A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration Syndromes

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Project Summary/Abstract Frontotemporal lobar degeneration (FTLD) syndromes span the spectrum of neurodegenerative disorders affecting movement and cognitive function and are pathologically related to Alzheimer's disease. In this project, we will develop a robust multi-modal platform for remote monitoring of motor symptoms, speech and cognitive function in FTLD syndromes using wearable sensors and digitized tests. We will validate this solution in Progressive Supranuclear Palsy (PSP) by collecting longitudinal data from 60 PSP patients over a period of 12 months. PSP is a severe and rapidly progressive FTLD syndrome that lacks effective treatment and leads to rapid onset of dementia, disability and death. The rapid progression of PSP will allow us to validate the solution within the timeline of this Direct Phase II SBIR project and facilitate future studies in FTLD syndromes. In this Direct Phase II project, we will recruit 60 participants with PSP from 2 leading CurePSP Centers of Care. These participants will be monitored for 12 months. The sensor data will be collected using PAMSys, a wearable sensor developed by the support from a NIH STTR grant award. PAMSys is patented (U.S. Patents # 8,206,325, 9,005,141, and 9,901,209), validated and commercialized by BioSensics. The digitized tests will be collected using BioDigit Home, a unified solution for the collection of digital biomarkers that is currently being used in several NIH-funded studies and pharma-sponsored clinical trials in neurological disorders. BioSensics has already customized its BioDigit Home solution to monitor motor, speech and cognitive functions in PSP, and has carried out a pilot study with 7 PSP patients, who were monitored for up to 3 months using the developed system. We will collect data from 60 PSP patients in this aim to develop a set of algorithms for monitoring motor, speech and cognitive function that will enable objective assessment of PSP disease severity and progression, thereby creating a multi-modal remote monitoring solution for PSP. These tools will accelerate clinical trials that are focused on the development of novel therapeutics for tauopathies (i.e., FTD, PSP CBS) and can be readily adapted to many neurodegenerative diseases, including Parkinson's disease, multiple system atrophy, amyotrophic lateral sclerosis, myotonic dystrophy and stroke. BioSensics is a 2020 Tibbetts Award winner with a proven track record of rapidly transitioning applied governmental research funding into real commercial results. The initial market for our technology is pharmaceutical clinical trials, where BioSensics is a vendor of record of medical-grade wearable sensors and digital clinical trial technologies for multiple pharmaceutical companies. The current project will significantly broaden BioSensics' offerings to pharmaceutical companies, specifically by providing a solution for digital assessments of speech, motor and cognition function, which are relevant to many diseases. This commercial potential is fully aligned with the latest recommendations from the FDA, NSF and NIH to digitize clinical trials.