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The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

Award Number: R44MH084240
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2009
PERIOD OF PERFORMANCE END DATE: 07/31/2021

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The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) - DESCRIPTION (provided by applicant): 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, includig 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 reliabe 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2018	VERASCI, LLC	3211 SHANNON RD	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	000	6	2/2/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = -$19,815 )
2022	2018	VERASCI, LLC	3211 SHANNON RD	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	000	6	7/11/2022	SUPPLEMENT FOR EXPANSION	-$19,815
														Subtotal = -$19,815

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	NCT HOLDINGS, INC.	3211 SHANNON RD STE 300	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	000	6	9/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $869,832 )
2018	2018	NCT HOLDINGS, INC.	3211 SHANNON RD STE 300	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	001	6	9/13/2018	SUPPLEMENT FOR EXPANSION	$248,308
2018	2018	NCT HOLDINGS, INC.	3211 SHANNON RD STE 300	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	000	6	8/1/2018	NON-COMPETING CONTINUATION	$621,524
														Subtotal = $869,832

Issue Date FY: 2017 ( Subtotal = $710,216 )
2017	2017	NCT HOLDINGS, INC.	3211 SHANNON RD STE 300	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	000	5	7/15/2017	NON-COMPETING CONTINUATION	$710,216
														Subtotal = $710,216

Issue Date FY: 2016 ( Subtotal = $685,656 )
2016	2016	NEUROCOG TRIALS INC	3211 SHANNON ROAD	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	000	4	7/28/2016	COMPETING CONTINUATION	$685,656
														Subtotal = $685,656

Issue Date FY: 2015 ( Subtotal = $0 )
2015	2013	NEUROCOG TRIALS INC	3211 SHANNON ROAD	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	000	3	4/7/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2013 ( Subtotal = $568,573 )
2013	2013	NEUROCOG TRIALS INC	3211 SHANNON ROAD	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	000	3	9/11/2013	NON-COMPETING CONTINUATION	$568,573
														Subtotal = $568,573

Issue Date FY: 2012 ( Subtotal = $584,321 )
2012	2012	NEUROCOG TRIALS INC	3211 SHANNON ROAD	DURHAM	NC	27707	DURHAM	USA	Mental Health Research Grants	000	2	9/11/2012	COMPETING CONTINUATION	$584,321
														Subtotal = $584,321

Grand Total All Awards = $3,398,783

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The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

Award Number: R44MH084240

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2009

PERIOD OF PERFORMANCE END DATE: 07/31/2021

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