Smartphone phenotype collection for diagnostic screening of mild cognitive impairment

项目总结 在这个第二阶段的SBIR项目中，Parabon NanoLabs将完成开发、验证和 基于智能手机和平板电脑的革命性认知测试CTX的商业化 收集和分析认知表现测量(“表型”)的平台。 传统上，认知评估是在临床上使用以下两种简单调查之一进行的 只评估认知的某些方面或昂贵的单一用途设备，如眼球跟踪 站台。这种测试缺乏检测早期细微变化所需的频率和精度， 发出轻度认知障碍(MCI)或早期症状性痴呆的信号。相反， CTX将充分利用移动传感器(例如音频、视频、触摸屏和运动)来 随时随地实现深度认知测试。定期使用CTX将使患者获得更清晰的 每个用户的认知能力图都会显现出来，从而能够及早发现细微变化。CTX 并不是为了取代神经科医生，而是为了通过允许常规的、 广泛进行筛查，以改进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，并 向患者及其临床医生提供潜在痴呆症的症状前指标，从而 能够及早进行干预和规划。 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测试 可以以同步方式捕获原始传感器流并将其传输到云服务器 以供后续分析和报告。先进的分析管道已被开发为 将这些传感器流转换为认知表型(例如，从 在认知测试中拍摄的自拍视频)。使用CTX框架，Parabon团队已经 已经开发了一款Apple®iOS®移动应用程序，带有用于评估语言能力的原则证明测试 回忆、眼球运动、运动功能和情景记忆。 在第二阶段，我们建议开发两套针对一次性认知障碍的CTX测试套件 筛查和认知表现监测，以及表型提取管道 每个人。我们将评估正常和受影响队列中的测试，以确定可用性、用户保留率 以及由此产生的表型是否使临床医生能够进行准确的认知评估。我们的 具体目标是(1)开发新的、引人入胜的认知测试和评估视力的管道 搜索和定向、表达能力和接受性语言、运动动作和情节记忆； (2)验证认知正常和受损队列中的测量方法；以及(3)分析和准备 向FDA公布的数据和上市前提交的数据。

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.