Chelsea G. Cox, 3206 Biological Sciences III, Irvine, CA 92697-4545, Email:
J Prev Alzheimers Dis. 2021;8(1):52-58. doi: 10.14283/jpad.2020.36.
Preclinical Alzheimer's disease clinical trials test candidate treatments in individuals with biomarker evidence but no cognitive impairment. Participants are required to co-enroll with a knowledgeable study partner, to whom biomarker information is disclosed.
We investigated whether reluctance to share biomarker results is associated with viewing the study partner requirement as a barrier to preclinical trial enrollment.
We developed a nine-item assessment on views toward the study partner requirement and performed in-person interviews based on a hypothetical clinical trial requiring biomarker testing and disclosure.
We conducted interviews on campus at the University of California, Irvine.
Two hundred cognitively unimpaired older adults recruited from the University of California, Irvine Consent-to-Contact Registry participated in the study.
We used logistic regression models, adjusting for potential confounders, to examine potential associations with viewing the study partner requirement as a barrier to preclinical trial enrollment.
Eighteen percent of participants reported strong agreement that the study partner requirement was a barrier to enrollment. Ten participants (5%) agreed at any level that they would be reluctant to share their biomarker result with a study partner. The estimated odds of viewing the study partner requirement as a barrier to enrollment were 26 times higher for these participants (OR=26.3, 95% CI 4.0, 172.3), compared to those who strongly disagreed that they would be reluctant to share their biomarker result. Overall, participants more frequently agreed with positive statements than negative statements about the study partner requirement, including 76% indicating they would want their study partner with them when they learned biomarker results.
This is one of the first studies to explore how potential preclinical Alzheimer's disease trial participants feel about sharing their personal biomarker information with a study partner. Most participants viewed the study partner as an asset to trial enrollment, including having a partner present during biomarker disclosure.
在有生物标志物证据但没有认知障碍的个体中进行的临床前阿尔茨海默病临床试验测试候选治疗方法。要求参与者与知情的研究伙伴共同注册，向其披露生物标志物信息。
我们调查了对分享生物标志物结果的不情愿是否与将研究伙伴要求视为临床前试验入组的障碍有关。
我们根据需要进行生物标志物测试和披露的假设临床试验，制定了一个关于对研究伙伴要求的看法的九项评估，并进行了面对面访谈。
我们在加利福尼亚大学欧文分校的校园内进行了访谈。
我们从加利福尼亚大学欧文分校同意接触登记处招募了 200 名认知正常的老年人参加了这项研究。
我们使用逻辑回归模型，根据潜在混杂因素进行调整，以检验与将研究伙伴要求视为临床前试验入组障碍之间的潜在关联。
18%的参与者报告强烈同意研究伙伴要求是入组的障碍。10 名参与者（5%）在任何程度上都同意他们不愿意与研究伙伴分享他们的生物标志物结果。与强烈不同意他们不愿意分享生物标志物结果的参与者相比，这些参与者认为研究伙伴要求是入组障碍的可能性要高 26 倍（OR=26.3，95%CI 4.0，172.3）。总体而言，参与者对研究伙伴要求的正面陈述比负面陈述更频繁地表示同意，包括 76%的人表示当他们得知生物标志物结果时，希望他们的研究伙伴与他们在一起。
这是首批探索潜在的临床前阿尔茨海默病试验参与者如何看待与研究伙伴分享他们的个人生物标志物信息的研究之一。大多数参与者认为研究伙伴是入组试验的资产，包括在披露生物标志物时让伴侣在场。
