SBIR/STTR Award attributes
ABSTRACT The recent shift in Alzheimer s diseaseADclinical research from clinical diagnosis toward the goal of developing neuroprotective therapies has highlighted the need for a robust and rapidly administered cognitive assessment tool capable of identifying individuals in the earliest stages of cognitive decline and measuring subtle changes in cognitive motor performance over timeIn this contextphysical frailty together with cognitive impairmentknown ascognitive frailtyis shown to be a strong and independent predictor of cognitive decline over timeThe International Association of Gerontology and Geriatricsas well as The International Academy on Nutrition and Aging have recommended the use of cognitive frailty measurement for determining pathways of MCI progression toward dementia ADand loss of independenceWe have recently developed a novel cognitive frailty measurement tool that is based on a combination of a wearable sensor attached to patient s shin and virtual reality softwareThe assessment performed using this platform is the Instrumented Trail Making Task or iTMTThis innovative tool for objective and simultaneous assessment of both motor and cognitive performance is used to examine the ability of the patient to execute a trail making task in a virtual environmentThe assessment is based on measuring the execution time and user performance during multiple tasks that involve visual searchscanningspeed of processingmental flexibilityand executive functionIn performing each taskmotor performance is quantified by measuring ankle velocity and cognitive performance is quantified by assessing motor planning errorworking memoryand time needed to complete the taskIn our pilot studywhich was recently published in Gerontologywe demonstrated that iTMT can be used to assess cognitive motor performance and identify aMCI and AD in older adultsFurthermorewe have demonstrated the ability of iTMT to determine frailty statusThe iTMT could be used as an alternative test to the dual task walking test to assess and quantify cognitive frailty in older adultsThe unique benefits of the proposed platform include objectivitylow costtime savingsmultifaceted assessmentand being easy to useThis STTR Phase I study aims to transfer this innovative and patented technology from Baylor College of Medicine to BioSensics LLC for further developmentclinical testingand commercializationBioSensics is a privately held biomedical firm specialized in wearable technologies for healthcarewith a proven record of rapidly transitioning governmental research funding into commercialized medical devices and technologiesThe iTMT product proposed here will be added to the current line of point of care assessment tools commercialized by BioSensicswhich includes devices for gait and fall riskLEGSysbalanceBalanSensand FrailtyFrailty MeterProject Narrative Recently proposed National Institute of AgingNIAand Alzheimerandapos s AssociationAAguidelines for the diagnosis of Alzheimer s diseaseADrecognize the need to identify mild cognitive impairmentMCIand its progression toward ADWhile cognitive impairment can be identified using pencil and paper based screening toolsthese assessment tools are semi objectiveand time consumingand are often insensitive to determine physical frailtywhich is known to be a predictor of further cognitive decline overtime and acceleration toward dementia or ADThis grant application proposes designing and commercializing a low costobjectivetimeefficientand easy to apply instrumented trail making test systemiTMTto identify and track cognitive frailtyregardless of settingpatient education leveland examiner experience
