A MULTIFACETED DIGITAL HEALTH PLATFORM TO ADVANCE ALZHEIMER'S DISEASE PATIENT MONITORING, SAFETY, CARE, AND RESEARCH.

项目摘要 阿尔茨海默病(AD)和AD相关痴呆症(ADRD)预计将影响到5000万美国人 2050年。2019年，1600多万美国人在为AD/ADRD患者提供无偿护理的同时苦苦挣扎 他们需要无耻辱的解决方案来帮助远程监控具有挑战性的AD/ADRD行为，如摔倒和 四处游荡。许多独立但相关的AD/ADRD临床试验是孤立的，需要患者志愿者和 他们的照顾者出差去面对面的约会。这对家庭来说是负担，增加了成本 进行研究，收集的数据往往不能代表日常生活。Amissa Inc.开发了一种耻辱- 免费的原型解决方案，可显著提高AD/ADRD患者的监控、安全性和护理水平 同时聚合高频数字生物标记物，以推进医学研究。几个竞争对手 已经开发了硬件设备来跟踪走失和/或摔倒的老年人，AD/ADRD 当痴呆患者表现出与痴呆相关的压力、焦虑、羞辱、负担和耻辱时 戴着这些“特殊”的设备。AD/ADRD护理者寻求“社会可接受的”改善健康的设备 和位置监控，安心省心，减少后顾之忧，提高患者安全和生活质量 亲人感到羞愧或尴尬。Amissa的原型软件应用程序，为广泛创建 可用的消费级智能手表，使家人能够远程监控亲人何时落入或 在家之外，帮助防止危险的流浪发作。我们最初的软件应用程序还发送 当亲人表现出异常行为(例如突发事件)时，向关键利益相关者发送紧急推送通知 可变心率的变化)。此第一阶段SBIR提案旨在开发一个被动地 并不引人注目地从AD/ADRD患者的智能手表中收集基于时间的行为和生物识别数据 改善护理的现实环境，同时建立一个高频率的云数据库 目前尚不存在AD/ADRD研究。AIM 1将开发一种由护理员设计的AD/ADRD患者监控 应用现成的消费类智能手表，并进行用户体验和用户界面测试 促进对迭代产品设计改进的反馈。利用来自Amissa护理者的Opt-In用户数据 监测应用，AIM 2将建立一个新的高频行为和生物特征云数据库，以 先进的AD/ADRD数字生物标记物研究能力，可预测患者跌倒。阿米萨项目 旨在通过更广泛的人口群体更快地收集多模式数据，以推进AD/ADRD 医学研究。此第一阶段SBIR通过提供单一、低成本、数字 改善AD/ADRD患者护理和安全的技术解决方案，同时减轻照顾者和 家人。此外，这项研究将提高分散进行的能力，降低成本 在真实环境中进行临床试验。在规模上，我们的目标是推进症状轨迹的预测 并使医生能够建议个性化的预防性治疗，以延迟发病或预防AD/ADRD。

Project Summary Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) are projected to affect 50 million Americans by 2050. In 2019, more than 16 million Americans struggled while providing unpaid care for people with AD/ADRD and they need stigma-free solutions to help remotely monitor challenging AD/ADRD behaviors like falling and wandering. Separate but related, many AD/ADRD clinical trials are siloed and require patient volunteers and their caregivers to travel to in-person appointments. This is burdensome for families, increases the cost to conduct studies, and data collected is often non-representative of daily life. Amissa Inc. has developed a stigma- free, prototype solution to significantly advance AD/ADRD patient monitoring, safety, and caregiving while simultaneously aggregating high-frequency digital biomarkers to advance medical research. Several competitors have developed hardware devices for tracking elderly individuals who wander and/or fall however, AD/ADRD patients express feelings of stress, anxiety, humiliation, burden, and stigma associated with dementia when wearing these “special” devices. AD/ADRD caregivers seek “socially-acceptable” devices that improve health and location monitoring, provide peace of mind, reduce worry, improve patient safety and quality of life without loved ones feeling shame or embarrassment. Amissa’s prototype software application, created for widely available, consumer-grade smartwatches, enables families to remotely monitor when loved ones fall inside or outside the home and help prevent dangerous wandering episodes. Our initial software application also sends emergency push notifications to key stakeholders when loved ones exhibit uncommon behaviors (e.g. sudden change in variable heart rate). This Phase I SBIR proposal is designed to develop a platform which passively and unobtrusively collects time-based behavioral and biometric data from AD/ADRD patient smartwatches in real-life settings to improve caregiving while also establishing a high-frequency cloud database where one does not currently exist for AD/ADRD research. Aim 1 will develop a caregiver-designed AD/ADRD patient monitoring application for off-the-shelf consumer smartwatches and conduct user-experience and user-interface testing to facilitate feedback for iterative product design improvement. Utilizing opt-in user data from Amissa’s caregiver monitoring application, Aim 2 will establish a novel high-frequency behavioral and biometric cloud database to advance AD/ADRD digital biomarker research capabilities to predict patient falls an wandering. Amissa’s project intends to enable faster collection of multimodal data via broader demographic populations to advance AD/ADRD medical research. This Phase I SBIR has the potential for high impact by providing a single, low-cost, digital technology solution to improve AD/ADRD patient care and safety while reducing stress for caregivers and families. Furthermore, this research will improve capabilities and reduce costs of conducting decentralized clinical trials in real-life environments. At scale, our goal is to advance the forecasting of symptom trajectories and enable physicians to suggest personalized preventative treatments to delay onset or prevent AD/ADRD.