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

摘要/摘要 本补充提案是对PA-18-591和NOT-AG-20-022 NIA可用性的回应， 关于2019冠状病毒病（COVID-19）的行政补充和修订补充。母 R 03研究（AG 063328）旨在进行一项初步、系统性研究，以审查多系统风险因素 （MRF）用于65 - 89岁老年人的AD/ADRD结局。该研究包括横截面 (Aim 1，N= 150）和前瞻性（目标2，N= 50）目标。对于目标2，对50名老年人进行了前瞻性研究， 具有和不具有轻度认知损害的个体将在约10 - 12小时的两个时间点进行 相隔数月COVID-19大流行和全州隔离令已经并正在产生重大影响， 对正在进行的项目的影响，自2010年以来，所有与项目有关的现场活动都已暂停。 3月的第一周，积极的登记和面对面的数据收集已经停止。目前许多 合格的研究参与者，由UCSD记忆诊所提供可用的神经心理学测试数据 （“结果”），不能进行MRF的亲自评估（“风险因素”）。此外，持续时间 目前尚不清楚暂停对人类受试者进行现场测试的可能性，特别是在应 适用于有既往病史的老年参与者（例如，高血压、糖尿病等）增加 COVID-19的发病和死亡风险。招聘和正式入职分为10 - 12个月 没有明确的预计测试时间轴的前瞻性研究对于高脱落可能性来说是远远无效的 和失去兴趣。因此，我们要求补充资金，以启动监测报告框架的远程数据收集， 假设COVID-19相关因素会影响许多MRF和研究结果， 都有能力。我们建议通过以下方式收集引导参与者报告和参与者收集的MRF数据 在线、邮件和电话方式。将收集所有五个MRF域测量值 除了更复杂的血液动力学测量外，一些基本的血液动力学数据将 由自己或家庭/家庭成员使用研究提供的BP和O2监测仪采集， 通过电话或视频提供的说明。大多数的社会心理和一些日常功能 变量将通过在线（如可能）和/或邮寄表格进行测量。这将有助于及时登记 确定合格的参与者，评估衡量指标框架与目标1和可预测性的关系 (Aim 2）对于可用的认知/ADRD数据。与COVID-19相关的隔离压力/孤独感和 PTSD症状对认知功能和AD/ADRD风险以及关键MRF的影响至关重要， 协变量，这也将通过及时补充实现。这个的主要目的 补充是为了适应与COVID-19相关的人类受试者检测程序的状态，目的是 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.