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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AG080861-01
Agency Tracking Number: R44AG080861
Amount: $2,496,364.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PAS19-316
Timeline
Solicitation Year: 2019
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-30
Award End Date (Contract End Date): 2024-08-31
Small Business Information
57 Chapel St, Suite 200
Newton, MA 02458-1080
United States
DUNS: 802270988
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ASHKAN VAZIRI
 (888) 589-6213
 ashkan.vaziri@biosensics.com
Business Contact
 NEDA MOVAGHAR
Phone: (888) 589-6213
Email: neda.movaghar@biosensics.com
Research Institution
N/A
Abstract

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.

* Information listed above is at the time of submission. *

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