# 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)

> **NIH NIH R44** · IPACES, LLC · 2022 · $50,000

## Abstract

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).

## Key facts

- **NIH application ID:** 10533109
- **Project number:** 3R44AG071063-02S2
- **Recipient organization:** IPACES, LLC
- **Principal Investigator:** PAUL J ARCIERO
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $50,000
- **Award type:** 3
- **Project period:** 2020-09-30 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10533109

## Citation

> US National Institutes of Health, RePORTER application 10533109, 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) (3R44AG071063-02S2). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10533109. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*