Optimization of an at-home continuous multi-domain monitoring and assessment system to improve Alzheimer's and related disorders clinical trials

摘要/摘要：阿尔茨海默病和阿尔茨海默病相关痴呆(AD/ADRD) 影响我们庞大且不断增长的老龄化人口。据估计，有580万65岁及以上的美国人 患有AD，预计到2050年，这一数字将达到1380万。年迈的非裔美国人和拉丁裔 人口受AD/ADRD的打击尤其严重，农村社区也是如此，因为无法获得临床 试验和医疗护理。一系列的症状与这些疾病和每个患者的 进展是独一无二的，在临床上也有很大的差异。在临床试验期间，当纵向研究 在几个月到几年的时间里，患者的大部分生活方式和功能没有得到监测，因为他们处于 与他们的伴侣或单独在家，不与专业提供商联系。不频繁的数据收集 依赖于患者准确检索自上次体检以来生活的相关细节的能力， 由于自我报告和回忆的挑战，这本身就是不准确或不完整的。因此，有一个 临床试验中对更频繁、准确和完整的患者监控的迫切需求，特别是在 目前服务不足的社区。为了满足这一需求，Life Analytics正在进一步发展 一个家庭监控平台，称为生活分析监控平台(LAMP)。LAMP基于 美国国立卫生研究院和退伍军人事务部资助了合作老龄化技术研究(CART)倡议系统。购物车是一种 端到端(硬件和软件)平台，提供老年病的高频监测 通过测量真实世界的数据来进步，从而向学术人员提供数字远程评估模型 研究社区。购物车系统是由我们的研究团队在 俄勒冈州老龄化与科技中心(ORCATECH)。通过这些努力，一个高度实用的 支持和部署用于学术研究的这些系统的通用基础设施 已经成立了。到目前为止，ORCATECH/CART平台已经在全球1000多个家庭中安装 目前正在收集数据，并将数据传输回ORCATECH服务器进行分析。 此外，洛杉矶团队通过发布表明，高频家庭监控数据允许 临床研究将以较少的患者适当提供动力。因此，该平台具有很高的潜力 改变临床试验的进行方式--如果这样的系统能够广泛传播的话。这个法斯塔克 将协助改进现有ORCATECH/CART所需的关键研究和开发 通过以下目标将LAMP平台转化为商业化LAMP平台：SA 1(第一阶段)：迁移 ORCATECH/CART系统，提供安全且可扩展的云操作。SA 2(第二阶段)：LAMP的优化 数据传输、存储和分析。SA 3(阶段II)：使用Alpha演示灯的可用性-使用 第三方，非现场位置。

Summary/Abstract: Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) adversely impact our large and growing aging population. An estimated 5.8 million American’s 65 years and older are suffering from AD, with that number projected to hit 13.8 million by 2050. Aging African American and Latinx populations are particularly hard-hit by AD/ADRD, as are rural communities due to lack of access to clinical trials and medical care. A broad range of symptoms are associated with these diseases and each patient’s progression is unique and clinically quite variable. During a clinical trial, when longitudinal studies are conducted over months to years, much of the patient’s lifestyle and function goes unmonitored as they are at home with their partner or alone and without contact with professional providers. Infrequent data collection relies on the ability of patients to accurately retrieve relevant details about their lives since the last checkup, which is inherently inaccurate or incomplete due to the challenges of self-report and recall. Thus, there is a critical need in clinical trials for more frequent, accurate, and complete patient monitoring especially in communities that are currently underserved. To meet this need, Life Analytics is furthering the development of an at-home monitoring platform, called Life Analytics Monitoring Platform (LAMP). LAMP is based off of the NIH and VA funded Collaborative Aging Research Using Technology (CART) initiative system. CART is an end-to-end (hardware and software) platform, which provides high-frequency monitoring of geriatric disease progression by measuring real-world data, thus providing a digital remote assessment model to the academic research community. The CART system was built by, and has been further developed by, our research team in the Oregon Center for Aging and Technology (ORCATECH). Through these efforts a highly functional generalizable infrastructure for support and deployment of these systems for academic research has been established. To date, the ORCATECH/CART platform has been installed in more than 1000 homes across North America and is currently collecting and transmitting data back to ORCATECH servers for analysis. Additionally, the LA team has shown through publication that high-frequency in-home monitoring data allows clinical studies to be appropriately powered with fewer patients. Therefore, this platform has the high potential to change the way that clinical trials are conducted – if such a system can broadly disseminated. This Fastrack will assist with the critical research and development required to improve the existing ORCATECH/CART platform into the commercialized LAMP platform through the following Aims: SA 1 (Phase I): Migrate ORCATECH/CART system to secure and scalable cloud operability. SA 2 (Phase II): Optimization of LAMP for data transfer, storage, and analysis. SA 3 (Phase II): Demonstrate LAMP usability with Alpha-testing with a third party, off-site location.