VeraSci Innovation Lab
The VeraSci Innovation Lab pressure-tests the validity of new technologies designed to accelerate clinical development and facilitate the approval and use of novel therapies. Our scientists pair their scientific expertise with the latest technological advances to determine if new innovations will be useful for clinical trials. Additionally, we collaborate with sponsor companies to develop custom, fit-for-purpose assessments.
The Innovation Lab scientists collaborate with software vendors, device vendors, and regulators to develop and assess novel endpoints for clinical trials. Work in the Innovation Lab led to the Virtual Reality Functional Capacity Assessment Tool’s (VRFCAT) acceptance in the FDA’s Clinical Outcome Assessment (COA) Qualification program.
Testing Industry Grade Wearable Devices for Real-Time Functional Assessments
The Innovation Lab is conducting a validation study that evaluates the use, sensitivity, and reliability of industry-grade wearable devices for the real-time capture of gait and actigraphy measures for continuous passive data collection in clinical trials for Alzheimer’s disease and related disorders.
Advances in understanding Alzheimer’s disease progression have ignited widespread interest in the development of disease-modifying therapeutics intended for use in preclinical, mostly asymptomatic, populations. As a result, industry sponsors need cognitive instruments with increased sensitivity to early cognitive decline with appropriate normative data. The Innovation Lab conducted a study utilizing the Brief Assessment of Cognition (BAC) in individuals with subjective cognitive decline. The study demonstrated that the BAC strongly differentiates older people who are concerned about their cognition versus similarly aged people who are not. The BAC also has good reliability over time.
The Innovation Lab has also conducted a study to assess the potential of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) as a performance-based assessment of instrumental activities of daily living (iADLs). The study determined that the VRFCAT is sensitive to differences between older adults with and without subjective cognitive decline and differences between patients with mild cognitive impairment (MCI) and mild AD. These study results suggest that the VRFCAT is sensitive to iADL functioning among patients at different stages in the Alzheimer’s disease continuum.