The Placebo-Control Reminder Script in Depression and Psychosis Trials: An Antidote for the Placebo and Nocebo Response

Presented at the ASCP Annual Meeting May 29-31,2020 Virtual Conference

Depression and psychosis clinical trials share a crucial commonality of perpetually and alarmingly high placebo and nocebo responses. At ASCP in May 2019, Cohen, et al. presented data indicating that the Placebo-Control Reminder Script (PCRS) significantly reduced the placebo effect among subjects in a major depressive episode (MDE). Since then, the same study design, was applied among subjects with a psychotic disorder. This poster presents these data and the combined results from both populations.

Download Poster

Wearable Insoles for the Real-Time Capture of Gait Measures: Preliminary Feasibility and Validity Data in Older Adults With and Without Subjective Cognitive Decline

Presented at the ASCP Annual Meeting May 29-31,2020 Virtual Conference

Integration of wearable devices into regulated clinical trials for the assessment of cognition and functioning continues to be a topic of growing interest. If appropriately implemented, measurements from validated wearable technologies have the potential to revolutionize the conduct of clinical trials by facilitating the development of site-less clinical trial designs. In order to be truly informative, however, endpoints collected by these devices must undergo the same clinical and technological validation process required by other currently accepted tools. This poster presents preliminary data from an ongoing study examining the reliability of industry-grade pressure sensing insoles for the real-time capture of gait measures in older adults, and the relationship between gait measures and standard measures of cognition and functioning.

Download Poster

Translation and cultural adaptation of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) to measure performance-based functioning in global clinical trials in German, Italian, Russian, Polish, and Spanish for US

Presented at the ASCP Annual Meeting May 29-31,2020 Virtual Conference

The VRFCAT is currently used in industry trials across diverse CNS indications including major depression and Parkinson’s disease. In order to meet a growing need for culturally appropriate performance-based assessments of functioning in global clinical trials, we recently completed translation and cultural adaptation of the VRFCAT for use in Italian, Polish, Russian, German, and Spanish for the US.This poster describes the methods used for professional translation and cultural adaptation of the VRFCAT, and results from the cognitive debriefing and pilot testing conducted at in-country investigational sites.

Download Poster

The Virtual Reality Functional Capacity Assessment Tool (VRFCAT): A Progress Report on Its Development in the FDA Clinical Outcome Assessment Qualification Program

Presented at the ASCP Annual Meeting May 29-31,2020 Virtual Conference

The FDA has guided drug developers focused on cognitive improvement to demonstrate not only basic improvement on cognitive endpoints, but also improvement on a co-primary measure of functional capacity. The VRFCAT is a computer based virtual-reality measure of functional capacity. Our application for the VRFCAT has officially been accepted into the the FDA’s Clinical Outcome Assessment (COA) Qualification Program. This program is intended to qualify drug development tools that can be relied on the have a specific interpretation in any drug development program and regulatory review. The poster summarizes the progress made to date towards supporting a formal qualification package to the FDA.

Download Poster

Utility of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Parkinson’s Disease

Presented at AD/PD Meeting April 2-5, 2020 Virtual Conference

Regulatory agencies are increasingly focused on measures of meaningful functional improvement to assess the outcome of symptomatic and disease modifying therapies. The Virtual Reality Functional Capacity Tool (VRFCAT) is a digital tablet-based instrument that assesses proficiency for performing real world tasks in a highly realistic environment. The present study examines feasibility and utility for evaluating functioning with the VRFCAT in patients with mild to moderate Parkinson’s disease.

Download Poster

 

The Virtual Reality Functional Capacity Assessment Tool (VRFCAT): Data in Support of Accepted Application for the FDA Clinical Outcome Assessment Qualification Program

Presented at the International Society for CNS Clinical Trials and Methodology (ISCTM) Scientific Meeting held February 19-21, 2020 in Washington, DC

The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is a computer based virtual-reality measure of functional capacity. The FDA accepted VRFCAT into the Clinical Outcome Assessment (COA) Qualification Program after reviewing the development process and extensive quantitative evidence supporting its clinical utility.

Download Poster