Virtual Reality Cognitive Therapy forAlzheimer's Disease

摘要 阿尔茨海默病（AD）和阿尔茨海默病相关痴呆（ADRD）目前影响超过5.8 2020年治疗和管理费用为3050亿美元， 如丧失独立性、生活质量低和疗养院要求。鉴于规模缩小 健康相关的生活质量，需要非侵入性定制的认知障碍（CI）靶向方法 帮助老年痴呆症患者势在必行有一个有效的个性化数字干预的显着需求， 在2019冠状病毒病大流行情况下，通过社交距离接触AD患者。 Claritytek建议开发一种以证据为基础的，非侵入性的，针对个人衰老认知的新工具。 改善AD/ADRD患者的生活质量。虚拟现实认知疗法（VRCT）利用四个- 多管齐下的方法：评估、教育、治疗和跟踪。VR是沉浸式的，将患者与周围环境隔离开来 干扰对任何人工智能干预都至关重要AD的认知干预应考虑认知功能的各个方面。 缺陷，特别是影响日常生活活动（ADL）和IADL（工具性ADL）的技能。VRCT旨在 治疗影响AD患者的IADL残疾。VRCT培训活动旨在模拟现实生活中的情况， 量身定制，以参与，适应，挑战，模拟逼真的CI生产场景中，他们发生的情况。 利用VRCT，通过游戏循环重复暴露于CI场景，逐渐训练患者在有用的 技能：医疗预约，服用药物，购物，记住名字，面孔和方向， 地方-保持和提高职能独立性。我们的系统将包括一个可选模式， 非面对面接触的异步在线治疗师咨询，在COVID-19隔离期间很有价值。 我们将扩大，适应，并建立在我们的团队先前成功的工作，为阿尔茨海默氏症患者与CI，排名 在国际数字健康竞赛中跻身世界前5名。 我们将与HealthPartners阿尔茨海默病研究神经科学中心的专家合作， 领导试验并帮助设计、开发和优化VRCT。我们将结合利益相关者的反馈， 以患者为中心的干预，针对与IADL相关的四个特定优先级“CI”，利用 数字治疗开发框架。为了指导该项目，我们将创建一个多学科专家焦点 组（EFG）。 在目标1中，我们将评估VRCT对36例轻度AD/ADRD患者的可行性、可用性和可接受性 到中度脑梗死我们将进行3项试验，每项试验均包含n=12的队列，共计n=36 参与者除了患者对治疗的反应外，评估的重点将是认知 耐受性，因为目标患者患有CI。每次试验的结果将在目标2中反复应用， 在下一次试验之前进行VRCT，产生最可接受的CI干预。 在目标2中，我们将根据患者的反馈迭代地重新设计、开发、单元测试和优化VRCT， 试验和EFG分析。我们希望建立VRCT将是可行的，可用的，可接受的， 可用性量表的成功率为90%，用户满意度为80%。

ABSTRACT Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD) currently affect more than 5.8 million Americans, costing $305 billion for treatment and management in 2020 and causing poor outcomes such as loss of independence, low quality of life, and nursing home requirements. Given the scale of diminished health-related quality of life, the need for non-invasive customizable cognitive impairment (CI) targeting methods to assist AD patients is imperative. There is a significant need for effective individualized digital interventions for AD patients accessible with social distancing in the COVID-19 pandemic situation. Claritytek proposes to develop an evidence-based, non-invasive, novel tool targeting individual aging cognitive deficits to improve AD/ADRD patients' quality of life. Virtual Reality Cognitive Therapy (VRCT) utilizes a four- pronged approach: Assess, Educate, Treat, and Track. VR is immersive, isolating the patient from surrounding distractions -- crucial for any CI intervention. Cognitive Interventions for AD should consider all facets of cognitive deficits, especially skills impacting activities of daily living (ADL) and IADL (instrumental ADL). VRCT aims to treat IADL disabilities impacting AD patients. VRCT training activities are designed to imitate real-life situations, tailored to engage, adapt, challenge, simulating lifelike CI-producing scenarios in contexts where they occur. Utilizing VRCT, repeated exposures to CI scenarios through game loops to gradually train patients in useful skills: medical appointments, taking medications, shopping, and remembering names, faces, and directions to places – to preserve and improve functional independence. Our system will include an optional mode for asynchronous online therapist consultations without face-to-face contact, valuable during COVID-19 isolations. We will expand, adapt, and build on our team’s prior successful work for Alzheimer’s patients with CI, ranked among the top 5 innovations in the world at an international digital health competition. We will partner with specialists at the HealthPartners Neuroscience Center for Alzheimer’s Research to lead the trial and help design, develop, and optimize VRCT. We will incorporate stakeholder feedback to create a patient-centric intervention targeting four specific prioritized "CI" related to IADL, utilizing guidelines of the digital therapy development frameworks. To guide the project, we will create a multidisciplinary Expert Focus Group (EFG). In Aim 1, we will evaluate the feasibility, usability, and acceptability of VRCT on 36 AD/ADRD patients with mild to moderate CI over seven weeks. We will conduct three trials, each trial with a cohort of n=12, total of n=36 participants. In addition to the patient’s responses to the therapy, a focus of the evaluation will be cognitive tolerability, as the target patients have CI. The results from each trial will be applied iteratively in Aim 2 to revise the VRCT before the next trial, producing the most acceptable CI intervention. In Aim 2, we will iteratively redesign, develop, unit test, and optimize VRCT based on patients’ feedback from the trials and EFG analysis. We expect to establish that VRCT will be feasible, usable, and acceptable with a Usability Scale success rate of 90%, and user satisfaction of 80%.