Aims:

Alzheimer’s disease (AD) is a gradually progressive neurodegenerative disease that ultimately results in total loss of cognitive and functional independence in older adults. This study aimed to examine the safety and tolerability of APOE disclosure in community-dwelling, cognitively normal (CN) older adults from the Butler Alzheimer’s Prevention Registry (BAPR), and to determine whether APOE disclosure impacted participant’s decisions to participate in AD clinical research.

Methods:

186 (N = 106 ∊4 non-carriers, 80 ∊4 carriers) CN older adults aged 58-78 from the BAPR completed 2 visits: one for psychological readiness screening and genotyping and one for APOE disclosure. Online follow-ups were completed 3 days, 6 weeks, and 6 months post-disclosure. Primary outcomes were scores on self-report measures of depression, anxiety, impact of events, and perceived risk of AD, along with enrollment in AD clinical trials.

Results:

∊4 carriers and non-carriers did not differ significantly on measures of depression, anxiety, or suicidal ideation over the 6-month follow-up period. ∊4 carriers reported higher impact of disclosure than non-carriers immediately after disclosure, but both groups’ scores on impact of events measures remained sub-clinical. ∊4 carriers and non-carriers were equally likely to participate in AD research after disclosure, with genotype-dependent differences in type of clinical trial enrollment.

Conclusions:

APOE genotyping and disclosure was safe and well tolerated in a group of CN, community-dwelling older adults, who were pre-screened after volunteering for AD research through BAPR. Implications for the inclusion of APOE genotyping and disclosure at AD clinical trial sites are discussed.

中文翻译：

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来自 Butler 阿尔茨海默病预防登记处的认知正常志愿者中 APOE 基因分型和披露的安全性和耐受性

目标：

阿尔茨海默病 (AD) 是一种逐渐进展的神经退行性疾病，最终导致老年人完全丧失认知和功能独立性。本研究旨在检查来自 Butler 阿尔茨海默病预防登记 (BAPR) 的社区居住、认知正常 (CN) 老年人中APOE披露的安全性和耐受性，并确定APOE披露是否影响参与者参与 AD 临床研究的决定。

方法：

186 (N = 106 ∊4 非携带者，80 ∊4 携带者) 来自 BAPR 的 58-78 岁的 CN 老年人完成了 2 次访问：1 次用于心理准备筛查和基因分型，1 次用于APOE披露。在线随访在披露后 3 天、6 周和 6 个月完成。主要结果是抑郁、焦虑、事件影响和 AD 感知风险的自我报告测量得分，以及参与 AD 临床试验。

结果：

∊4 携带者和非携带者在 6 个月的随访期间在抑郁、焦虑或自杀意念方面没有显着差异。∊4 携带者在披露后立即报告了比非携带者更高的披露影响，但两组在事件影响测量中的得分仍处于亚临床水平。∊4 携带者和非携带者在披露后参与 AD 研究的可能性相同，临床试验注册类型存在基因型依赖性差异。

结论：

APOE基因分型和披露在一组 CN、社区居住的老年人中是安全且耐受性良好的，他们在自愿通过 BAPR 进行 AD 研究后进行了预筛选。讨论了在 AD 临床试验地点纳入APOE基因分型和披露的意义。