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

National Institutes of Health

posted

Award ceiling

Award floor

Posted

May 13, 2026

Closes

Jun 15, 2028

Location eligibility

No specific state restriction found in this listing — check the full opportunity for details.

Categories: Health

Eligible applicants: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Public and State controlled institutions of higher education, Private institutions of higher education, State governments, Public housing authorities/Indian housing authorities, City or township governments, Native American tribal organizations (other than Federally recognized tribal governments), County governments, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Special district governments, Others (see text field entitled "Additional Information on Eligibility" for clarification), Native American tribal governments (Federally recognized), Small businesses, Independent school districts, For profit organizations other than small businesses

Description

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.

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