Notice of Special Interest: Administrative Supplements for Connecting Pre-mortem Clinical Information with Post-Mortem Brain Analysis
Notice Number:
NOT-NS-21-001

Key Dates

Release Date:

August 27, 2020

First Available Due Date:
October 26, 2020
Expiration Date:
June 29, 2021

Related Announcements

PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The Lewy Body Dementias (LBD) are frequently misdiagnosed or underdiagnosed during life, and despite the development of diagnostic criteria at multiple expert consensus conferences, the gold standard for diagnosis remains post-mortem brain analysis. Improvement in diagnostic accuracy during life, and the development of good quality diagnostic biomarkers, would be greatly facilitated if comprehensive, longitudinal clinical and biological data obtained on patients during life were regularly linked with detailed post-mortem brain examination.  In response to recommendations from the Alzheimer's Disease Related Dementias (ADRD) Summits convened by the NINDS in 2013, 2016, and 2019, longitudinal clinical data and biospecimens are being collected from patients with LBD and shared with the research community through the Parkinson’s Disease Biomarker Program (PDBP).  The PDBP is an NINDS-funded resource that collects standardized clinical data and biospecimens longitudinally on patients with Parkinson's Disease (PD) and PD-related disorders (including LBD) with the goal of accelerating the pace of biomarkers research. The PDBP currently has data and biospecimens on about 1900 subjects, some of whom have gone to autopsy, though relatively little post-mortem data on these subjects is available in PDBP at this time.

This NOSI encourages researchers with extensive pre- and post-mortem data on patients with LBD to apply for supplemental funds to be used for the purpose of adding this data to the existing NINDS PDBP repository.  Supplements may be requested by:

  1. Researchers who have previously contributed clinical and biospecimen data to the PDBP on patients with LBD while alive, and who wish to add the post-mortem autopsy data they have collected on the same patient(s) after their death.  
  2. Researchers who have never contributed data to the PDBP DMR, but who have comprehensive longitudinal clinical data, culminating in post-mortem brain autopsy data, on subjects with LBD who wish to add their data to PDBP for sharing with the research community.  

All data must be entered using PDBP standardized forms, which are listed on the PDBP website. For post-mortem brain data collection, the PDBP uses the National Alzheimer's Coordinating Center Neuropathology Data Form. Researchers who are new to the PDBP program must document that subjects have been appropriately consented for their data to be broadly shared with the research community. Funds may be requested to support staff who will input data using standard PDBP formats and who will work with PDBP staff to ensure that the data entered is accurate and of good quality. Staff time must be fully justified in the context of the amount of data which the applicant is proposing to upload.

Requests for supplemental funding to support the performance of brain autopsies will not be considered under this announcement.

 

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

  • PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

  • Application Due Date(s) – October 26, 2020, February 26, 2021, June 28, 2021, by 5:00 PM local time of applicant organization.
  • For funding consideration, applicants must include NOT-NS-21-001 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 may not exceed $100,000 in direct costs.
  • The Research Strategy section of the application is limited to 6 pages.
  • Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Debra Babcock, PhD, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: dbabcock@mail.nih.gov


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