Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Require
About
The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials to streamline the early-stage evaluation of promising pharmacological interventions for Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD). Candidate interventions evaluated through this program, which can include small molecules or biologics for example, must engage non-amyloid/non-tau mechanisms and aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum from pre-symptomatic to more severe stages of disease. This NOFO uses the UG3/UH3 phased award mechanism and proposals must include prespecified, go/no-go safety and tolerability milestones that gate the advance from phase 1 to latter stages of clinical development.
The Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) grant program supports researchers and organizations developing novel therapeutic agents for Alzheimer's Disease (AD) and Alzheimer's Disease-related Dementias (ADRD). This program is designed for applicants seeking to streamline early-stage clinical evaluation by bundling Phase 1 and Phase 1b/2a clinical trial protocols. The initiative focuses on pharmacological interventions targeting non-amyloid/non-tau mechanisms to address cognitive and neuropsychiatric symptoms across the disease spectrum, from pre-symptomatic to severe stages. Eligible candidates may develop small molecules or biologics. Using the UG3/UH3 phased award mechanism, this program requires proposals to include prespecified, go/no-go safety and tolerability milestones that gate progression from Phase 1 to later-stage clinical development. This funding opportunity is ideal for academic institutions, research organizations, biotech companies, and eligible organizations committed to advancing innovative treatments for AD and related dementias. The phased approach reduces development timelines and improves resource efficiency for promising therapeutic candidates.
Funding Facts
● Applications openDeadline
November 19, 2026
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by cycle
Deadline
2026-11-19
Grant Type
federal
Application Cycle
Annual
Best For
Research institutions, biotech companies, HBCUs, minority-serving institutions, and organizations developing novel AD/ADRD therapeutics
Eligibility
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 Govern
Frequently Asked Questions
Who is eligible for the Seamless Early-Stage Clinical Drug Development grant?
Eligible applicants include academic and research institutions, HBCUs (Historically Black Colleges and Universities), Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs (Asian American Native American Pacific Islander Serving Institutions), faith-based and community-based organizations, eligible federal agencies, and Indian/Native American Tribal Governments. For a complete and current list of eligible applicants, consult the official funding opportunity announcement on the NIH website.
How much funding does this grant program provide?
Specific funding amounts are not listed in this summary. Award amounts vary by funding cycle and proposal scope. Visit the official Notice of Funding Opportunity (NOFO) on the NIH website for current funding estimates and budget details.
How do I apply for the Seamless Early-Stage Clinical Drug Development grant?
Applications should be submitted through the official NIH grant submission system. Proposals must follow the UG3/UH3 phased award mechanism requirements and include bundled Phase 1 and Phase 1b/2a protocols with prespecified go/no-go safety and tolerability milestones. Visit the official NOFO and NIH Grants.gov website for detailed application instructions, required forms, and submission deadlines.
What can this grant funding be used for?
Funding supports the development and clinical evaluation of novel pharmacological interventions (small molecules or biologics) for Alzheimer's Disease and related dementias. Candidate agents must target non-amyloid/non-tau mechanisms and address cognitive and/or neuropsychiatric symptoms. The grant specifically funds bundled Phase 1 through Phase 1b/2a clinical trial protocols designed to streamline early-stage drug development with integrated safety and tolerability assessments.
Last updated: July 5, 2026