Developing a digital and generative AI tool to improve participation in AD/ADRD trials

This proposal responds to an acute challenge currently underserved by technology; the need to leverage novel approaches to develop cost-effective and responsive digital, mobile, website, and artificial intelligence (AI) tools to encourage participation in Alzheimer disease and related dementias (ADRD) clinical trials. With ADRD cases expected to double by 2060, efforts to ensure adequate participation in ADRD clinical trials is paramount to ensuring successful biomedical advances and drug development. Despite ongoing efforts to improve ADRD outcomes and clinical trial participation, no digital solution exists which has been purposefully designed and co-developed in partnership with patients at higher-risk of ADRD or with informal caregivers of ADRD patients critical in addressing challenges associated with trial participation. In response, this project utilizes approaches in digital tool development, AI, qualitative interviews and small group discussions, and use of co-design workshops to develop a multi-modal digital tool incorporating mobile, website, and AI chatbot features that will improve the education, recruitment, and enrollment of older adults in ADRD clinical trials. This will be accomplished by developing a trial matching algorithm specific to ADRD trials, conducting interviews with older adults and ADRD patient caregivers to identify specific challenges to participation, and facilitating a series of co-design sessions to develop digital tools designed to encourage trial participation among all older adults responsive to these challenges. It has the following aims: Aim 1: Develop a dedicated and up-to-date clinical trial matching algorithm for ADRD trials that will be further iterated on, refined, and incorporated into the MVP digital tool (M1: Create an ADRD trial matching algorithm within 1-2 months of project start); Aim 2: Conduct in-depth interviews and small group discussions with older adults and ADRD caregivers to identify factors related to clinical trial participation and use of digital, mobile, website, and AI technology, which will be used to inform digital tool features and the matching algorithm (M2: Complete in-depth interviews with 30 older adults and 30 caregivers by months 3-4); Aim 3: Co-design an MVP digital tool incorporating mobile, website, and chatbot modalities with older adults and ADRD caregivers and conduct business hypothesis testing (M3: Complete co-design sessions, develop and demo two versions of the MVP to at least 3 potential customers/strategic partners by the end of month 6) This is a significant opportunity to address increasing rates of ADRD among the growing aging population with the use of different digital health technologies. This project will lead to the co-design and development of user-centric tools to improve clinical trial outreach and participation of all older adult populations while also enabling more precision-based recruitment strategies to advance treatment and biomedical innovation for ADRD. Project Number: 1R43AG091831-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Institute on Aging (NIA) | Principal Investigator: Timothy Mackey | Institution: S-3 RESEARCH, LLC, SAN DIEGO, CA | Award Amount: $499,778 | Activity Code: R43 | Study Section: Special Emphasis Panel[ZAG1 ZIJ-5 (M2)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11250476