The study partner requirement in preclinical Alzheimers disease trials

阿尔茨海默病临床前试验中研究伙伴的要求

• 批准号: 9373717
• 负责人: Daniel L Gillen
• 金额: $ 22.25万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9373717
• 关键词: Activities of Daily Living; Adherence; Affect; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease model; Amyloid; Biological Markers; Characteristics; Clinical Trials; Cognition; Cognitive; Communities; Data; Decision Making; Dementia; Disclosure; Disease; Elements; Eligibility Determination; Enrollment; Ensure; Ethical Issues; Ethics; Face; Future; Goals; Gold; Impaired cognition; Inferior; Investigational Drugs; Knowledge; Learning; Logistics; Longitudinal Studies; Machine Learning; Measures; Memory; Neuropsychological Tests; Outcome; Outcome Measure; Participant; Patients; Performance; Persons; Placebos; Positioning Attribute; Prevention; Prevention trial; Protocols documentation; Recommendation; Recruitment Activity; Reporting; Research; Research Design; Research Personnel; Role; Safety; Sampling; Test Result; Testing; Trust; Visit; base; cognitive ability; cognitive function; cognitive performance; cognitive testing; cooperative study; data integrity; design; disorder risk; eligible participant; improved; informant; instrument; learning strategy; neuroimaging; pre-clinical; preclinical trial; preference; prevent; programs; secondary analysis; social stigma; trial design; willingness

Project Summary/Abstract 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. Like traditional trials in Alzheimer's disease dementia, these trials face logistical challenges related to difficult recruitment. We recently showed that the requirement for a participant to learn their Alzheimer's disease biomarker status was not a barrier to successful recruitment. In contrast, the requirement of enrolling with a study partner was a significant barrier to participation for many potential enrollees. We also observed results that suggested that the study partner barrier was related to the requirement of biomarker testing and disclosure. This project will further investigate the study partner role in preclinical Alzheimer's disease clinical trials. First, we will explore the ethical implications of the study partner requirement, specifically whether this requirement is a barrier to enrollment because participants are unwilling to share their biomarker results with others. Second, we examine the scientific need for study partners, by measuring informants' accuracy and precision in assessing cognitive performance, predicting cognitive decline, and recognizing subtle changes in cognition, and comparing to participants' abilities to perform these roles themselves. These studies will provide valuable data toward improving preclinical AD trial protocol designs, assisting investigators making decisions around 1) whether to require study partners, 2) who is qualified to fill this role, and 3) how participants should be protected against potential stigma related to their eligibility.

项目总结/摘要 临床前阿尔茨海默病临床试验招募愿意接受治疗的认知正常参与者 疾病生物标志物检测，了解结果，并采取研究药物（或安慰剂），如果这些结果 表明他们患病的风险增加。就像阿尔茨海默病痴呆症的传统试验一样， 试验要求参与者与研究伙伴一起登记，研究伙伴是可以与参与者一起参加访视的人， 报告参与者认知或功能能力的任何变化。就像阿尔茨海默病的传统试验一样 然而，这些试验面临着与招募困难有关的后勤挑战。我们最近展示了 要求参与者了解他们的阿尔茨海默病生物标志物状态并不是一个障碍， 成功招聘。相比之下，与研究伙伴一起入组的要求是一个重大障碍， 许多潜在的参与者。我们还观察到的结果表明， 障碍与生物标志物检测和披露的要求有关。 该项目将进一步研究研究伙伴在临床前阿尔茨海默病临床试验中的作用。第一、 我们将探讨研究伴侣要求的伦理含义，特别是这一要求是否 因为参与者不愿意与他人分享他们的生物标志物结果，所以成为入组的障碍。第二、 我们通过测量被调查者在以下方面的准确性和精确性来研究对学习伙伴的科学需求： 评估认知表现，预测认知能力下降，识别认知能力的细微变化， 并与参与者自己扮演这些角色的能力进行比较。 这些研究将为改善临床前AD试验方案设计提供有价值的数据， 研究者决定1）是否需要研究伙伴，2）谁有资格担任这一角色， 以及3）应如何保护参与者免受与其资格有关的潜在耻辱。