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

Forecasted Federal grant Posted

Opportunity number
RFA-AG-28-009
Agency
Applications expected due
Award size
Not on record

Opportunity facts

Expected posting
Assistance listings
Funding instrument
Cooperative Agreement
Category
  • Health
Eligible applicants
  • Non-501(c)(3) Nonprofits
  • Independent School Districts
  • State Governments
  • Tribal Organizations (Not Federally Recognized)
  • Special District Governments
  • Higher Education Inst. (Public)
  • Other
  • Higher Education Inst. (Private)
  • County Governments
  • Small Businesses
  • 501(c)(3) Nonprofits
  • City/Township Governments
  • Tribal Governments (Federally Recognized)
  • For Profit Organizations
  • Public or Indian Housing Auth.
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

The National Institute on Aging (NIA) intends to publish a Notice of Funding Opportunity to solicit cooperative agreement applications for preclinical and early-stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer's disease, slow its progression, or treat cognitive and behavioral symptoms; applications are not being solicited at this time. This forecast notice allows potential applicants to develop meaningful collaborations and responsive projects before the NOFO posts.

Eligible applicants include non-501(c)(3) nonprofits, 501(c)(3) nonprofits, public and private higher education institutions, state and local governments, tribal governments (both federally and non-federally recognized), special district governments, city and township governments, county governments, small businesses, for-profit organizations, public or Indian housing authorities, Indian/Native American tribal governments, eligible federal agencies, U.S. territories or possessions, faith-based or community-based organizations, and regional organizations.

The program supports preclinical drug development activities conducted in applicant laboratories or in collaboration with contract research organizations. NIA aims to expand the number of investigational new drug candidates across emerging therapeutic targets, broaden the therapeutic pipeline for Alzheimer's disease with candidates targeting multiple disease mechanisms suitable for mono-therapy or combination therapy, and enable precision medicine approaches to drug development.

Awards will use the U01 activity code and operate as cooperative agreements. The program operates under Assistance Listing 93.866 (Aging Research). Review timelines for NIA grants typically run six to nine months from application to funding decision. Applications receive initial scientific review by non-NIH scientists and secondary review by the National Advisory Council on Aging. No specific award ceiling, floor, or expected number of awards is announced in this forecast notice.

Forecast synopsis

The National Institute on Aging (NIA) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose pre-clinical and early-stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that aim to prevent Alzheimer's disease (AD), slow its progression, or treat its cognitive and behavioral symptoms.

Through the NOFO, NIA is continuing the Alzheimer's Drug-Development Program (ADDP) with the aim of catalyzing drug development for AD. The ADDP is designed to provide funding support to academic and biotech researchers for preclinical drug development activities that can be conducted in their own laboratories or conducted in collaboration with contract research organizations that specialize in preclinical drug development activities. By supporting the most challenging and costly steps of drug development and seamlessly connecting preclinical drug development and first-in-human testing for drug candidates, the ADDP program seeks to:

  • Continue to expand the number of investigational new drug candidates for a portfolio of emerging therapeutic targets;
  • Continue to expand the therapeutic pipeline for AD with drug candidates targeting multiple underlying disease mechanisms that can be used as mono-therapy or as part of combination therapy; and
  • Enable a precision medicine approach to AD drug development.

The NOFO will utilize the U01 activity code. Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

Eligibility

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;

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