Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
ID: 355120Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $2M

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/355120

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-223.html
Timeline
    Description

    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.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-223.html
    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.
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