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 Required)

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.

Program Details

National Institutes of Health is a federal agency that offers the 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 Required) grant program to support eligible programs and projects. This funding opportunity is available nationally and is administered by National Institutes of Health through Grants.gov. Organizations seeking funding for eligible programs and projects should review the details below and confirm their eligibility before preparing an application.

Eligibility

Eligible applicants include for-profit businesses, educational institutions, eligible organizations, and government agencies and municipalities. Organizations that meet the eligibility criteria are encouraged to apply and to review the full program guidelines before submission. Because eligibility rules and funding priorities can change between cycles, applicants should always confirm the current requirements with National Institutes of Health or on Grants.gov before investing time in an application.

Funding and Timeline

The application deadline is November 19, 2026 (114 days remaining). Applicants should allow sufficient time to gather required documentation, including organizational information, project descriptions, budgets, and supporting materials as specified in the program guidelines. Submitting a complete application well ahead of the deadline reduces the risk of disqualification on technical or administrative grounds.

Program Focus

This grant supports eligible programs and projects. This grant is associated with NAICS industry classifications: 541714, 621111, 621112, 622. Organizations operating in these sectors are encouraged to review eligibility. Funded projects are expected to demonstrate measurable outcomes aligned with the program's stated objectives. Grant recipients may be required to submit progress reports and final evaluations as a condition of the award, and to retain records for audit and compliance purposes.

How to Apply

Eligible organizations can apply through Grants.gov. Create a free organization profile on GrantRegister to see whether this grant matches your organization's NAICS code, entity type, location, and focus area, and to receive a weekly digest of every open grant you qualify for.

GrantRegister maintains a complete, authoritative registry of US federal, state, and foundation grant opportunities — matched automatically to your organization profile and delivered every Monday.

Eligibility

• Funded by NIH

Award details

Applications close on November 19, 2026 (114 days remaining).

Categories

Not categorized