{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T05:59:31Z","timestamp":1780639171909,"version":"3.54.1"},"reference-count":30,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T00:00:00Z","timestamp":1759795200000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["A&amp;amp;D Transl Res &amp;amp; Clin Interv"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>INTRODUCTION<\/jats:title>\n                    <jats:p>Historically underrepresented racial and ethnic groups may face a higher risk and burden of dementia but continue to be underrepresented in Alzheimer's disease (AD) clinical research. Recent efforts have been insufficient to identify and address race\u2010related disparities in recruitment and eligibility for AD clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      INTERCEPT\u2010AD was a Phase 1 randomized, placebo\u2010controlled, double\u2010blind, first\u2010in\u2010human study of sabirnetug (ACU193) in participants with early symptomatic AD (mild cognitive impairment [MCI] or mild dementia due to AD). Participants were referred through seven site\u2010selected recruitment strategies across 17 study sites in the United States (June 2021\u2013January 2023). Numbers of pre\u2010screened (\n                      <jats:italic>n<\/jats:italic>\n                      = 1025), screened (\n                      <jats:italic>n<\/jats:italic>\n                      = 260), and eligible (\n                      <jats:italic>n<\/jats:italic>\n                      = 70) participants were compared by recruitment strategy. Recruitment strategy effectiveness (percentage of eligible participants among screened participants) and reasons for screening ineligibility were compared between non\u2010Hispanic White participants and participants from other racial and ethnic groups (i.e., participants who self\u2010identified as American Indian or Alaska Native, Asian, Black or African American, or Hispanic or Latino).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Local site databases were used at 13 of 17 sites (76%) and accounted for the most screened (\n                      <jats:italic>n<\/jats:italic>\n                      = 107, 41%) and eligible (\n                      <jats:italic>n<\/jats:italic>\n                      = 32, 46%) participants. Non\u2010Hispanic White participants were recruited from all seven recruitment strategies, whereas participants of other racial and ethnic groups were recruited primarily from site databases. Significantly more participants of other racial and ethnic groups were ineligible for the study after screening, largely due to ineligible amyloid positron emission tomography (PET) scans (+13.9%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DISCUSSION<\/jats:title>\n                    <jats:p>Diverse recruitment tactics, customized to capabilities of study sites and patient populations, may be more successful in recruiting diverse populations than a one\u2010size\u2010fits\u2010all approach. Although a diverse pool of potential participants was screened, a less diverse group was enrolled, largely due to race\u2010 and ethnicity\u2010related disparities in screening eligibility rates. Further investigation is needed to assess equitable screening methods for AD clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Highlights<\/jats:title>\n                    <jats:p>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>Site databases recruited the most screened and enrolled participants.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Diverse participants were primarily recruited from site databases.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>The diversity of enrolled participants was lower than screened participants.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>More ineligible participants were from diverse racial and ethnic groups.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>No approach was observed to be a one\u2010size\u2010fits\u2010all method to recruit and enroll a diverse pool of participants.<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/trc2.70161","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T03:20:11Z","timestamp":1759893611000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Recruitment and eligibility in a Phase 1 early Alzheimer's disease trial of Sabirnetug"],"prefix":"10.1002","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-9494-5447","authenticated-orcid":false,"given":"Robyn","family":"Moxon","sequence":"first","affiliation":[{"name":"Acumen Pharmaceuticals, Inc.  Newton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd","family":"Feaster","sequence":"additional","affiliation":[{"name":"Acumen Pharmaceuticals, Inc.  Newton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gopalan","family":"Sethuraman","sequence":"additional","affiliation":[{"name":"Acumen Pharmaceuticals, Inc.  Newton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alyssa","family":"Carroll","sequence":"additional","affiliation":[{"name":"Acumen Pharmaceuticals, Inc.  Newton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siew Tin","family":"Gan","sequence":"additional","affiliation":[{"name":"Acumen Pharmaceuticals, Inc.  Newton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladimir","family":"Skljarevski","sequence":"additional","affiliation":[{"name":"Acumen Pharmaceuticals, Inc.  Newton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Sundell","sequence":"additional","affiliation":[{"name":"Acumen Pharmaceuticals, Inc.  Newton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice","family":"Hitchcock","sequence":"additional","affiliation":[{"name":"Acumen Pharmaceuticals, Inc.  Newton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Siemers","sequence":"additional","affiliation":[{"name":"Acumen Pharmaceuticals, Inc.  Newton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,7]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.13809"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2017.10.009"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-2667(21)00249-8"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12362"},{"key":"e_1_2_8_6_1","unstructured":"Lecanemab\u2010irmb package insert 2023Accessed October 4 2024. Available fromhttps:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/761269Orig1s000lbl.pdf"},{"key":"e_1_2_8_7_1","unstructured":"Donanemab\u2010azbt package insert 2024Accessed October 4 2024. Available fromhttps:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/761248s000lbl.pdf"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12737"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195-023-01177-x"},{"key":"e_1_2_8_10_1","unstructured":"Enhancing the diversity of clinical trial populations \u2014 Eligibility criteria enrollment practices and trial designs guidance for industry 2020Accessed February 7 2025. Available fromhttps:\/\/regulations.gov\/document\/FDA\u20102019\u2010D\u20101264\u20100094"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/alzrt58"},{"key":"e_1_2_8_12_1","volume-title":"World Alzheimer Report 2021: Journey Through the Diagnosis of Dementia","author":"Gauthier S","year":"2021"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.14364"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/trc2.12422"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.2196\/51520"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trci.2019.09.018"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-021-00589-3"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12433"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.3233\/JAD-201081"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-024-07944-x"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.3233\/ADR-220023"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.3157"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.13304"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tjpad.2024.100005"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2022.93"},{"key":"e_1_2_8_26_1","unstructured":"GoldmanD MalzbenderK Lavin\u2010MenaMS et\u00a0al.Key barriers for clinical trials for Alzheimer's disease 2020Accessed October 4 2024. Available fromhttps:\/\/healthpolicy.usc.edu\/research\/key\u2010barriers\u2010for\u2010clinical\u2010trials\u2010for\u2010alzheimers\u2010disease\/"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2010.11.007"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2007.04.381"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2023.3599"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12205"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10072-023-07076-1"}],"container-title":["Alzheimer's &amp; Dementia: Translational Research &amp; Clinical Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/trc2.70161","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/trc2.70161","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/trc2.70161","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T05:00:52Z","timestamp":1780635652000},"score":1,"resource":{"primary":{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/10.1002\/trc2.70161"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":30,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1002\/trc2.70161"],"URL":"https:\/\/doi.org\/10.1002\/trc2.70161","archive":["Portico"],"relation":{},"ISSN":["2352-8737","2352-8737"],"issn-type":[{"value":"2352-8737","type":"print"},{"value":"2352-8737","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10]]},"assertion":[{"value":"2025-04-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-07","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70161"}}