Presented at the annual meetings of:
The International Society for CNS Clinical Trials, Washington, DC
New Clinical Drug Evaluation Unit (National Institute of Mental Health), Boca Raton, FL.
BACKGROUND
- Representatives from FDA have repeatedly stated that improvement on traditional measures of cognition will not be sufficient for approval of a new drug for cognitive enhancement.
- In addition to showing improvement on traditional cognitive measures, patients must also demonstrate improvement on a measure of “functional capacity” meant to approximate competence in activities of daily living.
- Currently, no co-primary measure has been universally endorsed and the method to achieve this end lacks definition.
- The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is designed to create a realistic, simulated environment using state-of-the-art gaming software to assess patients’ proficiency for navigating everyday life.