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)

用于预防和治疗阿尔茨海默病和相关痴呆症引起的衰退的神经运动游戏：交互式身体和认知运动系统 (iPACES v3) 的临床试验

• 批准号: 10533109
• 负责人: PAUL J ARCIERO
• 金额: $ 5万
• 依托单位: IPACES, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10533109
• 关键词: Administrative Supplement; Adoption; Alzheimer' s disease related dementia; Attention; Award; Businesses; COVID-19 pandemic; Clinical Trials; Code; Cognitive; Consultations; Data; Development; Elderly; Exercise; FDA approved; Funding; Healthcare; Home; Insurance; Intellectual Property; Intervention; Legal patent; Licensing; Light; Neuropsychology; Occupational Therapy; Outcome; Phase; Physical therapy; Physicians; Play; Prevention; Publishing; Secure; Services; Small Business Innovation Research Grant; System; Tablets; Update; Video Games; base; cognitive benefits; cognitive process; cognitive testing; cognitive training; commercialization; digital health; exergame; invention; mild cognitive impairment; neuropathology; physical process; pilot trial; remediation; research and development; residence; telehealth

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).

项目摘要/摘要（30行） 我们很高兴将此技术和业务援助（TABA）资金作为 我们正在进行的DP2 SBIR的管理补充：“预防神经外观 并修复由于阿尔茨海默氏病和相关痴呆症引起的下降：一项临床试验 交互式物理和认知运动系统（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验试验，该试验表明认知 三个月后，对患有轻度认知障碍（MCI）的老年人的好处 使用基于平板电脑的游戏配搭配台式踏板，iPaces踏板到游戏 （Anderson-Hanley等，2018; Wall等，2018）。同时，我们正在努力 预期的商业化工作，而该领域的新发展以及进步 在我们的研发阶段，使我们考虑了各种下一步的选择。例如，有 越来越多地关注数字健康市场，部分由COVID-19大流行促进 并广泛采用远程医疗服务。选择如何推出 首先可开处方的Exergame导致我们遇到许多困难的问题，有些已经暴露 与NIA驻地企业家进行磋商。 ipaces是独一无二的 身体和认知过程和结果。目前尚不清楚FDA如何选择调节 混合用途，互动干预，此外，付款人如何应对计费 现有的代码（例如，用于物理治疗，占领疗法，认知培训， 神经心理学评估，身体管理），或者是全新的代码 可能有必要。因此，我们要求为顾问顾问提供资金，以帮助我们辨别 在相关选择中，为我们的 预期商业化是在未来几个月内临床试验数据流动。资金 从本taba补充剂中，将涵盖顾问的意见，以指导与FDA的监管追求， 鉴于远程医疗和严肃的游戏可计费编码扩展，更新我们的市场分析，以及 医疗保险市场实施指南。此外，自我们以来 初步申请和SBIR奖，我们很高兴获得了最终专利裁决 以及使用核心IPACE事故的独家许可证。此外，还有 在我们的SBIR研发阶段的进一步发展可能需要IP 保护（EMP与其他神经病理学的适应以及集成和赌博有关 认知评估）。