Testing Industry-Grade Wearable Devices for Real-Time Functional Assessment.

VeraSci’s Innovation Lab led by Dr. Alexandra Atkins has begun evaluating the ease of use, sensitivity, and reliability of two industry-grade wearable devices for the real-time capture of gait and actigraphy measures. VeraSci, a global clinical technology, research, and development services company, is making significant strides toward the inclusion of validated wearable technologies for continuous passive data collection in clinical trials for those at risk for Alzheimer’s Disease (AD) and related disorders.

If appropriately implemented, measurements from certified wearable technologies have the potential to revolutionize the future of AD prevention trials by facilitating the development of siteless clinical trial designs. The project will also assess the relationship between wearable device endpoints and standard performance-based measures of cognition and function. The study enrolled the first of 100 older adults with and without subjective cognitive decline in late October.

Devices under investigation include a wireless insole worn in standard footwear that allows for continuous assessment of gait, walking and balance, and a wrist-worn device that offers continuous measurement of heart rate, motor activity, skin temperature, Galvanic Skin Response, and sleep. The devices were selected based on their potential to produce reliable endpoints that may ultimately pass the high bar set for use in regulated clinical trials. Primary considerations included measurement accuracy, data security, and potential for compliance with HIPAA and FDA-Part 11 regulations.

Dr. Luca Pani, VeraSci VP for Regulatory Strategy and Market Access Innovation, and former Director General of the Italian Medicines Agency commented, “The potential for greater integration of wearables in CNS trials to collect high quality real world evidence (RWE) before, during and after product approval is enormous. To be truly informative, however, endpoints collected by these devices must undergo the same clinical and technological validation process required by other currently accepted tools.”

Through their Innovation Lab, VeraSci continually seeks to improve the tools and methods of measurement in clinical trials in multiple therapeutic areas. Prior work includes the collection of robust normative data for 650 cognitively healthy individuals on the tablet-based Brief Assessment of Cognition (BAC) and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a performance-based functional assessment that was recently accepted into the FDA qualification program for cognitive impairment in schizophrenia.