Eligibility Rates among Racially and Ethnically Diverse US Participants in Phase 2 and Phase 3 Placebo-Controlled, Double-Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease.
Eligibility Rates among Racially and Ethnically Diverse US Participants in Phase 2 and Phase 3 Placebo-Controlled, Double-Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease.
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Lecanemab 和 Elenbecestat 治疗早期阿尔茨海默病的 2 期和 3 期安慰剂对照、双盲、随机试验中不同种族和民族的美国参与者的合格率。
DOI：
10.1002/ana.26819
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发表时间：
2024
影响因子：
11.2
通讯作者：
Raman,Rema
中科院分区：
文献类型：
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作者：
Grill,JoshuaD;Flournoy,Charlene;Dhadda,Shobha;Ernstrom,Karin;Sperling,Reisa;Molina-Henry,Doris;Tranotti,Kate;Harris,Russell;Kanekiyo,Michio;Gee,Michelle;Irizarry,Michael;Kramer,Lynn;Aisen,Paul;Raman,Rema
目的许多因素导致阿尔茨海默病（AD）临床试验缺乏多样性。我们评估了早期阿尔茨海默病在美国大型全球多地点试验中各种族和族裔群体的适格率。方法使用4个随机、双盲、安慰剂对照的早期AD临床试验的筛选数据，在控制其他人口统计学变量的情况下，我们评估了种族和民族群体的适格率。每个试验都采用正电子发射断层扫描和/或脑脊液来评估脑淀粉样蛋白病理，以及早期AD试验中使用的典型资格标准。结果在所有试验中，10,804名美国参与者被筛选：193名（2%）为西班牙裔和黑人，2,624名（25%）为西班牙裔和白人，118名（1%）为非西班牙裔（NH）和亚洲人，696名（7%）为NH种族和黑人，7017名（65%）为NH种族和白人。不符合这些类别的156名参与者的数据被排除在外。考虑到年龄、性别和试验，并使用NH白人参与者作为参照组，我们观察到西班牙裔黑人（优势比[OR] = 3.20, 95%可信区间[CI] = 2.11-4.88）、西班牙裔白人（OR = 4.15, 95% CI = 3.58-4.83）、NH亚洲人（OR = 2.35, 95% CI = 1.23-4.55）和NH黑人（OR = 3.75, 95% CI = 2.80-5.06）参与者不符合淀粉样蛋白生物标志物标准的概率更高。解释：在早期阿尔茨海默病试验中，差异资格可能导致一些少数种族和民族的代表性不足。淀粉样蛋白生物标志物资格是确认AD诊断和使用降低淀粉样蛋白药物治疗的必要条件，并且在种族和民族群体中存在差异。Ann neurol 2024；95:288 - 298
ObjectiveMany 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.MethodsUsing screening data from 4 randomized, double‐blind, placebo‐controlled 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.ResultsAcross 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‐Hispanic 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] = 3.20, 95% confidence interval [CI] = 2.11–4.88), Hispanic White (OR = 4.15, 95% CI = 3.58–4.83), NH Asian (OR = 2.35, 95% CI = 1.23–4.55), and NH Black (OR = 3.75, 95% CI = 2.80–5.06) participants.InterpretationDifferential 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‐lowering drugs and differed among racial and ethnic groups. ANN NEUROL 2024;95:288–298