NIH Grant Will Support the Collection of US Census-Matched Norms and Internationalization of the Virtual Reality Functional Capacity Assessment Tool, VRFCAT™.
DURHAM, NORTH CAROLINA, August 11, 2016 – NeuroCog Trials, Inc., the leading cognitive services provider for the clinical trials industry, today announced that it has been awarded a Phase IIB grant from the Small Business Innovation Research (SBIR) program of the National Institute of Mental Health (NIMH) to collect additional normative data and internationalize the Virtual Reality Functional Capacity Assessment Tool or VRFCAT™.
The 3-year project builds on the successful Phase I and II grants that funded the development of the VRFCAT and validation in patients with schizophrenia and healthy controls. The VRFCAT is a computerized measure that was developed to be a reliable, valid, and sensitive measure of functional capacity. The VRFCAT presents participants with a realistic, immersive environment to recreate routine activities of daily living such as planning a meal, using transportation, and shopping. The VRFCAT offers different scenarios to eliminate practice effects. The project, led by Co-Principal Investigators Alexandra S. Atkins, Ph.D. and Richard Keefe, Ph.D., will enable NeuroCog Trials to generate a large normative sample of cognitively healthy individuals matched to the US population on key demographic factors. The grant will also fund the development, localization and validation of US Spanish, Italian, German, Russian, and Polish language versions of the assessment to support its use in multinational clinical trials.
Richard Keefe, Ph.D., Founder and Chief Executive Officer of NeuroCog Trials, said
“We are excited by the continued NIMH support of the VRFCAT for use in clinical trials that have the potential to benefit the lives of those suffering from schizophrenia, affective disorders and other devastating psychiatric disorders and neurodegenerative illnesses, including early Alzheimer’s disease. The FDA has stated that in order to receive approval for new drugs in these areas, patients must show meaningful gains in functional capacity, or the degree to which they have changed their potential to alter real-world behavior. We believe the VRFCAT is the next generation assessment capable of measuring this change.”
About NeuroCog Trials
NeuroCog Trials Inc. is the leading cognition services company for the pharmaceutical industry. For more than 10 years, NeuroCog Trials has provided consulting, site screening, rater training and certification, and data review services to more than 100 clinical trials in over 25 countries.
This research is supported by the National Institute of Mental Health of the National Institutes of Health under Award Number R44MH084240. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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