Smartphone phenotype collection for diagnostic screening of mild cognitive impairment

项目摘要 在这个第二阶段SBIR项目中，Parabon NanoLabs将完成开发，验证和 CTX的商业化，这是一种革命性的基于智能手机和平板电脑的认知测试 用于收集和分析认知表现（“表型”）测量的平台。 传统上，认知评估在诊所中使用简单的调查来进行， 只评估认知的某些方面或昂贵的单一用途设备，如眼动追踪 站的这种测试缺乏检测微妙的早期变化所需的频率和精度， 提示轻度认知障碍（MCI）或早期症状性痴呆的发作。相反地， CTX将充分利用移动的传感器（例如，音频、视频、触摸屏和运动）， 随时随地进行深入的认知测试。定期使用CTX将允许更清晰的 每个用户的认知能力的图片出现，使早期发现微妙的变化。CTX 并不是为了取代神经科医生，而是为了扩大他们的范围， 广泛筛查，以改善疾病检测和患者监测。远景目标 CTX的目的是让老年人更有效地监测和管理他们的认知健康， 为患者及其临床医生提供即将发生痴呆症的症状前指标， 以便及早干预和规划。 在一个非常成功的第一阶段项目之后，CTX已经能够快速开发移动的测试 可以同步捕获原始传感器流并将其传输到云服务器 以便随后进行分析和报告。已经开发了复杂的分析管道， 将这些传感器流转换成认知表型（例如，提取眼球运动数据 在认知测试期间拍摄的自拍视频）。使用CTX框架，Parabon团队 已经开发了一款Apple® iOS®移动的应用程序，该应用程序具有用于评估口头语言的原理验证测试 回忆、眼球运动、运动功能和情景记忆。 在第二阶段，我们建议开发两套新的CTX测试，用于一次性认知障碍 筛查和认知表现监测，以及表型提取管道， 每个.我们将在正常和受影响的队列中评估测试，以确定可用性、用户保留率 以及所得到的表型是否能够使临床医生进行准确的认知评估。我们 具体目标是（1）开发新的、引人入胜的认知测试和管道来评估视觉 搜索和目标，表达和接受语言，运动和情景记忆; (2)在认知正常和受损的队列中进行测量;和（3）分析和准备 用于向FDA发表和提交上市前申请的数据。

PROJECT SUMMARY In this Phase II SBIR project, Parabon NanoLabs will complete the development, validation and commercialization of CTX, a revolutionary smartphone- and tablet-based cognitive testing platform for collection and analysis of measurements of cognitive performance (“phenotypes”). Traditionally, cognitive assessments are performed in a clinic using either simple surveys that assess only some aspects of cognition or expensive, single-purpose equipment such as eye tracking stations. Such testing lacks the frequency and precision needed to detect subtle early changes that signal the onset of mild cognitive impairment (MCI) or early-symptomatic dementia. Instead, CTX will take full advantage of mobile sensors (e.g., audio, video, touchscreen, and motion) to enable in-depth cognitive testing anytime, anywhere. Regular use of CTX will allow a clearer picture of each user's cognitive abilities to emerge, enabling early detection of subtle changes. CTX is not intended to replace neurologists but instead to extend their reach by allowing regular, widespread screening for improved disease detection and patient monitoring. The long-range goal of CTX is to allow aging adults to monitor and manage their cognitive health more effectively and to provide pre-symptomatic indicators of pending dementia to patients and their clinicians, thus enabling early intervention and planning. After a highly successful Phase I project, CTX already enables rapid development of mobile tests that can capture raw sensor streams in a synchronized fashion and transmit them to a cloud server for subsequent analysis and reporting. Sophisticated analytics pipelines have been developed to convert these sensor streams into cognitive phenotypes (e.g., extracting eye movement data from selfie video taken during a cognitive test). Using the CTX framework, the Parabon team has already developed an Apple® iOS® mobile app with proof-of-principle tests for assessing verbal recall, eye movement, motor function, and episodic memory. In Phase II, we propose to develop two new suites of CTX tests for one-time cognitive impairment screening and cognitive performance monitoring, as well as phenotype extraction pipelines for each. We will evaluate tests in normal and affected cohorts to determine usability, user retention and whether resulting phenotypes enable accurate cognitive assessments by clinicians. Our specific aims are to (1) Develop new and engaging cognitive tests and pipelines for assessing visual search and targeting, expressive and receptive language, motor movement and episodic memory; (2) Validate measures in cognitively normal and impaired cohorts; and (3) Analyze and prepare data for publication and premarket submissions to the FDA.