Cognitive deficits in schizophrenia are profound and devastating, with schizophrenia patients performing an average of 1.5 standard deviations below the healthy population on measures of cognitive function. In fact, deficits in cognition more significantly erode a patient?s quality of life than any other aspect of the disorder, including psychosis. FDA has guided drug developers focused on cognitive improvement to demonstrate not only basic improvement on cognitive endpoints, but also improvement on a measure of functional capacity. While achieving this so-called ?co-primary? functional endpoint provides a clinically meaningful benefit to the patient, the field currently offers limited options for reliable quantification of functional capacity. To address this gap, NeuroCog Trials has developed the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a computerized test of a patient?s ability to navigate everyday situations, for use as a co-primary endpoint in schizophrenia cognition clinical trials. During our Phase II SBIR program, the VRFCAT was validated in a multi-center study of 160 patients and 160 healthy controls. The VRFCAT demonstrated excellent test-retest reliability, strong discrimination between schizophrenia patients and healthy controls, and reduced practice effects in comparison to the current standard measure of functional capacity, the UCSD Performance- based Skills Assessment (UPSA). At the recommendation of UPSA developer and co-investigator for the Phase II project, Tom Patterson, we used the Validation of Intermediate Measures (VIM) version of the UPSA, or UPSA-VIM (referred to here simply as the UPSA). The VRFCAT also exhibited strong correlations with the MATRICS Consensus Cognitive Battery (MCCB) - the FDA gold standard assessment for cognition - indicating that pairing the tests is likely to provide reliable assessment of both cognitive performance and functional capacity in future clinical trials. During Phase IIB, NeuroCog Trials will leverage international relationships forged by our Principal Investigator (Dr. Alexandra Atkins) and Founder (Dr. Richard Keefe) to collect normative data to support use of the US/English version of VRFCAT in clinical drug trials and to develop multicultural versions of the VRFCAT. Given that drug trials intended to support US marketing approval are using increasingly large numbers of international sites, making the VRFCAT available for the languages and cultures in these countries is essential. Collaborators with expertise in each language, including Russian, Polish, German, Italian and Spanish spoken in the US, have been identified and, along with our drug development partners, agree this is an urgently unmet need. NeuroCog has comprehensive experience validating tests translated for new languages and cultures, and will perform studies for each culture-specific VRFCAT version during Phase IIB. Coupled with collection of much-needed normative data, this initiative will accelerate the development of therapeutics intended for US approval by enabling VRFCAT testing in countries preferred by our drug development partners for their Phase II and Phase III trials.
Cognitive impairment associated with schizophrenia (CIAS) has emerged as an important target for psychopharmacological treatment. FDA has guided drug developers focused on cognitive improvement to demonstrate not only basic improvement on cognitive endpoints, but also improvement on a measure of functional capacity. However, there are limited options for reliable quantification of functional capacity. NeuroCog Trials has developed and validated the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a computerized test that characterizes a patient?s ability to navigate everyday situations, for use as a co-primary endpoint in schizophrenia clinical trials. The current project aims to refine the tool, develop population-based norms, and translate and culturally adapt the VRFCAT for international use.
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|Ruse, Stacy A; Davis, Vicki G; Atkins, Alexandra S et al. (2014) Development of a virtual reality assessment of everyday living skills. J Vis Exp :|