Multisystem risk profile of older adults to predict cognitive function and impairment

摘要/摘要 此补充建议是针对PA-18-591，NOT-AG-20-022，NIA的可用性 2019年冠状病毒病行政补充和修订补充(新冠肺炎)。父辈 R03研究(AG063328)是为了对多系统风险因素进行试点、系统的调查 65-89岁老年人AD/ADRD结局的(MRF)。这项研究包括横断面 (目标1，N=150)和预期(目标2，N=50)目标。对于目标2，对50名老年人进行了前瞻性调查 有轻度认知障碍和无轻度认知障碍的个体将在大约10-12个时间点进行检查 相隔几个月。新冠肺炎疫情和全州范围的隔离命令已经并正在产生重大影响 对正在进行的项目的影响，使所有与面对面项目有关的活动自 3月的第一周，积极的登记和亲自收集数据的工作已经停止。目前，有许多 符合条件的研究参与者，由加州大学圣迭戈分校记忆诊所推荐，并提供可用的神经心理测试数据 (“结果”)，不能接受对MRF的面对面评估(“风险因素”)。此外，持续时间 目前尚不清楚暂停对人体进行现场测试的可能性，特别是在充分谨慎的情况下 适用于有既往疾病(如高血压、糖尿病等)的老年参与者这一增长 新冠肺炎的发病和死亡风险。招聘和正式注册时间为10-12个月 没有明确的预测测试时间表的前瞻性研究对于高辍学可能性是远远无效的 以及利息的损失。因此，我们请求补充资金，以启动中期预测的远程数据收集以及 与新冠肺炎相关的因素，假设会像我们一样及时地影响许多MRF和研究结果 都有能力。我们建议通过以下方式收集参与者报告的指导数据和参与者收集的MRF数据 在“远程学习-访问”期间采用在线、邮件和电话方式。将收集所有五个MRF域测量结果 除了更复杂的血液动力学测量外，还可以进行远程检查。一些基本的血流动力学数据将 由自己或家庭/家庭成员使用研究提供的血压和氧气监测仪收集，同时 通过电话或视频提供的说明。大部分的心理社会功能和一些日常功能 如有可能，将通过在线和/或邮寄表格来衡量变量。这将使及时登记 确定的合格参与者及其与(目标1)和可预测性的关联的中期评估框架 (目标2)获取现有的认知/ADRD数据。新冠肺炎相关隔离应激/孤独感的影响 关于认知功能和AD/ADRD风险的创伤后应激障碍症状以及关键的MRF是至关重要的，应考虑为 协变量，这也将通过这一及时补充来实现。这样做的主要目的是 补充是为了适应新冠肺炎相关状态的人体主体检测程序，以及 这一补充不是为了改变，而是为了确保成功实现最初的目标。

Summary/Abstract This supplement proposal is in response to PA-18-591 with NOT-AG-20-022, NIA Availability of Administrative Supplements and Revision Supplements on Coronavirus Disease 2019 (COVID-19). The parent R03 study (AG063328) is to conduct a pilot, systematic investigation to scrutinize multi-system risk factors (MRFs) for AD/ADRD outcomes among older adults aged 65 – 89 years. The study includes cross-sectional (Aim 1, N= 150) and prospective (Aim 2, N= 50) aims. For Aim 2, a prospective investigation of 50 older individuals with and without mild cognitive impairment will be performed at two time points about 10 - 12 months apart. COVID-19 pandemic and the statewide quarantine order have had and are having a significant impact on the ongoing project such that all in-person project-related activities had been suspended since the first week of March, and active enrollment and in-person data collection had been halted. Currently, many eligible study participants, referred by the UCSD memory clinic with available neuropsychological test data (“outcomes”), cannot undergo an in-person assessment of the MRFs (“risk factors”). Furthermore, the duration of suspended on-site testing of human subjects is currently unclear, especially when abundant caution should be taken for elderly participants with pre-existing conditions (e.g., hypertension, diabetes, etc.) that increase the morbidity and mortality risk of COVID-19. Recruitment and formal enrollment into a 10 - 12 month prospective study without definitive projected testing timeline is far from effective for high potential for drop-out and loss of interest. Thus, we request supplement funds to initiate remote data collection of MRFs as well as COVID-19-related factors that are hypothesized to affect many MRFs and the study outcomes as timely as we are able. We propose to collect guided participant-reported and participant-collected data of MRFs through online, mail and phone methods during a “tele-study-visit”. All five MRF domain measurements will be collected remotely except for more sophisticated hemodynamics measures. A number of basic hemodynamic data will be collected by self or a household/family member using a study-provided BP and O2 monitors while instructions provided over the phone or video. The majority of psychosocial and some daily functioning variables will be measured via online when possible and/or mailed forms. This will enable timely enrollment of identified eligible participants and assessment of MRFs in their associations with (Aim 1) and predictability (Aim 2) for available cognition/ADRD data. The effects of COVID-19-related isolation stress/loneliness and PTSD symptoms on cognitive functioning and AD/ADRD risk as well as key MRFs are critical to consider as covariates, which will be also achieved through this timely supplement. The primary purpose of this supplement is to adapt to the COVID-19-related state of human subject testing procedures, and the aims of this supplement are not to change but to ensure the successful achievement of the original aims.