Small Vessel VCID Biomarker Validation Consortium Sites (U01)(Clinical Trials Not Allowed)

T?o invite applications to an open competition to be one of up to 7 supported sites in the next phase of the NINDS small vessel vascular contributions to cognitive impairment and dementia (VCID) biomarkers consortium. The original consortium, established under RFA-NS-16-019 and RFA-NS-16-020, pursued initial stages of multi-site validation of 11 candidate imaging-based and fluid-based biomarkers. The primary objective of the next 5 years is to carry out comprehensive multi-site clinical validation of up to six of these 11 biomarkers to be selected by the NINDS in a process separate from this FOA. The focus will be validation in longitudinal studies of diverse all-comers populations that are typical in clinical settings in the United States. The network of sites will provide scientific expertise and experimental infrastructure to pursue these goals synergistically including with the Coordinating Center (RFA-NS-21-004). At the conclusion of clinical validation each biomarker will have a designated category and context of use as defined by the FDA and a finalized public protocol that describes all details needed to utilize the biomarker. The sites will drive the consortium scientifically and contribute administratively to comprehensive rigorous clinical validation of biomarkers for future clinical trials, including in large phase III trials, and for generating scientific breakthroughs in our understanding and treatment of VCID.