Neuro-exergaming for the prevention and remediation of decline due to Alzheimer's disease and related dementias: A clinical trial of the interactive Physical and Cognitive Exercise System (iPACES v3)

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Project Summary/Abstract (30 lines) We are pleased to submit this technical and business assistance (TABA) funding as an administrative supplement to our on-going DP2 SBIR: “Neuro-exergaming for the prevention and remediation of decline due to Alzheimer's disease and related dementias: A clinical trial of the interactive Physical and Cognitive Exercise System (iPACES v3).” We are in the midst of collecting clinical trial data to replicate and extend our pilot trials which suggested cognitive benefits for older adults with mild cognitive impairment (MCI) after three months of in-home iPACES pedal-to-play, using a tablet-based game paired with an under-table pedaler (Anderson-Hanley et al., 2018; Wall et al, 2018). Simultaneously, we are working toward anticipated commercialization efforts, while new developments in the field, along with progress in our R&D phase, have led us to consider a variety of next-step options. For example, there is increasing attention to the digital health market, partly spurred on by the COVID-19 pandemic and widespread adoption of telehealth services. Choosing among options for how to roll out the first prescribable exergame leads us to many difficult questions, some already exposed through consultations with NIA's entrepreneurs-in-residence. iPACES is unique in that it targets both physical and cognitive processes and outcomes. It is unclear how FDA might choose to regulate a mixed use, interactive intervention and furthermore how payors might respond to billing under existing codes (e.g., for physical therapy, occupational therapy, cognitive training, neuropsychological assessment, physician management), or whether an entirely new code might be warranted. We are thus requesting funding for consultant advisors to help us discern among relevant options and chart a successful and sustainable course of action for our anticipated commercialization as clinical trial data flows in over the coming months. Funding from this TABA supplement would cover consultant input to guide regulatory pursuits with FDA, update our market analysis given telehealth and serious games billable coding expansions, and guidance for implementation in the healthcare insurance marketplace. Furthermore, since our initial application and SBIR award, we are pleased to have secured both the final patent ruling and exclusive license for use of the core iPACES invention. Additionally, there have been several further developments during our R&D phase of this SBIR that may warrant IP protections (esp related to adaptations for other neuropathologies and integrated and gamified cognitive assessments).