Smartphone phenotype collection for diagnostic screening of mild cognitive impairment

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.