Characterizing Alzheimer's Disease with INSPECDS: Integrated Neurocognitive and Sleep-Behavior Profiler for the Endophenotypic Classification of Dementia Subtypes

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R44AG054256-01A1
Agency Tracking Number: R44AG054256
Amount: $1,086,647.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PAR14-088
Timeline
Solicitation Year: 2014
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-07-15
Award End Date (Contract End Date): 2020-04-30
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
PROJECT SUMMARY AND ABSTRACTIt is estimated that Alzheimer s and other neurodegenerative diseases causing dementia will surpass cancer as the leading cause of death by the yearAlzheimer s is the leading cause of dementiafollowed by synucleinopathiesincluding dementia with Lewy bodiesDLBand Parkinson s disease with dementiaPDDFronto temporal dementia and Vascular dementiaAmong clinical researchers focused on investigating the varying etiologiesgenetic associationsbiomarkersand treatment options for Alzheimer s diseasethere is an urgent need for effective tools to aid in the classification of dementia subtypesin the earliest detectable stages of the pathophysiological processTo address this unmet need Advanced Brain MonitoringABMproposes to leverage day and night assessment technologies to create an Integrated Neurocognitive and Sleep Behavior Profiler for the Endophenotypic Classification of Dementia SubtypesINSPECDSto profile Alzheimer s and other dementiasThe core components of the INSPECDS platform will be the Alertness and Memory ProfilerAMPthe Sleep Profilerand integrated machine learningclassification algorithmshosted on a securecloud basedinfrastructure for automated data processinganalysisand reportingThe AMP was developed and validated intially for the purpose of detecting the neurocognitive effects of sleep deprivation in adults diagnosed with obstructive sleep apnea but has more recently been applied to assess Alzheimer s and Parkinson s diseaseThe AMP is unique among neurocognitive testing platforms in that it is the only one which integrates advancedelectrophysiological measurese gchannelwireless EEG and ECGduring the performance of computerized neurocognitive tasks and has proven effective in characterizing cognitive decline in Alzheimer sThis advanced capability permits researchers to explore realtime relations between fluctuations in alertnessdiscrete cognitive functionsand specific neural processes believed to subserve observed performance deficits in Alzheimer s and other dementiasThe Sleep Profiler is an FDA clearedeasily appliedwireless EEG device that was developed and validated to measure sleep architecture for in home sleep studies with submentalchinEMG and wireless accelerometers to monitor head and limb movements to quantify the characteristics of REM sleep behavior disorderRBDconsidered to be a prodromal expression of synucleinopathyFurthermorethe application of sophisticatedmachinelearningclassification algorithms will streamline the processing and analyses of these data to derive statistical probabilities of Alzheimer s and other dementia subtypesThe overarching goal of the currentDirect to Phase IISBIR project is to finalize implementation of a securecloud based infrastructure to compile the data obtained from the AMP and Sleep Profilertrain classification algorithms to discriminate among Alzheimer s and other dementia subtypesvalidate diagnostic accuracyand integrate optimized classifiers within the cloudbased architectureOnce completedthe 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 Alzheimer s and other dementias

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

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