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RFA-NS-28-012
Simpler.Grants.gov

Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)

National Institutes of Health (HHS-NIH11)

Up to $2,500,000
Due Oct 10, 2028
At a glance
Complex

This grant supports research into new therapies for Alzheimer's Disease-Related Dementias (ADRD) using genome editing and other biological methods. It covers the entire process from developing potential treatments to early clinical trials. This includes optimizing delivery systems, assessing how well the treatments work, and ensuring they are safe and can be produced at scale.

Who it's for: Organizations involved in medical research, particularly those focusing on Alzheimer's and related dementias. This includes universities, hospitals, and private companies that can conduct clinical trials and have the capability to develop new therapies.

More details

Likely Disqualifiers

  • Lack of experience in genome editing or biologic therapies
  • Inability to conduct clinical trials
  • Not focusing on Alzheimer's Disease-Related Dementias
  • Lack of necessary regulatory approvals
  • Insufficient infrastructure for drug development

What You May Need

  • Detailed research proposal
  • Proof of capability to conduct clinical trials
  • Regulatory compliance documentation
  • Budget plan for up to $2,500,000
  • Institutional support letters
  • Evidence of past research success
  • Collaborative agreements if applicable
  • Ethical approval for studies
  • Plan for scalable manufacturing

Cautions

  • Ensure compliance with regulatory expectations
  • Prepare for detailed reporting requirements
  • Projects must align with ADRD focus
  • Significant infrastructure may be required

Generated from official source details for readability

Eligibility

Eligible Applicant Types

Special District
County Gov
Tribal Gov
Private Higher Ed
For-Profit
School Districts
Other
State Gov
City/Township
Tribal Org
501(c)(3)
Small Business
Public Higher Ed
Nonprofit
Public Higher Ed

Additional Criteria

Eligible applicants include special district governments, county governments, federally recognized Indian tribal governments, private institutions of higher education, for-profit organizations, independent school districts, state governments, city or township governments, other Native American tribal organizations, nonprofits with and without 501(c)(3) status, small businesses, and public and state institutions of higher education. This means a wide range of entities, from universities to local governments and private companies, can apply.

Overview

Organizations involved in medical research, particularly those focusing on Alzheimer's and related dementias. This includes universities, hospitals, and private companies that can conduct clinical trials and have the capability to develop new therapies.

Likely Disqualifiers

  • Lack of experience in genome editing or biologic therapies
  • Inability to conduct clinical trials
  • Not focusing on Alzheimer's Disease-Related Dementias
  • Lack of necessary regulatory approvals
  • Insufficient infrastructure for drug development

Use of Funds

Funds can be used for developing and testing new therapies for ADRD, including optimizing treatment methods, conducting safety and efficacy studies, and preparing for clinical trials.

Total Program Funding

$6,000,000

Expected Awards

3

Cost Sharing

Not Required

Important Dates

Posted
Nov 3, 2026
Deadline
Oct 10, 2028(706 days)
Archive Date
Dec 9, 2028
Last Updated
Nov 3, 2026

Application Checklist

0/7 complete
  • Register your organization with NIH
  • Prepare a comprehensive research proposal
  • Gather all necessary regulatory documents
  • Develop a detailed budget plan
  • Secure institutional support and letters of collaboration
  • Ensure ethical approval for proposed studies
  • Plan for manufacturing and scalability

Award Range

N/A - $2,500,000

Deadline

Oct 10, 2028

Total Program Funding

$6,000,000

Official Source

Always review the official grant listing for the most accurate and up-to-date information.

View Official Listing

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