NOT-NS-18-092: Notice of Intent to Publish a Funding Opportunity Announcement for Post-Stroke VCID in the United States Including in Health Disparities Populations (U19 Clinical Trial Not Allowed)

Notice of Intent to Publish a Funding Opportunity Announcement for Post-Stroke VCID in the United States Including in Health Disparities Populations (U19 Clinical Trial Not Allowed)

Notice Number: NOT-NS-18-092

Key Dates

Release Date: September 13, 2018
Estimated Publication Date of Funding Opportunity Announcement: November 01, 2018
First Estimated Application Due Date: March 05, 2019
Earliest Estimated Award Date: September 30, 2019
Earliest Estimated Start Date: September 30, 2019

Related Announcements
None

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS), as a part of an ongoing collaboration with the National Institute on Aging (NIA) on AD/ADRD research, intends to publish a Funding Opportunity Announcement (FOA) responsive to vascular contributions to cognitive impairment and dementia (VCID) milestones in the National Plan to Address Alzheimer’s Disease. The FOA will invite applications for a large prospective clinical research study to determine the specific subsets of stroke events that predict cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations, and what additional clinical factors and comorbidities along the AD/ADRD spectrum may causally synergize with stroke to result in (or prevent) cognitive impairment and dementia outcomes.

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 November 2018, with an expected application due date in April 2019. This FOA will utilize the U19 activity code, which supports a multi-component research program directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary approach. Details of the planned FOA are provided below.

Research Initiative Details

The goals of this initiative are to determine the relationship between specific subsets of stroke events and subsequent cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations; to identify additional clinical factors and comorbidities that may affect these relationships; and to contribute to development and validation of clinical-trial ready diagnostic and progression biomarkers for post-stroke dementia. It is expected that the study design will also allow for determination of interrelationships (cross-sectional and longitudinal) among the stroke event, cerebrovascular and cardiovascular disease and risk factors including inflammation, dementia-relevant genetic variants and mutations previously associated with Alzheimer's disease, cognitive trajectories including decline and resistance to decline, as well as amyloid and tau biomarkers of Alzheimer’s pathology during life.

NIH expects that the goals of this initiative will benefit from a collaborative network of cores and sites with the expertise, capacity, and access to stroke populations in order to achieve adequate statistical power. NIH strongly encourages applicants to form multidisciplinary teams that consist of both clinical and non-clinical scientists with expertise in stroke, VCID, dementia, statistical design and analysis, population-based clinical research, and health disparities research. This multi-disciplinary team should have the expertise needed to execute the research strategy. NIH expects the multi-component application will include scientific cores, including an Administrative and Study Management Core; Data Coordinating Center; Recruitment and Retention Core; and Imaging, Biorepository and Laboratory Core; as well as clinical sites. It is expected that the project will be phased, with an initial protocol refinement and start-up phase followed by an implementation phase.

Applicants are encouraged to leverage existing resources for VCID and stroke research, including but not limited to, MarkVCID, StrokeNet, established stroke cohorts, and other dementia centers and resources.

Funding Information

Estimated Total Funding TBD
Expected Number of Awards 1
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.853; 93.866

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Roderick A. Corriveau, PhD

National Institute of Neurological Disorders and Stroke (NINDS)

301-496-5680

roderick.corriveau@nih.gov

Claudia Moy, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: claudia.moy@nih.gov