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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)

US · MD · Bethesda National Institutes of Health (NIH) grant open #PAR-25-226
Response due Nov 19, 2026 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting applications for seamless early-stage clinical drug development spanning Phase 1 through Phase 2a for novel therapeutic agents targeting Alzheimer's Disease (AD) and AD-related dementias (ADRD). The UG3/UH3 cooperative agreement mechanism requires an integrated clinical trial component, covering the full continuum from initial safety and tolerability studies into early efficacy assessment. Applicants must propose novel therapeutic agents and demonstrate a clear clinical development pathway across the AD/ADRD spectrum. This is a multi-year funding opportunity open from November 2024 through November 2026.

What they want

Awardees will conduct seamless, integrated early-stage clinical drug development programs progressing from Phase 1 (safety, tolerability, pharmacokinetics/pharmacodynamics) to Phase 2a (preliminary efficacy/proof-of-concept) for novel therapeutic agents addressing Alzheimer's Disease and AD-related dementias. Work must include a required clinical trial component consistent with the UG3 (milestone-driven planning/early execution) and UH3 (full trial execution) cooperative agreement structure. The spectrum of AD and ADRD conditions must be addressed, and all proposed agents must be novel therapeutics.
Deliverables
  • Phase 1 clinical trial data (safety, tolerability, PK/PD)
  • Phase 2a clinical trial data (preliminary efficacy/proof-of-concept)
  • Milestone reports per UG3 requirements
  • Full clinical trial execution and reporting per UH3 requirements
Technical requirements
  • Seamless Phase 1 to Phase 2a clinical trial design
  • Novel therapeutic agent targeting AD and/or ADRD
  • Clinical trial required (UG3/UH3 mechanism)
  • UG3 milestone-driven planning and early execution phase
  • UH3 full clinical trial execution phase
  • Coverage of the spectrum of Alzheimer's Disease and AD-related dementias

How they evaluate

Submission: Grants.gov federal grants portal (electronic submission)

Eligibility & certifications

SAM.gov registration (federal grants requirement)NIH human subjects research complianceIRB approval for clinical trialsIND (Investigational New Drug) application with FDA

Risks & flags

  • Extremely long open window (2 years) may indicate rolling review with competitive disadvantage for late applicants
  • UG3/UH3 milestone-gated structure means UH3 funding is contingent on UG3 performance — de facto two-stage filter that may favor established clinical research organizations
  • No dollar value disclosed, making budget benchmarking difficult for new applicants

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Health Care & Social Assistance
NAICS 621511
US market size
$2.7T
Typical award
$50K – $100M
Typical buyers
VAHHSDoD MHSIHS
Commonly required
Joint CommissionCMS

Sector-level estimate — full code lookup not yet in catalog.

Seamless Early-Stage Clinical Drug Develop…
Due Nov 19
Onboard ↗