Cooperative Agreement U01FD008424

The U.S. Food and Drug Administration (FDA), through the 93.103 FDA Research grant program, awarded a $249,984 Cooperative Agreement to The Critical Path Institute (C-Path) to develop a Qualification Plan for the Virtual Reality Functional Capacity Assessment Tool - Short List (VRFCAT-SLX). The goal is to qualify the VRFCAT-SLX as a publicly available performance outcome measure for assessing cognition-dependent day-to-day functioning in clinical trials for people with biomarker-positive, clinical stage 2 and 3 Alzheimer's disease. The project involves convening an advisory panel, preparing a quantitative evidence generation strategy, developing the Qualification Plan, and submitting it to the FDA to support the tool's qualification. This effort aims to fill a critical gap in measuring day-to-day functioning in Alzheimer's disease treatment trials. The federal award has a period of performance from Sep 1, 2024 to Aug 31, 2026.