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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: National Institutes of Health
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
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
Carlsbad, CA 92008-7240
United States
DUNS: 969842715
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (760) 720-0099
Business Contact
Phone: (760) 720-0099
Research Institution

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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