Smart driving technology for non-invasive detection of age-related cognitive decline

ABSTRACT Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) significantly reduce the quality of life for patients, place a tremendous burden on caregivers, and are among the leading causes of death in adults over 65. Delaying or reversing the onset of mild cognitive impairment (MCI)—an early stage of dementia—could profoundly impact nearly 7 million older adults, their families, and reduce the strain on the public health system. Therefore, creating a system to diagnose MCI or the pre-symptomatic stages of AD/ADRD is of paramount importance for improving early intervention and treatment strategies. Several studies have established a link between MCI and driving behavior, suggesting that driving could serve as an effective means of assessing cognitive function under free-living conditions. However, no commercial products currently offer this capability. We hypothesize that an unobstructive, continuous, cost- effective system capable of assessing the driver’s biometrics, driving signatures and driver’s environment could detect early signs of neurodegenerative diseases, providing a critical “window of opportunity” to delay the onset of dementia. In this work, we aim to develop and validate the Smart Driving System, an unobtrusive and car- make agnostic sensing system for the daily assessment of cognitive health under free-living conditions. The system: 1) automatically records and analyzes data with the integrated multi-modal biosensor array and a companion App in the car’s infotainment; 2) detects novel driver biomarkers, such as metabolic rate changes linked to driving performance, which correlate with cognitive function; and 3) leverages an Artificial Intelligence (AI) algorithm to predict cognitive performance and identify early signs of MCI. The TF Health Corp., in collaboration with Arizona State University and Barrow Neurological Institute, will work together to build the unobtrusive, vehicle-based sensing system for the daily assessment of driver’s biometrics and performance, and age-related cognitive decline. The ultimate goal is to create a new technology for early diagnosis of dementia under free-living conditions, improving patient care options and promoting preventive interventions for cognitive decline. This Phase II proposal builds upon the success of Phase I, where 100% of the milestones were achieved. In Phase II, the proof-of-concept prototype from Phase I (Smart Pad System) will be further developed into a commercialization-ready product, the Smart Driving System, with clinical validation conducted through a pilot study. Looking ahead, Phase IIB will focus on cross- sectional and longitudinal population studies to assess the system's effectiveness across a broader demographic and cognitive trajectories, respectively.