RETAIN: A digital therapeutic for Alzheimer's risk reduction

阿尔茨海默氏症是美国最昂贵的疾病。它在大脑中静静地开始了几十年 在记忆丧失之前估计有4600万美国人受到第一个症状前阶段的影响 老年痴呆症（AD）这一阶段是解决风险因素的机会之窗， 延缓痴呆症的发展不幸的是，大多数人没有意识到生活方式的改变， 可以显著延缓认知能力的下降。此外，很少有医生专门从事AD风险 大多数AD患者生活在低收入社区，医疗服务有限。 几项随机试验发现，多领域干预可以维持认知。审判导致 我们的研究小组的两名成员表明，个性化的生活方式干预可以显着减少 AD风险和改善认知。为了在这项工作的基础上，RETAIN Health，Inc开发了一个跨平台的"移动的- 第一次"应用于AD风险降低。RETAIN是一种数字治疗，旨在评估 并应用行为矫正技术来提供基于证据、个性化 建议.我们的系统在饮食、体育锻炼、睡眠、社交等方面促进行为改变。 参与，认知参与，血管风险因素（例如，血压），肥胖，戒烟， 和压力管理RETAIN使用双向SMS文本消息来创建虚拟对话。作为 96%的美国人拥有手机，自动文本通信可以经济有效地为缺乏手机的人提供服务。 大规模地获得护理。重要的是，RETAIN建立了我们之前7年的研究，使用基于网络的 与学术界合作开展教育，建立实质性基础。 我们的目标是通过定性和定量的用户体验来改善我们软件的用户体验。 体验测试然后，我们将使用经验证的 风险指数我们还将探索改善认知和生活质量的有效性。然后我们将评估 风险降低干预措施给用户带来的相关成本，并评估用户满意度。我们会进行 一项为期6个月、基于网络的三组随机对照试验，纳入860名有AD风险的受试者。正如 完成我们以前的研究，我们将使用有针对性的互联网广告，以迅速和成本效益的招聘 一个多样化的群体第1组将包括个性化的、基于网络的AD风险因素教育以及定期的 个性化的双向SMS文本通信。第2组将包括基于网络的个性化AD风险因素 教育没有个性化的短信文本。第3组（对照）将包括广义AD教育，包括 统计、公共政策和宣传，沿着关于这些主题的定期短信交流。 该项目的成功实施将产生第一个自动化数字解决方案， 多领域的个体化管理，为人们在风险的AD。这也将导致一个产品准备 市场和解决国家阿尔茨海默病项目法案的目标，到2025年预防和有效治疗AD。

Alzheimer's is the most expensive disease in the United States. It starts silently in the brain decades before memory loss begins. An estimated 46 million Americans are affected by the first pre-symptomatic phase of Alzheimer’s disease (AD). This stage represents a window of opportunity to address risk factors which can delay progression to dementia. Unfortunately, the majority of this population is unaware that lifestyle changes can significantly delay cognitive decline. In addition, few have access to physicians specializing in AD risk reduction and most people with AD live in low-income communities with limited healthcare access. Several randomized trials have found that multi-domain interventions can maintain cognition. A trial led by two members of our study team showed that individualized lifestyle interventions can significantly reduce AD risk and improve cognition. To build on this work, RETAIN Health, Inc developed a cross platform “mobile- first” application for AD risk reduction. RETAIN is a digital therapeutic designed to assess the risk of an individual and apply behavioral modification techniques to deliver evidence-based, personalized recommendations. Our system promotes behavior change in the areas of diet, physical exercise, sleep, social engagement, cognitive engagement, vascular risk factors (e.g., blood pressure), obesity, smoking cessation, and stress management. RETAIN uses bi-directional SMS text messaging to create a virtual conversation. As 96% of Americans own cell phones, automated text communication can cost-effectively serve people who lack access to care on a large scale. Importantly, RETAIN builds off 7 years of our prior research using web-based education in collaboration with academia, establishing a substantive foundation. We aim to improve the user experience of our software through both qualitative and quantitative user experience testing. We will then evaluate whether RETAIN is effective in reducing AD risk using a validated risk index. We will also explore effectiveness in improving cognition and quality of life. We will then assess the associated costs to the user of the risk reduction interventions and evaluate user satisfaction. We will conduct a six-month, web-based, three-arm randomized controlled trial of 860 subjects at risk for AD. As was accomplished in our prior studies, we will use targeted internet advertising to rapidly and cost-effectively recruit a diverse cohort. Arm 1 will include personalized, web-based AD risk factor education plus regular personalized bi-directional SMS text communication. Arm 2 will include personalized web-based AD risk factor education without personalized SMS text. Arm 3 (control) will include generalized AD education covering statistics, public policy, and caregiving, along with regular SMS text communication about these topics. Successful implementation of this project will result in the first automated digital solution to provide multi-domain individualized management for people at risk for AD. It will also result in a product ready for market and address goals of the National Alzheimer's Project Act to prevent and effectively treat AD by 2025.