The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

Project SummaryCognitive deficits in schizophrenia are profound and devastatingwith schizophrenia patients performing an average ofstandard deviations below the healthy population on measures of cognitive functionIn factdeficits in cognition more significantly erode a patient s quality of life than any other aspect of the disorderincluding psychosisFDA has guided drug developers focused on cognitive improvement to demonstrate not only basic improvement on cognitive endpointsbut also improvement on a measure of functional capacityWhile achieving this so calledco primaryfunctional endpoint provides a clinically meaningful benefit to the patientthe field currently offers limited options for reliable quantification of functional capacityTo address this gapNeuroCog Trials has developed the Virtual Reality Functional Capacity Assessment ToolVRFCATa computerized test of a patient s ability to navigate everyday situationsfor use as a co primary endpoint in schizophrenia cognition clinical trialsDuring our Phase II SBIR programthe VRFCAT was validated in a multi center study ofpatients andhealthy controlsThe VRFCAT demonstrated excellent test retest reliabilitystrong discrimination between schizophrenia patients and healthy controlsand reduced practice effects in comparison to the current standard measure of functional capacitythe UCSD Performancebased Skills AssessmentUPSAAt the recommendation of UPSA developer and co investigator for the Phase II projectTom Pattersonwe used the Validation of Intermediate MeasuresVIMversion of the UPSAor UPSA VIMreferred to here simply as the UPSAThe VRFCAT also exhibited strong correlations with the MATRICS Consensus Cognitive BatteryMCCBthe FDA gold standard assessment for cognitionindicating that pairing the tests is likely to provide reliable assessment of both cognitive performance and functional capacity in future clinical trialsDuring Phase IIBNeuroCog Trials will leverage international relationships forged by our Principal InvestigatorDrAlexandra Atkinsand FounderDrRichard Keefeto collect normative data to support use of the US English version of VRFCAT in clinical drug trials and to develop multicultural versions of the VRFCATGiven that drug trials intended to support US marketing approval are using increasingly large numbers of international sitesmaking the VRFCAT available for the languages and cultures in these countries is essentialCollaborators with expertise in each languageincluding RussianPolishGermanItalian and Spanish spoken in the UShave been identified andalong with our drug development partnersagree this is an urgently unmet needNeuroCog has comprehensive experience validating tests translated for new languages and culturesand will perform studies for each culture specific VRFCAT version during Phase IIBCoupled with collection of much needed normative datathis 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 Project NarrativeCognitive impairment associated with schizophreniaCIAShas emerged as an important target for psychopharmacological treatmentFDA has guided drug developers focused on cognitive improvement to demonstrate not only basic improvement on cognitive endpointsbut also improvement on a measure of functional capacityHoweverthere are limited options for reliable quantification of functional capacityNeuroCog Trials has developed and validated the Virtual Reality Functional Capacity Assessment ToolVRFCATa computerized test that characterizes a patient s ability to navigate everyday situationsfor use as a co primary endpoint in schizophrenia clinical trialsThe current project aims to refine the tooldevelop population based normsand translate and culturally adapt the VRFCAT for international use