Flourish All: Women's Integrated Stress Reduction for Alzheimer's Risk Prevention Using Digital Tools and Biomarker Monitoring

One Health Studio Llc, San Francisco CA

Investigators

Abstract

Alzheimer’s disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD) disproportionately affect women, who account for two-thirds of all AD patients. One critical but underexplored factor contributing to this disparity is menopause, a life stage experienced by half of the world’s population. Hormonal changes during menopause, particularly the decline in estrogen, are linked to increased neuroinflammation, a key driver of ADRD risk. Postmenopausal women also face heightened vulnerability to stress-related disorders, which further exacerbate inflammation and cognitive decline. Addressing these factors during menopause offers a transformative opportunity to reduce ADRD risk. with stress and inflammation recognized as key risk factors influencing its onset. This project seeks to address this critical gap through the development and evaluation of the Flourish All platform, an AI-enabled digital health solution aimed at reducing ADRD risk by managing stress and promoting healthy behaviors in midlife women. The study will be conducted in two phases: Phase I (Pilot Study): This phase will focus on usability, acceptability, and feasibility testing with 40 participants aged 50–70 who exhibit moderate to high perceived stress. Over a 12-week period, participants will interact with the Flourish All platform, which integrates an AI chatbot, wearable devices, and at-home biomarker collection kits. Outcomes will include participant engagement (e.g., ≥3 chatbot interactions per week), usability (>80% of participants rating the platform as easy to use), and feasibility (>80% provision of usable biomarker and wearable data). Insights from this pilot will inform iterative refinements to enhance the platform’s usability and functionality in preparation for larger-scale trials. Phase II (Randomized Controlled Trial): Building on the pilot findings, a 12-week RCT will be conducted with 120 participants, randomized into intervention and waitlist control groups. Participants in the intervention group will engage with the Flourish All platform to receive personalized, AI-driven recommendations targeting stress reduction, physical activity, and sleep quality. Data collection will occur at baseline, immediately post-intervention, and at 3- and 6-month follow-ups. The efficacy of the platform will be assessed through primary outcomes, including reductions in perceived stress (PSS scores) and inflammation biomarkers (CRP, IL-6). Secondary outcomes include improved sleep quality, cognitive function (MMSE, ADAS-Cog, ECog), and physical activity. Longitudinal data will enable the development of predictive AI models linking stress reduction to changes in AD risk markers and cognitive performance.