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)

项目概要/摘要（30行） 我们很高兴提交这项技术和业务援助（TABA）资金， 行政补充我们正在进行的DP 2 SBIR：“神经运动游戏的预防 阿尔茨海默病和相关痴呆所致的衰退的治疗： 交互式身体和认知锻炼系统（iPACES v3）。我们正处于 收集临床试验数据，以复制和扩展我们的试点试验，这些试验表明认知 轻度认知障碍（MCI）的老年人在家中三个月后的福利 iPACES踏板游戏，使用平板电脑游戏搭配桌下踏板 （Anderson-Hanley等人，2018; Wall等人，2018）。与此同时，我们正在努力 预期的商业化努力，而在该领域的新发展，沿着进展 在我们的研发阶段，已经导致我们考虑各种下一步的选择。比如有 对数字医疗市场的关注日益增加，部分原因是COVID-19大流行 以及远程医疗服务的广泛采用。在选项中选择如何推出 第一个可指定的exergame导致我们许多困难的问题，一些已经暴露，通过 与NIA的常驻代表进行磋商。iPACES的独特之处在于它既针对 身体和认知过程和结果。目前还不清楚FDA可能会选择如何监管 混合使用，交互式干预，以及付款人如何应对 现有代码（例如，物理治疗，职业治疗，认知训练， 神经心理学评估，医生管理），或是否一个全新的代码 可能是正当的因此，我们要求为顾问提供资金，以帮助我们辨别 在相关的选择中，并为我们制定一个成功和可持续的行动方案， 随着临床试验数据在未来几个月的流入，预计将实现商业化。资金 本TABA补充文件将涵盖顾问意见，以指导FDA的监管工作， 更新我们的市场分析，考虑到远程医疗和严重的游戏计费编码扩展， 医疗保险市场的实施指南。此外，由于我们 在首次申请和SBIR裁决中，我们很高兴获得了最终的专利裁决 以及iPACES核心发明的独家使用许可。此外， 在我们的SBIR研发阶段，可能需要IP的几项进一步发展 保护（特别是与适应其他神经病理学有关的， 认知评估）。

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).