Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U01 Clinical Trial Optional)
Funding
Not specified
Deadline
--
Days
--
Hrs
--
Min
--
Sec
Mar 05, 2026
Posted Nov 14, 2024 (462 days ago)
Closes Mar 5, 2026 (in 13 days)
Grant Details
Opportunity Number
PAR-25-209
CFDA / ALN
93.866
Opportunity Category
Discretionary (D)
Funding Category
Health (HL)
Funding Instrument
Cooperative Agreement (CA)
Cost Sharing
No Cost Sharing (No)
Eligibility
State governments (00)
County governments (01)
City or township governments (02)
Special district governments (04)
Independent school districts (05)
Public and State controlled institutions of higher education (06)
Native American tribal governments (Federally recognized) (07)
Public housing authorities / Indian housing authorities (08)
Native American tribal organizations (11)
Nonprofits having a 501(c)(3) status with the IRS (12)
Nonprofits without 501(c)(3) status (13)
Private institutions of higher education (20)
For-profit organizations other than small businesses (22)
Small businesses (23)
Others (25)
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Description
The goal of this Notice of Funding Opportunity (NOFO) is to accelerate the establishment ofeffective and reliable biomarkers of Alzheimers disease (AD) and AD-related dementias (ADRD) for usein therapy/medical product discovery and development, clinical trials and/or clinical practice. Specifically, this NOFO willsupport analytical and/or clinical validationof a biomarker, composite biomarker or biomarker signature, withrigor comparable with the expectations described in the Food and Drug Administration (FDA)Biomarker Qualification Program (BQP) or recommended by other FDA regulatory pathways.
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