Notice of Special Interest (NOSI): Administrative Supplement Program to Add Fluid-based Biomarkers and APOE Genotyping to NINDS ADRD Human Subjects Research Grants
NOT-NS-24-135
Key Dates
Related Announcements
- October 9, 2020 – Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO, PA-20-272.
Issued by
Purpose
The purpose of this one-year administrative supplement is to provide support for currently active NINDSAlzheimers Disease and Alzheimers Disease Related Dementias (AD/ADRD) awards to add/include APOE genotype and fluid-based AD/ADRD biomarkers to ongoing AD/ADRD human subjects research studies and generate new data that should enhance the clinical and scientific content of the study, now and in the future via data sharing.
Background
Under theNational Plan to Address Alzheimers Disease (AD), Goal 1 is to prevent and effectively treat AD/ADRD. ADRDs include FrontotemporalDementia (FTD), Vascular Contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementias (LBD) and Multiple Etiology Dementias (MED)based on similarities in clinical symptoms and brain pathologies between these and pathological AD and/or clinical AD. Starting in 2012, the National Institute on Aging (NIA) and NINDS have held research summits to assess needs and set AD/ADRD research implementation milestones. In 2022, the NINDS led ADRD Summit resulted in ADRD research priorities, includingmultiplemilestones that address the need to better understand AD/ADRD risk, assessment, diagnosis, detection, target engagement, monitoring and patient stratification through use of biomarkers.Recently, advances in fluid-based biomarkers for AD/ADRD offer the opportunity to generate new data for AD/ADRD human subjects research projects. It is hoped that these additional AD/ADRD biomarkers will directly benefit the science of the ongoing project as well as enhance the long-term impact of the research. An important outcome of this program will be to increase the diversity of populations for which the selected biomarkers have been assessed.
Research Objectives
Administrative supplements funded under this Notice of Special Interest (NOSI) will provide funding to active NINDS AD/ADRD human subjects research studies toadd APOE genotype, fluid-based AD/ADRD biomarkers, and corresponding changes needed to study protocols and data analysis to effectively leverage biomarker and APOE genotype information. This NOSI will not support the addition of imaging-based biomarkers. As administrative supplements, the work proposed needs to be within the scope of the research that is already supported.Applicants must propose strategies, including via novel approaches, to incorporate:
- APOE genotyping and
- At least one or more but not limited to, fluid-based AD/ADRD biomarkers for:
- tau
- amyloid-β
- neurofilament light
- α-synuclein
NINDS strongly encourages applications that share the data collected, and the sharing strategy must follow the requirements of the parent award NOFO. Active human subjects NINDS AD/ADRD awards with project end dates in fiscal year 2026 or later are eligible for this program. The award may not be going into a no-cost extension in FY25. Prospective applicants are strongly encouraged to discuss their proposed aims with their program officer to verify eligibility criteria and fit within the scope of their existing award.
Only supplement applications to parent awards that have an NS designation for NIH administrative institute are eligible to apply to the NINDS for support under this NOSI.
Review Process
NINDS will conduct administrative reviews of applications.
Criteria:
- Is the parent award an NINDS AD/ADRD grant?
- Is the work proposed within the scope of the active award?
- Is the work proposed focused ondementia?
- Is the choice of assays to be included well justified and appropriate for the scientific questions?
- Is there evidence that the assays to be added will be conducted in a rigorous and standardized way using established protocols?
- Is the supplement and resulting data likely to add scientific value to the active award?
- Is an appropriate sharing strategy in place and feasible so that the data have an impact after this project is concluded?
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
- PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
All instructions in the How to Apply - Application Guide and PA-20-272must be followed, with the following additions:
- Application Due Date: November 11, 2024, by 5:00 PM local time of applicant organization.
- For funding consideration, applicants must include NOT-NS-24-109 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
- Requests may be for one year of support only and the proposed project period must be within the project period of the parent award.
- Individual requests can be no more than $150,000 in direct costs exclusive of Facilities and Administrative costs on subcontracts but cannot exceed the direct costs of the parent award and must reflect the actual needs of the proposed project.
- Awards made under this NOSI are limited to one per parent award.
- The application Abstract section should describe the proposed supplement and the Research Strategy section should include a summary or abstract of the funded parent award or project. The Research Strategy should state the relevance to the parent award and AD/ADRD, and articulate the component(s) and any specific priorities that the supplement is addressing.
- The Research Strategy section of the application is limited to 6 pages.
- Only existing awardees of NINDS AD/ADRD focused grants are eligible to apply.
- Applicants are strongly encouraged to notify the NINDS program contact supporting the parent award that a request has been submitted in response to this NOSI to facilitate efficient processing of the request.
Inquiries
Please direct all inquiries to:
Amber McCartney, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: amber.mccartney@nih.gov
