RETAIN: A digital therapeutic for Alzheimer's risk reduction

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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.