Notice Number: NOT-NS-14-031
Update: The following update relating to this announcement has been issued:
- July 29, 2014 - See Issuance of RFA-NS-14-012.
Key Dates
Release Date: May 29, 2014
Estimated Publication Date of Announcement: July, 2014
First Estimated Application Due Date: November, 2014
Earliest Estimated Award Date: June, 2015
Earliest Estimated Start Date: June, 2015
None
Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
Purpose
The National Institute of Neurological Disorders and Stroke (NINDS) will support a longitudinal clinical study to detect and define the progression of chronic traumatic encephalopathy (CTE) using neuroimaging tools, such as MRI and PET, as well as genetics, cognitive and behavioral tests, CSF and blood biomarkers.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOA is expected to be published in the summer of 2014 with an expected application due date in fall of 2014.
This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.
Research Initiative Details
The purpose of this initiative is to detect, characterize and measure the progression of neurodegeneration in individuals with a probable or possible diagnosis of chronic traumatic encephalopathy (CTE) using brain imaging and other biomarkers. The overall goals are increased knowledge concerning the neurological mechanisms and ways to detect CTE as it evolves over a 3 - 5 year period and the development of a consensus diagnosis to inform clinical trials aimed at preventing or slowing disease progression in the future.
The research objectives are:
1) to collect and analyze high quality data such as MRI and PET, genetics, cognitive tests, CSF and blood biomarkers to detect and characterize the neurodegenerative changes and progression of CTE over a 3 - 5 year period; and
2) to develop consensus criteria for the clinical diagnosis and staging of CTE.
The study team should include the expertise necessary to recruit and follow a relevant study cohort that would include individuals with a "probable" and "possible" diagnosis of CTE and appropriate controls. In addition, the multidisciplinary team should be able to collect and analyze high quality data such as MRI and PET, genetics, cognitive tests, CSF and blood biomarkers to detect and define CTE. The study must include relevant TBI Common Data Elements and comply with the data sharing policies of the FITBIR Informatics System. If new data elements are needed for CTE, the investigators are expected to work with the NINDS Common Data Elements (CDE) Project to develop them (see http://www.nindscommondataelements.org/).
Specific Areas of Research Interest
Areas of interest include but are not limited to:
- Advanced imaging studies, including high field MRI scans, tau-radioligand and/or metabolic PET studies aimed at defining the regional distribution and other characteristic features of CTE in high-risk, symptomatic individuals with "possible" or "probable" CTE.
- A qualitative and quantitative assessment of the progression of the neurodegeneration in symptomatic, individuals considered to be at high risk for CTE over a 3 - 5 year period
- Development and/or validation of clinical tools to make a "possible" and "probable" diagnosis of CTE and to develop sensitive and specific biomarkers to track the progression over time that may inform future therapeutic trials.
- Clinical studies to advance knowledge about the pathophysiological mechanisms of CTE and its progression.
- Identification of risk factors for CTE.
- Investigation of the temporal correspondence between the neurodegenerative changes and the clinical signs and symptoms of CTE.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Inquiries
Please direct all inquiries to:
Ramona Hicks, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
Email: hicksra@mail.nih.gov
and Human Services (HHS)
