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INCLUDE Project: Clinical Trials Phased Awards for Down syndrome Research (R61/R33 Clinical Trial Required)

National Institutes of Health

Program funding

$3,000,000

Opportunity #
RFA-OD-27-005
Agency
National Institutes of Health
ALN (CFDA)
93.395, 93.866, 93.839, 93.838, 93.846, 93.840, 93.173, 93.310, 93.847, 93.837, 93.233, 93.350, 93.865
Status
posted
Posted
May 13, 2026
Closes
Jun 15, 2028
Funding instrument
Grant
Category
Health
Cost sharing required
No

Who can apply

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Synopsis

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. The purpose of this Notice of Funding Opportunity (NOFO) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this NOFO may not exceed five years. This NOFO provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition to clinical trial support (R33) of up to three years, although the total duration of the award may not exceed five years. This NOFO requires measurable R61 milestones.

Contact

National Institutes of Health · DownSyndromeINCLUDE@mail.nih.gov

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