{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T16:42:20Z","timestamp":1792082540382,"version":"4.4.0"},"reference-count":38,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,10,25]],"date-time":"2023-10-25T00:00:00Z","timestamp":1698192000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Annals of Neurology"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Many factors contribute to inadequate diversity in Alzheimer disease (AD) clinical trials. We evaluated eligibility rates among racial and ethnic groups at US sites in large global multisite trials in early AD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Using screening data from 4 randomized, double\u2010blind, placebo\u2010controlled clinical trials in early AD, we assessed rates of eligibility among racial and ethnic groups controlling for other demographic covariates. Each trial incorporated positron emission tomography and\/or cerebrospinal fluid to evaluate brain amyloid pathology, as well as typical eligibility criteria used in early AD trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Across the trials, 10,804 US participants were screened: 193 (2%) were of Hispanic ethnicity and Black race, 2,624 (25%) were of Hispanic ethnicity and White race, 118 (1%) were of non\u2010Hispanic ethnicity (NH) and Asian race, 696 (7%) were of NH ethnicity and Black race, and 7,017 (65%) were of NH ethnicity and White race. Data from 156 participants who did not fit into these categories were excluded. Accounting for age, sex, and trial and using NH White participants as a reference group, we observed higher probabilities of ineligibility for amyloid biomarker criteria among Hispanic Black (odds ratio [OR]\u2009=\u20093.20, 95% confidence interval [CI] =\u20092.11\u20134.88), Hispanic White (OR\u2009=\u20094.15, 95% CI\u2009=\u20093.58\u20134.83), NH Asian (OR\u2009=\u20092.35, 95% CI\u2009=\u20091.23\u20134.55), and NH Black (OR\u2009=\u20093.75, 95% CI\u2009=\u20092.80\u20135.06) participants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p>Differential eligibility may contribute to underrepresentation of some minoritized racial and ethnic groups in early AD trials. Amyloid biomarker eligibility is a requirement to confirm the diagnosis of AD and for treatment with amyloid\u2010lowering drugs and differed among racial and ethnic groups. ANN NEUROL 2024;95:288\u2013298<\/jats:p><\/jats:sec>","DOI":"10.1002\/ana.26819","type":"journal-article","created":{"date-parts":[[2023,10,13]],"date-time":"2023-10-13T13:43:15Z","timestamp":1697204595000},"page":"288-298","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":37,"title":["Eligibility Rates among Racially and Ethnically Diverse <scp>US<\/scp> Participants in Phase 2 and Phase 3 Placebo\u2010Controlled, Double\u2010Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease"],"prefix":"10.1002","volume":"95","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4215-7589","authenticated-orcid":false,"given":"Joshua D.","family":"Grill","sequence":"first","affiliation":[{"name":"Institute for Memory Impairments and Neurological Disorders, Departments of Psychiatry and Human Behavior and Neurobiology and Behavior University of California, Irvine  Irvine CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlene","family":"Flournoy","sequence":"additional","affiliation":[{"name":"Alzheimer's Therapeutic Research Institute University of Southern California  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shobha","family":"Dhadda","sequence":"additional","affiliation":[{"name":"Eisai Inc  Nutley NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin","family":"Ernstrom","sequence":"additional","affiliation":[{"name":"Alzheimer's Therapeutic Research Institute University of Southern California  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reisa","family":"Sperling","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital, Massachusetts General Hospital  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doris","family":"Molina\u2010Henry","sequence":"additional","affiliation":[{"name":"Alzheimer's Therapeutic Research Institute University of Southern California  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Tranotti","sequence":"additional","affiliation":[{"name":"Eisai Inc  Nutley NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell","family":"Harris","sequence":"additional","affiliation":[{"name":"Eisai Inc  Nutley NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michio","family":"Kanekiyo","sequence":"additional","affiliation":[{"name":"Eisai Inc  Nutley NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Gee","sequence":"additional","affiliation":[{"name":"Eisai Co Ltd  Hatfield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Irizarry","sequence":"additional","affiliation":[{"name":"Eisai Inc  Nutley NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynn","family":"Kramer","sequence":"additional","affiliation":[{"name":"Eisai Inc  Nutley NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Aisen","sequence":"additional","affiliation":[{"name":"Alzheimer's Therapeutic Research Institute University of Southern California  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rema","family":"Raman","sequence":"additional","affiliation":[{"name":"Alzheimer's Therapeutic Research Institute University of Southern California  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,10,25]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/trc2.12295"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2018.06.3063"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12433"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2215609"},{"key":"e_1_2_9_6_1","unstructured":"National Academies of Sciences Engineering and Medicine.Improving representation in clinical trials and research: building research equity for women and underrepresented groups 2022."},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2018.09.009"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.14364"},{"key":"e_1_2_9_9_1","unstructured":"US Food and Drug Administration.Diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials; draft guidance for industry 2022. Accessed April 26 2022."},{"key":"e_1_2_9_10_1","volume-title":"U.S. Department of Health and Human Services","author":"Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research Food and Drug Administration","year":"2020"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195-021-00813-8"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2212948"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.2104"},{"key":"e_1_2_9_14_1","volume-title":"R: a language and environment for statistical computing","author":"R Core Team","year":"2022"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1017\/S104161020700511X"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.3157"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2021.0399"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2018.4249"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000002914"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195-017-0315-1"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2019.17363"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(12)70142-4"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001831"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001834"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.3233\/JAD-2009-1227"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2016.03.004"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.3233\/JAD-180992"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2018.1123"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.0268"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2020.3536"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000011599"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001877"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2015.06.1893"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.2274"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.18865\/ed.30.S2.705"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2023.30"},{"key":"e_1_2_9_37_1","first-page":"398","article-title":"Aducanumab: appropriate use recommendations","volume":"8","author":"Cummings J","year":"2021","journal-title":"J Prev Alzheimers Dis"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2023.0123"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/ana.25948"}],"container-title":["Annals of Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ana.26819","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,26]],"date-time":"2024-01-26T14:17:40Z","timestamp":1706278660000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ana.26819"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,25]]},"references-count":38,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,2]]}},"alternative-id":["10.1002\/ana.26819"],"URL":"https:\/\/doi.org\/10.1002\/ana.26819","archive":["Portico"],"relation":{},"ISSN":["0364-5134","1531-8249"],"issn-type":[{"value":"0364-5134","type":"print"},{"value":"1531-8249","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10,25]]},"assertion":[{"value":"2023-07-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-09","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}