The MobileToolbox for Monitoring Cognitive Function

由于阿尔茨海默病（AD）和阿尔茨海默病相关疾病（ADRD）引起的痴呆的患病率随着年龄的增长而增加。然而，从AD和ADRD的最早阶段消除由于典型衰老引起的认知下降的能力是具有挑战性的。 在某种程度上，我们受到缺乏敏感的评估工具的阻碍，这些工具可以在不同的研究环境和人群中轻松广泛地部署。我们将通过开发，验证，规范和传播可通过智能手机远程管理的20至85岁成年人的认知评估的移动平台来解决这一限制。我们将通过以下目标实现这一目标： 1.创建基于iOS和Android智能手机的评估的移动数据库。这些将借鉴我们与NIH的现有工作，国际认知能力资源（ICAR），ResearchKit，ResearchStack，FaceName测试和患者报告结果测量信息系统（PROMIS）。该库将是开源的，可用于集成其他外部开发的测试。 2.开发和维护MobileData Research Platform，这是一个支持临床研究人员（尤其是AD/ADRD研究者）和软件开发人员将移动的Data Library动态、可定制地集成到研究中的软件平台。这将是我们为支持2015年苹果ResearchKit推出而构建的平台的扩展。该平台将支持研究人员贡献或选择评估，管理研究和评估方案，并接收，存储，汇总，分析和共享（如适用）使用iOS和/或Android智能手机设备收集的数据。 3.开展心理测量活动，以验证，规范和评估Mobiletransom在一般人群和各种AD/ADRD研究样本中的可靠性，以创建一般人群参考规范。 认知评估将在20-85岁的健康成年人中根据金标准测量进行验证。然后将这些指标进行归一化，并在年龄分层（20-85岁），iOS与Android，国家样本匹配2020年美国人口普查（N= 6，800）的性别，种族，民族，SES和教育水平中计算3个月，12个月和24个月的变化分数。将在健康和临床样本中进行额外的验证和纵向评价，包括MCI或AD和ADRD认知障碍风险人群。一旦开发和验证，移动研究平台内的评估可用于治疗试验，并最终在临床环境中治疗和预防阿尔茨海默病。

The prevalence of dementia due to Alzheimer’s Disease (AD) and Alzheimer’s Disease Related Disorders (ADRD) increases with advancing age. However, the ability to disambiguate cognitive decline due to typical aging from the earliest stages of AD and ADRD is challenging. In part, we are hampered by a lack of sensitive assessment tools across the adult lifespan that can be easily and widely deployed within diverse research settings and populations. We will address this limitation by developing, validating, norming, and disseminating a MobileToolbox of cognitive assessments that can be administered remotely via a smartphone in adults aged 20 to 85. We will accomplish this objective via the following aims: 1. Create the MobileToolbox Library of iOS and Android smart-phone based assessments. These will draw from our existing work with the NIH Toolbox, the International Cognitive Ability Resource (ICAR), ResearchKit, ResearchStack, the FaceName Test, and the Patient Reported Outcomes Measurement Information System (PROMIS). The library will be open source and available for integration of additional externally developed tests. 2. Develop and maintain the MobileToolbox Research Platform, a software platform to support clinical researchers, especially AD/ADRD investigators, and software developers in the dynamic, customizable integration of the Mobile Toolbox Library into research studies. This will be developed as an extension of the platform we built to support the 2015 launch of Apple’s ResearchKit. The Platform will support researchers to contribute or select assessments, to manage study and assessment protocols, and to receive, store, aggregate, analyze and share (as appropriate) data collected using iOS and/or Android smartphone devices. 3. Conduct psychometric activities to validate, norm and assess the reliability of the MobileToolbox in both the general population and various AD/ADRD research samples to create general population reference norms. The cognitive assessments will be validated against gold standard measures in healthy adults ages 20-85. The measures will then be normed and 3-month, 12-month and 24-month change scores calculated in an age stratified (20-85), iOS vs Android, national sample matching the 2020 US Census (N=6,800) for gender, race, ethnicity, SES and level of education. Additional validation and longitudinal evaluation will be conducted in healthy and clinical samples, including persons at risk for MCI or AD and ADRD cognitive impairments. Once developed and validated, the assessments within the MobileToolbox Research Platform can be used in treatment trials and ultimately within the clinical environment to treat and prevent Alzheimer’s Disease.