The MobileToolbox for Monitoring Cognitive Function

阿尔茨海默病(AD)和阿尔茨海默病相关疾病(ADRD)引起的痴呆症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衰退的能力是具有挑战性的。在一定程度上，我们受到缺乏敏感的成年人寿命评估工具的阻碍，这些工具可以在不同的研究环境和人群中轻松和广泛地部署。我们将通过开发、验证、规范和传播认知评估的MobileToolbox来解决这一限制，该工具箱可以通过智能手机远程管理20至85岁的成年人。我们将通过以下目标实现这一目标： 1.创建iOS和Android智能手机评估的MobileToolbox库。这些将来自我们与NIH工具箱、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(PROIS)的现有工作。该库将是开源的，可用于集成其他外部开发的测试。 2.开发和维护移动工具箱研究平台，这是一个支持临床研究人员，特别是AD/ADRD调查人员和软件开发人员将移动工具箱库动态、可定制地整合到研究研究中的软件平台。这将被开发为我们为支持2015年苹果ResearchKit发布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，管理研究和评估协议，并(酌情)接收、存储、汇总、分析和共享使用iOS和/或Android智能手机设备收集的数据。 3.开展心理测量活动，在一般人群和各种AD/ADRD研究样本中验证、规范和评估MobileToolbox的可靠性，以建立一般人口参考规范。 认知评估将在20-85岁的健康成年人中对照黄金标准进行验证。然后，这些衡量标准将被标准化，并根据年龄分层(20-85岁)、iOS与Android、全国样本与2020年美国人口普查(N=6800)计算出3个月、12个月和24个月的变化分数，包括性别、种族、民族、社会经济地位和教育水平。进一步的验证和纵向评估将在健康和临床样本中进行，包括MCI或AD和ADRD认知障碍的风险人群。一旦开发和验证，MobileToolbox研究平台中的评估就可以用于治疗试验，并最终在临床环境中用于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.