Opportunity Information: Apply for RFA AG 13 016
Apply for RFA AG 13 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Alzheimers Disease Phase I Clinical Trials (R01)" 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 Dec 12, 2012 and posted on Oct 15, 2012.
- Applicants must submit their applications by Jan 14, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $800,000.00 in funding.
- Eligible applicants include: Public housing authorities/Indian housing authorities County governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) State governments Special district governments For profit organizations other than small businesses City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses Public and State controlled institutions of higher education Native American tribal governments (Federally recognized).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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 Institutions) are 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.
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Opportunity Summary:
The Alzheimers Disease Phase I Clinical Trials (R01) funding opportunity (RFA-AG-13-016) was a discretionary grant program from the National Institutes of Health focused specifically on supporting Phase I, first-in-human clinical studies of promising therapeutic candidates for Alzheimers disease. The central purpose was to help move potential treatments from preclinical or translational readiness into initial human testing, with an emphasis on generating early clinical evidence about how a candidate behaves in people. In practical terms, the initiative targeted the earliest stage of clinical development, where the main questions are whether the intervention shows expected metabolic and pharmacologic activity in humans, how the body processes the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics), including biologics as well as small-molecule drugs.
The research scope, as described, centers on Phase I clinical trials that evaluate metabolic and pharmacological actions in humans rather than later-stage efficacy trials. That typically means studies designed to establish foundational clinical parameters such as dosing ranges, tolerability, safety signals, and evidence that the intervention engages intended biological pathways or produces measurable downstream effects consistent with its proposed mechanism. Because the announcement highlights "first in human studies" and "first stage clinical trials," it is aimed at generating the kind of early human data that can justify and de-risk progression to Phase II testing, where proof-of-concept and preliminary efficacy questions become more central.
Administratively, this opportunity used the NIH R01 grant mechanism and was categorized under the Health funding activity area, with the CFDA listing of 93.866 (Aging Research). The program did not require cost sharing or matching. NIH estimated a total of $4,000,000 in funding available under the announcement, and the maximum award amount (award ceiling) was listed as $800,000. Key dates indicate the announcement was posted on October 15, 2012, created on December 12, 2012, and closed in January 2013 (original closing date January 13, 2013, with a current closing date of January 14, 2013). The archive date was February 14, 2013, meaning it is no longer an active solicitation but remains available as a record of the program.
Eligibility was broad and included a wide range of domestic and international entities. Eligible applicants encompassed federal, state, county, city/township, and special district governments; public and state-controlled and private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; nonprofits both with and without 501(c)(3) status (with the noted exception category relating to institutions of higher education); and for-profit organizations other than small businesses, as well as small businesses themselves. Additional eligible categories explicitly included faith-based and community-based organizations, historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, U.S. territories or possessions, regional organizations, and eligible federal government agencies. The announcement also allowed non-U.S. participation: non-domestic (foreign) organizations and foreign institutions could apply, non-domestic components of U.S. organizations were eligible, and foreign components were allowed as defined in the NIH Grants Policy Statement.
For applicants seeking more detail, the opportunity referenced an official NIH guide link to the full announcement (http://grants.nih.gov/grants/guide/rfa files/RFA AG 13 016.html). For technical access issues, the contact point listed was the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV), including help if the full announcement could not be accessed electronically or if there were problems linking to the funding notice.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This was the Alzheimer's Disease Phase I Clinical Trials (R01) funding opportunity, RFA-AG-13-016, offered by the National Institutes of Health (NIH) as a discretionary grant program. It focused on supporting Phase I, first-in-human clinical studies of promising therapeutic candidates for Alzheimer's disease.
What was the main goal of the program?
The central purpose was to help move potential Alzheimer's treatments from preclinical or translational readiness into initial human testing, with an emphasis on producing early clinical evidence about how a candidate behaves in people.
What type of studies did it support?
The scope centered on Phase I clinical trials, particularly first-in-human and first-stage clinical trials. These studies were intended to evaluate metabolic and pharmacological actions in humans rather than later-stage efficacy testing.
Did this opportunity support Phase II or later efficacy trials?
Based on the description provided, the emphasis was on Phase I (earliest clinical development) questions rather than later-stage efficacy trials. The intent was to generate early human data that could justify and reduce risk for progression to Phase II testing.
What kinds of interventions were included?
The announcement covered promising therapeutic candidates for Alzheimer's disease, including biologics as well as small-molecule drugs.
What clinical questions were Phase I trials expected to address?
The described Phase I focus included questions such as whether the intervention shows expected metabolic and pharmacologic activity in humans, how the body processes the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics). It also emphasized establishing foundational parameters such as dosing ranges, tolerability, safety signals, and evidence of pathway engagement or measurable downstream effects consistent with the proposed mechanism.
What grant mechanism was used?
This opportunity used the NIH R01 grant mechanism.
What was the funding activity area and CFDA listing?
The funding activity area was Health, and the CFDA listing was 93.866 (Aging Research).
How much total funding was NIH expecting to make available?
NIH estimated a total of $4,000,000 in funding available under the announcement.
What was the maximum award amount (award ceiling)?
The maximum award amount (award ceiling) listed was $800,000.
Was cost sharing or matching required?
No. The program did not require cost sharing or matching.
When was the opportunity posted and when did it close?
The announcement was posted on October 15, 2012, created on December 12, 2012, and it closed in January 2013 (original closing date January 13, 2013; current closing date January 14, 2013).
Is this funding opportunity still active?
No. The archive date was February 14, 2013, indicating it is no longer an active solicitation and remains available as a record of the program.
Who was eligible to apply?
Eligibility was broad and included domestic and international entities. Eligible applicants included federal, state, county, city/township, and special district governments; public and state-controlled and private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (with the noted exception category relating to institutions of higher education); for-profit organizations other than small businesses; and small businesses.
Were specific institution types explicitly included?
Yes. The eligible categories explicitly included faith-based and community-based organizations, historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, U.S. territories or possessions, regional organizations, and eligible federal government agencies.
Could non-U.S. (foreign) organizations participate?
Yes. Non-domestic (foreign) organizations and foreign institutions could apply. Non-domestic components of U.S. organizations were eligible, and foreign components were allowed as defined in the NIH Grants Policy Statement.
Where could applicants find the official full announcement?
The opportunity referenced an official NIH guide link to the full announcement: http://grants.nih.gov/grants/guide/rfa files/RFA AG 13 016.html
Who was the contact for technical access problems with the announcement link?
For technical access issues (for example, if the full announcement could not be accessed electronically or if there were problems linking to the notice), the contact listed was the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
What does "first-in-human" mean in the context of this program?
In the context provided, "first-in-human" refers to the earliest stage of clinical development where a therapeutic candidate moves into initial testing in people to generate early clinical evidence about human metabolic and pharmacologic activity, pharmacokinetics (how the body processes the drug), pharmacodynamics (what the drug does to the body), and basic safety/tolerability and dosing parameters.
What was the practical value of the Phase I data this program aimed to generate?
The intent was to produce early human data that could justify and de-risk progression to Phase II studies, where proof-of-concept and preliminary efficacy questions typically become more central.
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