Phase I Amount
$1,250,000
Frontotemporal lobar degeneration (FTLD) syndromes span the spectrum of neurodegenerative disordersaffecting 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 cognitivefunction in FTLD syndromes using wearable sensors and digitized tests. We will validate this solution inProgressive Supranuclear Palsy (PSP) by collecting longitudinal data from 60 PSP patients over a period of 12months. PSP is a severe and rapidly progressive FTLD syndrome that lacks effective treatment and leads torapid onset of dementia, disability and death. The rapid progression of PSP will allow us to validate the solutionwithin 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 wearablesensor 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 collectedusing BioDigit Home, a unified solution for the collection of digital biomarkers that is currently being used inseveral NIH-funded studies and pharma-sponsored clinical trials in neurological disorders. BioSensics hasalready customized its BioDigit Home solution to monitor motor, speech and cognitive functions in PSP, and hascarried 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, speechand cognitive function that will enable objective assessment of PSP disease severity and progression, therebycreating a multi-modal remote monitoring solution for PSP. These tools will accelerate clinical trials that arefocused on the development of novel therapeutics for tauopathies (i.e., FTD, PSP CBS) and can be readilyadapted 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 appliedgovernmental research funding into real commercial results. The initial market for our technology ispharmaceutical clinical trials, where BioSensics is a vendor of record of medical-grade wearable sensors anddigital clinical trial technologies for multiple pharmaceutical companies. The current project will significantlybroaden BioSensics' offerings to pharmaceutical companies, specifically by providing a solution for digitalassessments of speech, motor and cognition function, which are relevant to many diseases. This commercialpotential is fully aligned with the latest recommendations from the FDA, NSF and NIH to digitize clinical trials.
Public Health Relevance Statement: Project Narrative The objective of this project is to develop a robust multi-modal platform for remote monitoring of speech, psychomotor and cognitive function in Frontotemporal lobar degeneration (FTLD) syndromes - focusing initially on Progressive supranuclear palsy (PSP, a rapidly progressing FTLD syndrome), and later extending to Corticobasal syndrome and Frontotemporal dementia. In this Direct Phase II project, we will use wearable sensors and computerized speech, psychomotor, and cognitive assessments to create outcome measures and digital biomarkers for FTLD syndromes and will use the solution to monitor 60 PSP patients for 12 months. The developed tools will facilitate clinical trials that are focused on novel therapeutics for tau-related diseases and can be readily adapted to other neurodegenerative diseases.
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