Cooperative AgreementPostedDiscretionary

Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)

National Institutes of Health
PAR-24-223
Application Deadline
Nov 5, 2027
541 days left
Days Remaining
541
Until deadline
Award Ceiling
$1,500,000
Total Program Funding

Grant Opportunity Analysis

The National Institutes of Health (NIH) is offering funding through the Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) to support the preclinical and early-stage clinical development of innovative drug candidates aimed at preventing, slowing, or treating Alzheimer's disease (AD). This program specifically seeks proposals for activities such as medicinal chemistry, pharmacokinetics, biomarker development, and initial Phase I clinical testing, with an emphasis on rigor, reproducibility, and diversity in clinical trial participation. As the U.S. faces a projected increase in AD cases, this funding opportunity is crucial for fostering advancements in treatment solutions while ensuring compliance with regulatory pathways for FDA approval. Interested applicants can submit proposals starting January 3, 2025, with a funding ceiling of $1.5 million and a project duration of up to five years for early-stage projects. For further inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov.

Eligible Applicants

Others
Additional Eligibility Information

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 Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not 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.

Grant Documents

1 Files
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AI Summary
The National Institutes of Health (NIH) is reissuing the Alzheimer's Drug Development Program (ADDP) aimed at fostering innovative drug development for Alzheimer’s disease (AD). Funding under the U01 Research Project – Cooperative Agreements will support activities for preclinical and early-stage clinical development of new small-molecule and biologic candidates that can prevent, slow, or treat AD symptoms. Applications can be submitted starting January 3, 2025, with a project duration of up to five years for early-stage projects and four years for late-stage projects. Key funding activities include medicinal chemistry, pharmacokinetics, development of biomarkers, and initial Phase I clinical testing. Applicants are encouraged to align their projects with the NIH guidance on rigor and reproducibility, with an emphasis on diversity and inclusion in clinical trial participation. The application process requires compliance with extensive guidelines, detailed planning, and engagement with regulatory pathways to generate candidates eligible for FDA approval. The program aims to address the projected increase in AD cases in the U.S. and catalyze innovation in treatment solutions while ensuring a commitment to quality, compliance, and comprehensive evaluation of drug development efforts.

Related Grant Opportunities

Project Timeline

postedOriginal Opportunity PostedJun 25, 2024
deadlineApplication DeadlineNov 5, 2027
expiryArchive DateDec 11, 2027

Funding Details

Award Ceiling
$1,500,000
No cost sharing required

Agency & Classification

Agency
National Institutes of Health(HHS-NIH11)
Funding Category
Health
Funding Instrument
Cooperative Agreement

Grantor Contact

CFDA Numbers

93.866

Official Sources