Release Date: August 5, 2011
National Institute of Neurological Disorders and Stroke (NINDS)
The National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for ancillary studies that will further our understanding of the unique clinical and biomarker signatures of premanifest Huntington's disease (HD) through coordination with the NINDS-funded Neurobiological Predictors of Huntington's Disease (PREDICT-HD) study. The PREDICT-HD study is an international 32-site observational study of persons at-risk for HD, and includes clinical and biospecimen resources from 800 premanifest HD participants and 200 healthy control subjects. Extensive clinical data including UHDRS motor examination, cognitive and neuropsychiatric assessments, and structural MRI imaging have been collected over a ten-year time frame, with a subset of these data accessible through the dbGaP website http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000222.v1.p1 . Biospecimen samples including plasma and blood are collected yearly and stored at the Coriell Institute for Medical Research biorepository.
The PREDICT-HD study cohort and database offer an unprecedented opportunity to further examine distinct aspects of premanifest HD. During this current and final period of funding for the PREDICT-HD study, the specific goals of this FOA will:
- Coordinate pilot studies within the existing infrastructure of the PREDICT-HD study
- Facilitate standardized collection and management of biospecimen resources across all sites and funded projects
- Accelerate the discovery and validation of HD biomarkers
- Promote the development of new clinical assessments and clinical trial design for premanifest HD and
- Foster and expand collaborative opportunities for all stakeholders
This FOA will encourage collaborative investigations combining expertise in imaging, proteomics, assay development, clinical trial design, genetic variant modifier analysis, and motor, neuropsychological and cognitive assessments of neurological disease. Among the areas of research encouraged in this initiative are innovative and informative clinical and biomarker assessments designed to improve the translation of existing knowledge towards efficient and effective clinical trials for the prevention and treatment of Huntington's disease.
This Notice is being provided to allow potential applicants
sufficient time to develop meaningful collaborations and responsive
projects. Investigators within and outside of the PREDICT-HD study will
be eligible to apply. Applications proposing additional clinical assessments
must complete these studies within the remaining 3 year time frame (September
1, 2011-August 31, 2014) for PREDICT-HD. Based on the infrastructure available
through PREDICT-HD, it is anticipated that responsive applications will have
direct costs of $500k or less per year.
The FOA is expected to be published in October 2011 with an initial application
receipt date in December, 2011.
APPLICATIONS ARE NOT
BEING SOLICITED AT THIS TIME.
Please direct all inquiries to:
Margaret Sutherland, PhD
Program Director, Neurodegeneration Cluster
NINDS
6001 Executive Blvd, NSC 2222
Bethesda, MD 20892
Phone: 301-496-5680
EMAIL : sutherlandm@ninds.nih.gov
and Human Services (HHS)
