Recruiting multiethnic populations to preclinical Alzheimers disease trials

项目总结 阿尔茨海默病临床前临床试验招募认知正常的参与者，他们愿意接受 疾病生物标记物测试，了解结果，并服用研究药物(或安慰剂)，如果结果表明 他们罹患疾病的风险增加了。就像阿尔茨海默病痴呆症的传统试验一样，这些试验 要求参与者向研究伙伴注册，该合作伙伴可以与参与者一起参加访问并报告 关于参与者的认知或功能能力的任何变化。这些审判面临着艰难的招募， 特别是在招募代表国家多样化人口的样本方面。了解潜力 临床前AD试验中对独特要求的不同态度将是指导 包括招募、登记和进行临床前AD试验。 该项目将研究非洲人对AD临床前试验可能存在的不同态度 美国人/黑人、亚裔美国人、西班牙裔和非西班牙裔白人老年人认知正常的个人。 该项目将重点关注这些试验中的两个关键要求：生物标记物的披露和研究伙伴 要求。有充分的理由假设，这些群体对这些问题的态度可能不同 要求。这包括我们之前对基于需求的不同态度的演示 关于个人是否会与配偶一起注册为学习伙伴以及二人组的注册模式 第一个临床前AD试验，无症状AD的抗淀粉样蛋白治疗(A4)研究。在A4中，58%的非 西班牙裔白人参与者与配偶研究伙伴一起注册，相比之下，西班牙裔参与者为45%，亚裔参与者为46%， 非裔美国人/黑人参与者的比例为27%。 该项目将为改进临床前AD试验方案设计和要求提供关键数据， 以及信息披露方面的做法，以确保尊重潜在文化的多样化和包容性招聘 对这些重要研究的要求的态度不同。

PROJECT SUMMARY Preclinical Alzheimer’s disease clinical trials enroll cognitively normal participants who are willing to undergo disease biomarker testing, learn the results, and take an investigational drug (or placebo) if those results indicate that they are at increased risk for disease. Like traditional trials in Alzheimer’s disease dementia, these trials require participants to enroll with a study partner, a person who can attend visits with the participant and report about any changes in the participant’s cognitive or functional ability. These trials face difficult recruitment, especially in enrolling samples representative of the nation’s diverse population. Understanding potential differential attitudes toward the unique requirements in preclinical AD trials will be essential to instructing inclusive recruitment, enrollment, and conduct of preclinical AD trials. This project will examine potential differential attitudes toward preclinical AD trials among African American/Black, Asian American, Hispanic, and non-Hispanic White older cognitively unimpaired individuals. The project will focus on two key requirements in these trials: biomarker disclosure and the study partner requirement. There is strong rationale to hypothesize that these groups may differ in their attitudes toward these requirements. This includes our previous demonstration of differential attitudes toward the requirements based on whether an individual would enroll with a spouse as a study partner and the enrollment patterns of dyads in the first preclinical AD trial, the Anti-Amyloid treatment in Asymptomatic AD (A4) Study. In A4, 58% of non- Hispanic White participants enrolled with a spouse study partner, compared to 45% for Hispanic, 46% for Asian, and 27% for African American/Black participants. This project will provide critical data toward improving preclinical AD trial protocol designs and requirements, as well as practices in disclosure, to ensure diverse and inclusive recruitment that respects potential cultural differences in attitudes toward the requirements of these important studies.