitudinal, multisite, observational study conducted from January 15, 2021, to July 12, 2022, with no follow-up. The study was conducted at 13 ADNI3 sites in the US. Participants included individuals aged 55 to 90 years without cognitive impairment and those with mild cognitive impairment or Alzheimer disease.

Exposures: Efforts included (1) launch of an external advisory board, (2) changes to the study protocol, (3) updates to the digital prescreener, (4) selection and deployment of 13 community-engaged research study sites, (5) development and deployment of local and centralized outreach efforts, and (6) development of a community-science partnership board.

Main outcomes and measures: Screening and enrollment numbers from centralized and local outreach efforts, digital advertisement metrics, and digital prescreener completion.

Results: A total of 91 participants enrolled in the trial via centralized and local outreach efforts, of which 22 (24.2%) identified as Latinx and 55 (60.4%) identified as Black (median [IQR] age, 65.6 [IQR, 61.5-72.5] years; 62 women [68.1%]). This represented a 267.6% increase in the monthly rate of enrollment (before: 1.11 per month; during: 4.08 per month) of underrepresented populations. For the centralized effort, social media advertisements were run between June 1, 2021, and July 31, 2022, which resulted in 2079 completed digital prescreeners, of which 1289 met criteria for subsequent site-level screening. Local efforts were run between June 1, 2021, to July 31, 2022. A total of 151 participants underwent site-level screening (100 from local efforts, 41 from centralized efforts, 10 from other sources).

Conclusions and relevance: In this cross-sectional study of pilot inclusion efforts, a culturally informed, community-engaged approach increased the inclusion of Black and Latinx participants in an Alzheimer disease cohort study.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Okonkwo reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study. Dr Ashford reported receiving grants from the National Institute on Aging (NIA) during the conduct of the study. Dr Raman reported receiving grants from the NIA during the conduct of the study. Dr Donohue reported receiving grants from the NIH during the conduct of the study and having a spouse who is a fulltime employee of Janssen and receiving consulting fees from Roche outside the submitted work. Dr Nosheny reported receiving grants from the University of California, San Francisco, during the conduct of the study and grants from the NIH, California Department of Public Health, and Genentech Charitable Foundation outside the submitted work. Dr Beigi reported receiving grants from the University of California, Los Angeles, during the conduct of the study. Dr Doraiswamy reported receiving grants from the NIA to Duke University during the conduct of the study and grants from the Department of Defense, US Highbush Blueberry Council, Cure Alzheimer Fund, the NIH, Office of Naval Research, Lilly, Karen L. Wrenn Trust, Steve Aoki Foundation, and Salix; holding stock in Transposon, UMethod, Alzheon, Marvel Biome, and Evidation; and receiving personal fees from Lumos, Prospira, Keel Digital, AHEL, Otsuka, Nutricia, Sermo, and Compass outside the submitted work; in addition, Dr Doraiswamy had a patent for diagnosis and treatment of Alzheimer disease pending. Dr Grossman reported receiving grants from the NIA during the conduct of the study. Dr Mintzer reported receiving personal fees from the AARP Global Council on Brain Health as a consultant/governance committee member; the AARP Staying Sharp as a consultant/scientific advisor; Acadia as a consultant/advisory board member; AiOmed “Finder” as a consultant; nonfinancial support from the Alzheimer’s Therapeutic Research Institute as a committee member; being a Biopharma Connex majority owner; receiving consultant fees from Corium; receiving nonfinancial support from Elder Court as a steering committee member; receiving personal fees from Exciva as a scientific advisory board member; receiving consultant fees from Genentech; receiving nonfinancial support as a consultant from ICG Pharma; receiving nonfinancial support as consultant/association member from the International Psychogeriatric Association; receiving consultant fees from Ironshore Pharmaceuticals and from Lundbeck, serving as a data safety and monitoring board member in the Nabilone for Agitation Blinded Intervention Trial; holding stock in and serving as vice-president of clinical affairs of NeuroQuest; receiving consult fees from Otsuka and Praxis Bioresearch; serving as a staff physician at Ralph H. Johnson VA Health Care System, holding stock and serving as Managing Partner of Scientific Affairs at Recruitment; receiving consultant fees from Sumitomo Pharma Co Ltd and Sygnature Discovery; receiving nonfinancial support from Technology Accelerator Company as a board member, receiving support for specific clinical trials from the NIA, Alzheimer’s Association, Eisai Inc, Cerevel Therapeutics, LLC, the National Endowment for the Arts, Alzheimer’s Drug Discovery Foundation, Cognition Therapeutics Inc, Suven Life Sciences Ltd, and Vivoryon Therapeutics outside the submitted work. Dr Rogalski reported receiving grants from the NIA during the conduct of the study and grants from the NIA outside the submitted work. Dr Sabbagh reported receiving personal fees from Genentech/Roche, Eisai, Lilly, Novo Nordisk, Synaptogenix, Neurotherapia, Prothena, KeifeRx, Anavex, Signant, T3D, and CervoMed/EIP outside the submitted work. Dr Salloway reported receiving grants from Biogen, Lilly, Genentech, Roche, EISAI, and Janssen and consultant fees from Biogen, Lilly, Genentech, EISAI, Roche, NovoNordisk, Acumen, Prothena, LabCorp, AbbVie, Alector, and Kisbee outside the submitted work. Dr Schneider reported receiving grants from the NIH, the California Department of Health Services, and the University of Southern California Alzheimer Disease Center during the conduct of the study. Dr Shah reported receiving grants paid to the Rush University Medical Center from the NIH during the conduct of the study and grants paid to Rush University Medical Center from Amylyx Pharmaceuticals Inc, Athira Pharma Inc, Edgewater NEXT, Eli Lilly & Co Inc, and Genentech Inc as site investigator for Alzheimer disease clinical trials outside the submitted work. Dr Petersen reported grants from NIH U19 AG024904 during the conduct of the study; and receiving grants from the NIH; consultant fees from Roche, Genentech Inc, Eli Lilly & Co Inc, and Nestle Inc; and serving as an unpaid consultant for Eisai Inc outside the submitted work. Dr Aisen reported receiving personal fees from Biogen, Merck, Roche, ImmunoBrain Checkpoint, and Abbvie and grants from Lilly, Eisai, and Alzheimer’s Association outside the submitted work. Dr Weiner reported receiving grants from the NIH National Institute of Neurological Disorders and Stroke and NIA from the Department of Defense the California Department of Public Health the University of Michigan Siemens, Biogen, the Hillblom Foundation, the Alzheimer’s Association, Johnson & Johnson, Kevin and Connie Shanahan, GE, VUmc, the Australian Catholic University (HBI-BHR) The Stroke Foundation, and theVeterans Administration; consultant fees from Boxer Capital LLC, Cerecin Inc, Clario, the Dementia Society of Japan, Dolby Family Ventures, Eisai, Guidepoint, Health and Wellness Partners, Indiana University, LCN Consulting, MEDA Corp, Merck Sharp & Dohme Corp, NC Registry for Brain Health, Prova Education, T3D Therapeutics, the University of Southern California, and WebMD; speaking fees with travel funding from AD/PD Congress, Amsterdam UMC, Cleveland Clinic, CTAD, Foundation of Learning, Health Society (Japan), Kenes, University of Pennsylvania, University of Toulouse, Japan Society for Dementia Research, the Korean Dementia Society, Merck Sharp & Dohme Corp, the National Center for Geriatrics and Gerontology (Japan), and the University of Southern California outside the submitted work; and Dr Weiner serves on editorial boards for Alzheimer’s & Dementia and the Journal for Prevention of Alzheimer’s Disease. He has served on advisory boards for Acumen Pharmaceutical, Alzheon Inc, Cerecin, Merck Sharp & Dohme Corp, and NC Registry for Brain Health. He also serves on the University of Southern California ACTC grant that receives funding from Eisai. He holds stock options with Alzeca, Alzheon Inc, ALZPath Inc, and Anven. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Timeline of Alzheimer’s Disease Neuroimaging Initiative-3 (ADNI3) and Diversity Taskforce (DVTF) Efforts
Figure 2.
Figure 2.. Flow Diagram of the Alzheimer’s Disease Neuroimaging Initiative-3 (ADNI3) Diversity Taskforce (DVTF) Efforts Digital Prescreener
Figure 3.
Figure 3.. Results From Local and Centralized Outreach Efforts
ADNI3 indicates Alzheimer’s Disease Neuroimaging Initiative-3; DVTF, Diversity Taskforce.
See this image and copyright information in PMC

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