The recent shift in Alzheimer?s disease (AD) clinical 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 time. In this context, physical frailty together with cognitive impairment (known as ?cognitive frailty?) is shown to be a strong and independent predictor of cognitive decline over time. The International Association of Gerontology and Geriatrics, as 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/AD, and loss of independence. We 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 software. The assessment performed using this platform is the Instrumented Trail Making Task or iTMT . This 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 environment. The assessment is based on measuring the execution time and user performance during multiple tasks that involve visual search, scanning, speed of processing, mental flexibility, and executive function. In performing each task, motor performance is quantified by measuring ankle velocity and cognitive performance is quantified by assessing motor-planning error, working memory, and time needed to complete the task. In our pilot study, which was recently published in Gerontology, we demonstrated that iTMT can be used to assess cognitive-motor performance and identify aMCI and AD in older adults. Furthermore, we have demonstrated the ability of iTMT to determine frailty status. The iTMT could be used as an alternative test to the dual-task walking test to assess and quantify cognitive frailty in older adults. The unique benefits of the proposed platform include objectivity, low cost, time-savings, multifaceted assessment, and being easy to use. This STTR Phase I study aims to transfer this innovative and patented technology from Baylor College of Medicine to BioSensics LLC for further development, clinical testing, and commercialization. BioSensics is a privately-held biomedical firm specialized in wearable technologies for healthcare, with a proven record of rapidly transitioning governmental research funding into commercialized medical devices and technologies. The iTMT product proposed here will be added to the current line of point-of-care assessment tools commercialized by BioSensics, which includes devices for gait and fall risk (LEGSys), balance (BalanSens) and Frailty (Frailty Meter).
Recently proposed National Institute of Aging (NIA) and Alzheimer's Association (AA) guidelines for the diagnosis of Alzheimer?s disease (AD) recognize the need to identify mild cognitive impairment (MCI) and its progression toward AD. While cognitive impairment can be identified using pencil and paper-based screening tools, these assessment tools are semi-objective, and time consuming, and are often insensitive to determine physical frailty, which is known to be a predictor of further cognitive decline overtime and acceleration toward dementia or AD. This grant application proposes designing and commercializing a low-cost, objective, time- efficient, and easy-to-apply instrumented trail-making test system (iTMT) to identify and track cognitive frailty, regardless of setting, patient education level, and examiner experience.