Alzheimer Therapeutic Research Institute, Keck School of Medicine, University of Southern California, San Diego.
Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
JAMA Netw Open. 2021 Jul 1;4(7):e2114364. doi: 10.1001/jamanetworkopen.2021.14364.
Underrepresentation of many racial/ethnic groups in Alzheimer disease (AD) clinical trials limits generalizability of results and hinders opportunities to examine potential effect modification of candidate treatments.
To examine racial and ethnic differences in recruitment methods and trial eligibility in a multisite preclinical AD trial.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed screening data from the Anti-Amyloid in Asymptomatic AD study, collected from April 2014 to December 2017. Participants were categorized into 5 mutually exclusive ethnic/racial groups (ie, Hispanic, Black, White, Asian, and other) using participant self-report. Data were analyzed from May through December 2020 and included 5945 cognitively unimpaired older adults between the ages of 65 and 85 years screened at North American study sites.
Primary outcomes included recruitment sources, study eligibility, and ineligibility reasons. To assess the probability of trial eligibility, regression analyses were performed for the likelihood of being eligible after the first screening visit involving clinical and cognitive assessments.
Screening data were included for 5945 participants at North American sites (mean [SD] age, 71.7 [4.9] years; 3524 women [59.3%]; 5107 White [85.9%], 323 Black [5.4%], 261 Hispanic [4.4%], 112 Asian [1.9%], and 142 [2.4%] who reported race or ethnicity as other). Recruitment sources differed by race and ethnicity. While White participants were recruited through a variety of sources, site local recruitment efforts resulted in the majority of Black (218 [69.2%]), Hispanic (154 [59.7%]), and Asian (61 [55.5%]) participants. Participants from underrepresented groups had lower mean years of education (eg, mean [SD] years: Hispanic participants, 15.5 [3.2] years vs White participants, 16.7 [2.8] years) and more frequently were women (226 [70.0%] Black participants vs 1364 [58.5%] White participants), were unmarried (184 [56.9%] Black participants vs 1364 [26.7%] White participants), and had nonspousal study partners (237 [73.4%] Black participants vs 2147 [42.0%] White participants). They were more frequently excluded for failure to meet cognitive inclusion criteria (eg, screen failures by specific inclusion criteria: 147 [45.5%] Black participants vs 1338 [26.2%] White participants). Compared with White participants, Black (odds ratio [OR], 0.43; 95% CI, 0.34-0.54; P < .001), Hispanic (OR, 0.53; 95% CI, 0.41-0.69; P < .001), and Asian participants (OR, 0.56; 95% CI, 0.38-0.82; P = .003) were less likely to be eligible after screening visit 1.
Racial/ethnic groups differed in sources of recruitment, reasons for screen failure, and overall probability of eligibility in a preclinical AD trial. These results highlight the need for improved recruitment strategies and careful consideration of eligibility criteria when planning preclinical AD clinical trials.
许多种族/族裔群体在阿尔茨海默病（AD）临床试验中的代表性不足，限制了研究结果的普遍性，并阻碍了对候选治疗方法的潜在效果修饰的研究机会。
检查一项多中心临床前 AD 试验中招募方法和试验资格的种族和民族差异。
设计、地点和参与者：这项横断面研究分析了 2014 年 4 月至 2017 年 12 月期间从北美研究点收集的无症状 AD 抗淀粉样蛋白研究的筛查数据。参与者使用参与者的自我报告分为 5 个相互排斥的种族/族裔群体（即西班牙裔、黑人、白人、亚洲人和其他）。数据分析于 2020 年 5 月至 12 月进行，包括在北美研究点接受筛查的 5945 名年龄在 65 岁至 85 岁之间认知正常的老年人。
主要结果包括招募来源、研究资格和不合格原因。为了评估试验资格的可能性，对首次涉及临床和认知评估的筛查后符合资格的可能性进行了回归分析。
包括北美研究点的 5945 名参与者的筛查数据（平均[标准差]年龄，71.7[4.9]岁；3524 名女性[59.3%]；5107 名白人[85.9%]，323 名黑人[5.4%]，261 名西班牙裔[4.4%]，112 名亚洲人[1.9%]，142 名[2.4%]报告种族或族裔为其他）。招募来源因种族和族裔而异。虽然白人参与者通过各种来源招募，但现场当地的招募工作导致大多数黑人（218[69.2%]）、西班牙裔（154[59.7%]）和亚洲人（61[55.5%]）参与者。代表性不足的群体的平均受教育年限较低（例如，平均[标准差]年数：西班牙裔参与者，15.5[3.2]年与白人参与者，16.7[2.8]年），更多的是女性（226[70.0%]黑人参与者与 1364[58.5%]白人参与者）、未婚（184[56.9%]黑人参与者与 1364[26.7%]白人参与者）和没有配偶的研究伙伴（237[73.4%]黑人参与者与 2147[42.0%]白人参与者）。他们因不符合认知纳入标准而更频繁地被排除在外（例如，根据具体纳入标准的筛查失败：147[45.5%]黑人参与者与 1338[26.2%]白人参与者）。与白人参与者相比，黑人（比值比[OR]，0.43；95%置信区间[CI]，0.34-0.54；P<0.001）、西班牙裔（OR，0.53；95%CI，0.41-0.69；P<0.001）和亚洲人（OR，0.56；95%CI，0.38-0.82；P=0.003）在第 1 次筛查后符合资格的可能性较低。
种族/族裔群体在临床前 AD 试验中的招募来源、筛选失败的原因以及总体资格可能性方面存在差异。这些结果强调了在计划临床前 AD 临床试验时需要改进招募策略和仔细考虑资格标准。
