Opportunity Information: Apply for PAR 15 174
Apply for PAR 15 174
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alzheimers Drug Development Program (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866 Aging Research.
- This funding opportunity was created on Apr 2, 2015 and posted on Apr 2, 2015.
- Applicants must submit their applications by May 7, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) County governments Small businesses Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) For profit organizations other than small businesses Special district governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments.
- 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.
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Opportunity Summary:
The Alzheimers Drug Development Program (U01) is a National Institutes of Health (NIH) cooperative agreement funding opportunity designed to push promising Alzheimers disease (AD) therapeutics through the practical, development-focused steps needed to reach human testing. The core purpose is not to explore new biological theories or run discovery research, but to directly support preclinical development and early clinical development (up through initial Phase I trials) for small molecule drugs and biologic therapeutic agents intended to prevent AD, slow disease progression, or treat cognitive and behavioral symptoms associated with the disease. In other words, this program is aimed at moving a therapy from a viable lead candidate into the kind of package that can support an Investigational New Drug (IND) application and first-in-human safety testing.
The activities supported under this FOA are the kinds of milestone driven, translational tasks that typically sit between an academic proof-of-concept and a clinically testable product. Supported work can include medicinal chemistry to refine a candidate compound, pharmacokinetics (PK) studies to understand exposure and dosing behavior, and broader ADMET work (absorption, distribution, metabolism, excretion, and toxicology) to characterize safety and how the drug behaves in the body. The program also supports efficacy testing in relevant animal models, formulation development to create a stable and deliverable drug product, and chemical synthesis under Good Manufacturing Practices (GMP) to generate clinical grade material. It further covers IND enabling studies (the preclinical safety and manufacturing documentation typically required to open a clinical trial) and initial Phase I clinical testing, which generally focuses on safety, tolerability, and early human PK rather than proof of efficacy.
Just as important as what it funds is what it explicitly does not fund. This opportunity does not support basic research on underlying disease mechanisms, biomarker development efforts, medical devices, or non pharmacological interventions such as exercise programs, dietary approaches, or cognitive training. It also excludes repurposed drugs, combination therapies, and early discovery activities such as high throughput screening and hit optimization. The intent is to concentrate resources on advancing defined therapeutic candidates along a development pathway, rather than generating new targets, new screening hits, or adjunct strategies.
Administratively, the opportunity is listed as PAR 15 174 and uses the U01 mechanism, meaning it is a cooperative agreement rather than a standard grant. In practice, that implies a more collaborative structure with substantial NIH scientific or programmatic involvement compared with investigator initiated R01 style awards, often reflecting active coordination around development milestones, readiness criteria, and translational deliverables. The activity falls under the Health category with CFDA number 93.866 (Aging Research). The posted and creation date was April 2, 2015, with an original and final application closing date of May 7, 2018, and an archive date of June 7, 2018. The listed award ceiling is $1,000,000, and there is no cost sharing or matching requirement noted.
Eligibility is broad and includes many common research and development performers across the public, private, and nonprofit sectors. Eligible applicants include small businesses; for profit organizations (including those other than small businesses); nonprofit organizations (including those with and without 501(c)(3) status, other than institutions of higher education); public and private institutions of higher education; and various levels of government such as state governments, county governments, city or township governments, special district governments, independent school districts, and public or Indian housing authorities. The FOA also specifies additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, Asian American Native American Pacific Islander serving institutions (AANAPISIs), faith based or community based organizations, non U.S. (foreign) entities, regional organizations, U.S. territories or possessions, and eligible federal agencies.
For applicants, the practical takeaway is that NIH was looking for teams ready to execute a credible development plan for an AD therapeutic candidate, with work centered on the enabling studies and early clinical steps that directly support translation to humans. Projects aligned with concrete development activities (chemistry, PK/ADMET, toxicology, formulation, GMP manufacture, IND preparation, and Phase I) fit the program, while proposals centered on discovery, biomarkers, devices, lifestyle interventions, or mechanistic/basic biology do not. The full archived announcement was available through the NIH Grants Guide at the link provided in the source material.
Alzheimer's Drug Development Program (U01) - FAQs (PAR-15-174)
What is the Alzheimer's Drug Development Program (U01)?
It is a National Institutes of Health (NIH) cooperative agreement funding opportunity intended to push promising Alzheimer's disease (AD) therapeutic candidates through practical, development-focused steps needed to reach human testing. The mechanism is a U01 cooperative agreement, emphasizing milestone-driven translational work rather than discovery research.
What is the main purpose of this funding opportunity?
The core purpose is to support preclinical development and early clinical development (up through initial Phase I trials) for small molecule drugs and biologic therapeutic agents for Alzheimer's disease. The goal is to move a viable lead candidate toward an Investigational New Drug (IND) package and first-in-human safety testing.
What kinds of therapies are in scope?
The program supports small molecule drugs and biologic therapeutic agents intended to prevent Alzheimer's disease, slow disease progression, or treat cognitive and behavioral symptoms associated with AD.
What stages of development does this program support?
It supports activities from preclinical development through early clinical development, specifically up to and including initial Phase I clinical testing (typically focused on safety, tolerability, and early human pharmacokinetics rather than efficacy).
What types of work and activities can be funded?
Supported work includes milestone-driven translational tasks such as medicinal chemistry, pharmacokinetics (PK), ADMET (absorption, distribution, metabolism, excretion, and toxicology), efficacy testing in relevant animal models, formulation development, GMP chemical synthesis to produce clinical-grade material, IND-enabling studies, IND preparation-related documentation, and initial Phase I clinical testing.
Does this program fund medicinal chemistry work?
Yes. Medicinal chemistry to refine and optimize a candidate compound is explicitly listed as an eligible activity.
Does this program fund pharmacokinetics (PK) and ADMET studies?
Yes. PK studies and broader ADMET work, including toxicology, are within scope to characterize exposure, dosing behavior, safety, and how the drug behaves in the body.
Does the program support efficacy testing in animals?
Yes. Efficacy testing in relevant animal models is listed among the supported development activities.
Can formulation development be included?
Yes. Formulation development to create a stable and deliverable drug product is included as a supported activity.
Is GMP manufacturing supported?
Yes. The FOA supports chemical synthesis under Good Manufacturing Practices (GMP) to generate clinical-grade material.
Does the FOA support IND-enabling studies and IND preparation?
Yes. IND-enabling studies (preclinical safety and manufacturing documentation typically required to open a clinical trial) are explicitly covered, with the intent of building an IND-supporting package.
Does this opportunity support Phase I clinical trials?
Yes. It supports initial Phase I clinical testing, generally focused on safety, tolerability, and early human PK rather than proof of efficacy.
What is explicitly not funded under this opportunity?
The FOA does not fund basic research on underlying disease mechanisms, biomarker development efforts, medical devices, or non-pharmacological interventions (such as exercise programs, dietary approaches, or cognitive training).
Are drug repurposing projects allowed?
No. Repurposed drugs are explicitly excluded.
Are combination therapies allowed?
No. Combination therapies are explicitly excluded.
Does this FOA support early discovery activities like high-throughput screening?
No. Early discovery activities such as high-throughput screening and hit optimization are excluded, and the program is not intended for generating new screening hits or targets.
Is this program intended for basic science or mechanistic studies?
No. The stated intent is development-focused translation of defined therapeutic candidates, not exploration of new biological theories or basic research on disease mechanisms.
What does the U01 cooperative agreement mechanism imply?
A U01 is a cooperative agreement rather than a standard grant, indicating substantial NIH scientific or programmatic involvement. In practice, this often means closer collaboration and coordination around development milestones, readiness criteria, and translational deliverables compared with investigator-initiated R01-style awards.
What is the funding opportunity announcement (FOA) number and program identifier?
The opportunity is listed as PAR-15-174 and uses the U01 mechanism.
What is the CFDA number and category for this opportunity?
The activity is in the Health category with CFDA number 93.866 (Aging Research).
What is the maximum award amount (award ceiling)?
The listed award ceiling is $1,000,000.
Is cost sharing or matching required?
No cost sharing or matching requirement is noted in the provided information.
When was the FOA posted, and what were the application dates?
The posted and creation date was April 2, 2015. The original and final application closing date was May 7, 2018. The archive date was June 7, 2018.
Is this opportunity still open?
Based on the provided dates (final closing date May 7, 2018 and archive date June 7, 2018), this announcement is archived and no longer accepting applications.
Who is eligible to apply?
Eligibility is broad and includes small businesses; for-profit organizations (including those other than small businesses); nonprofit organizations (including those with and without 501(c)(3) status, other than institutions of higher education); public and private institutions of higher education; and government entities such as state, county, city or township governments, special district governments, independent school districts, and public or Indian housing authorities.
Are minority-serving institutions and community-based organizations eligible?
Yes. The FOA specifies eligibility for Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, Asian American Native American Pacific Islander-serving institutions (AANAPISIs), and faith-based or community-based organizations.
Can non-U.S. (foreign) organizations apply?
Yes. Non-U.S. (foreign) entities are listed among the eligible applicants.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included in the eligibility list.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are listed among the eligible applicants.
What kinds of project teams or proposals are a good fit for this program?
NIH was looking for teams ready to execute a credible development plan for an AD therapeutic candidate, centered on enabling studies and early clinical steps that directly support translation to humans. Projects focused on chemistry, PK/ADMET, toxicology, formulation, GMP manufacture, IND preparation, and Phase I testing align with the program intent.
What kinds of proposals would be considered out of scope?
Proposals centered on discovery research, biomarker development, medical devices, lifestyle or behavioral interventions, repurposing, combination therapies, high-throughput screening, hit optimization, or mechanistic/basic biology do not fit the stated scope.
Where was the full announcement available?
The full archived announcement was available through the NIH Grants Guide at the link referenced in the source material.
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