Recruiting multiethnic populations to preclinical Alzheimers disease trials

招募多种族人群参与临床前阿尔茨海默病试验

基本信息

批准号：
10677736
负责人：
Joshua Grill
金额：
$ 19.63万
依托单位：
UNIVERSITY OF CALIFORNIA-IRVINE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-15 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10677736
关键词：
Acceleration Activities of Daily Living Address Affect African American Age Alzheimer disease prevention Alzheimer&apos s Disease Alzheimer&apos s disease related dementia Alzheimer’s disease biomarker Amyloid Asian Asian Americans Asian population Assessment tool Attitude Biological Markers Black Populations Black race Clinical Trials Clinical Trials Design Cognitive Communities Data Dementia Development Disclosure Disease Disparity Disparity in diagnosis Early Intervention Elderly Enrollment Ensure Ethics Ethics Committees Ethnic Population Face Failure Funding Future Goals Hispanic Hispanic Populations Human Impaired cognition Incentives Individual Intervention Intervention Studies Investigational Drugs Learning Literature Methods Not Hispanic or Latino Participant Pattern Persons Phase Placebos Population Heterogeneity Protocols documentation Public Health Published Comment Race Reporting Research Research Personnel Risk Role Safety Sampling Site Social Justice Spouses Testing Trust Visit asymptomatic Alzheimer&apos s disease clinical trial enrollment cognitive ability cognitive interview cohort design disorder risk ethnic difference experimental study health disparity improved informant multi-ethnic novel participant enrollment pre-clinical preclinical trial programs racial difference racial population recruit therapy development trial design willingness

项目摘要

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.

项目摘要阿尔茨海默氏症临床试验的认知正常参与者愿意接受如果这些结果表明疾病生物标志物测试，学习结果并服用研究药物（或安慰剂）他们的疾病风险增加。就像阿尔茨海默氏病痴呆症中的传统试验一样，这些试验要求参与者与学习伙伴一起注册，一个可以与参与者一起访问并报告的人参与者的认知或功能能力的任何变化。这些试验面临困难的招聘，特别是在注册样品中代表美国潜水员的人口。了解潜力临床前广告试验中对独特要求的差异吸引力对于指导至关重要临床前广告试验的包容性招聘，入学和行为。该项目将检查非洲临床前广告试验的潜在差分吸引力美国/黑人，亚裔美国人，西班牙裔和非西班牙裔白人年龄较大的认知单独的人。该项目将重点介绍这些试验中的两个关键要求：生物标志物披露和研究合作伙伴要求。有很强的理由可以假设这些群体的与会者在这些群体方面可能有所不同要求。这包括我们以前的差异参与者展示了基于要求的关于个人是否将与配偶作为学习伙伴和二元组的入学模式第一次临床前AD试验，非对称AD（A4）研究中的抗淀粉样蛋白治疗。在A4中，58％的非 - 西班牙裔白人参与者参加了配偶学习伙伴，而西班牙裔则为45％，亚洲人为46％非裔美国人/黑人参与者为27％。该项目将提供关键数据，以改善临床前广告试验协议设计和要求，以及披露的实践，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出勤差异。