Integrated Neurocognitive and Sleep Behavior Profiler for the Endophenotypic Classification of Dementia Subtypes INSPECDS

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AG050326-01A1
Agency Tracking Number: R44AG050326
Amount: $1,438,409.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PAR14-088
Timeline
Solicitation Year: 2014
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-30
Award End Date (Contract End Date): 2019-05-31
Small Business Information
2237 FARADAY AVE STE 100, Carlsbad, CA, 92008-7240
DUNS: 969842715
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 CHRIS BERKA
 (760) 720-0099
 chris@b-alert.com
Business Contact
 CHRIS BERKA
Phone: (760) 720-0099
Email: chris@b-alert.com
Research Institution
N/A
Abstract
DESCRIPTION provided by applicant It is estimated that neurodegenerative diseases causing dementia will surpass cancer as the leading cause of death by the year Alzheimerandapos s disease AD is the leading cause of dementia followed by synucleinopathies such as dementia with Lewy bodies DLB and Parkinsonandapos s disease with dementia PDD Among clinical researchers focused on investigating the varying etiologies genetic associations biomarkers and treatment options for these neurodengenerative diseases there is an urgent need for effective tools to aid in the classification of dementia subtypes in the earliest detectable stages of the pathophysiological process To address this unmet need Advanced Brain Monitoring ABM proposes to leverage two previously developed technologies to create an Integrated Neurocognitive and Sleep Behavior Profiler for the Endophenotypic Classification of Dementia Subtypes INSPECDS The core components of the INSPECDS platform will be a previously developed Alertness and Memory Profiler AMP a recently developed Sleep Profiler and integrated machine learning classification algorithms hosted on a secure cloud based infrastructure for automated data processing analysis and reporting The AMP was developed and validated during a previous NIH funded SBIR Phase I II project for the purpose of detecting the neurocognitive effects of sleep deprivation in adults diagnosed with obstructive sleep apnea The AMP is truly unique among neurocognitive testing platforms in that it is the only one which integrates advanced electrophysiological measures e g channel wireless EEG and ECG during the performance of computerized neurocognitive tasks This advanced capability permits researchers to explore real time relations between fluctuations in alertness discrete cognitive functions and specific neural processes believed to subserve observed performance deficits The Sleep Profiler is an FDA cleared easily applied wireless EEG device that was developed and validated to measure sleep architecture for in home sleep studies With integrated measures of submental chin EMG and wireless accelerometers to monitor head and limb movements the Sleep Profiler is an ideal device for quantifying the characteristics of REM sleep behavior disorder RBD which is considered to be a prodromal expression of synucleinopathy Furthermore the application of sophisticated machine learning classification algorithms will streamline the processing and analyses of these data to derive statistical probabilities of various dementia subtypes The overarching goal of the current Direct to Phase II SBIR project is to develop a secure cloud based infrastructure to compile the data obtained from the AMP and Sleep Profiler train classification algorithms to discriminate among dementia subtypes validate diagnostic accuracy and integrate optimized classifiers within the cloud based architecture Once completed the INSPECDS system will be the first clinical research tool of its kind and find immediate application in both university based research settings and pharmaceutical industry clinical trials to aid in the endophenotypic stratification of research participants PUBLIC HEALTH RELEVANCE Among clinical researchers focused on investigating the varying etiologies genetic associations clinical course and treatment options for neurodengenerative diseases there is an urgent need for effective tools to aid in the classification of dementia subtypes in the earliest detectable stages of the pathophysiological process To address this unmet need Advanced Brain Monitoring Carlsbad CA is developing Integrated Neurocognitive and Sleep Behavior Profilers for the Endophenotypic Classification of Dementia Subtypes INSPECDS which will provide an inexpensive non invasive solution combining neurocognitive electrophysiological EEG ECG EMG and sleep behavior assessment into a single integrated system featuring automated scoring and classification algorithms Once completed the INSPECDS system will be the first clinical research tool of its kind and find immediate application in university based research settings and pharmaceutical industry clinical trials to aid in the endophenotypic stratification of research participants

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

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