Opportunity Information: Apply for PAR 08 062

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Alzheimer s Disease Pilot Clinical Trials (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213 Research and Training in Complementary and Integrative Health 93.361 Nursing Research 93.866 Aging Research.
  • This funding opportunity was created on Dec 5, 2008 and posted on Dec 27, 2007.
  • Applicants must submit their applications by Jan 7, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Public housing authorities/Indian housing authorities For profit organizations other than small businesses State governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Private institutions of higher education Native American tribal governments (Federally recognized) Independent school districts Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
  • Foreign institutions are eligible to apply. Eligible agencies of the Federal Government can apply. Faith based or community based organizations can apply.
Apply for PAR 08 062

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Opportunity Summary:

The Alzheimer s Disease Pilot Clinical Trials (R01) funding opportunity (PAR 08 062) is an NIH research grant program designed to speed up early stage clinical testing of promising approaches for Alzheimer s disease and related cognitive disorders. It sits within the broader Alzheimer s Disease Prevention Initiative that began in 1999 at the direction of Congress, led by the National Institute on Aging (NIA) in collaboration with other NIH partners. The main motivation behind the initiative, and this announcement specifically, is to close the gap between basic science discoveries and real world clinical evaluation by supporting pilot trials that can generate the practical, human evidence needed to decide what should move forward into larger, definitive studies.

This FOA is focused specifically on pilot clinical trials rather than drug discovery or preclinical development. In other words, the goal is not to fund the earliest laboratory work to identify new compounds, but to support small, well designed clinical studies that test whether an intervention looks feasible, safe, and potentially effective in people. The clinical emphasis is on interventions intended to prevent or treat cognitive and behavioral symptoms associated with mild cognitive impairment (MCI), Alzheimer s disease (AD), and age related cognitive decline. The announcement makes room for both pharmacologic approaches (for example, drug based strategies) and behavioral interventions (for example, structured programs that aim to change behavior, improve coping, support cognition, or address symptoms through non drug methods). Because the National Center for Complementary and Alternative Medicine (NCCAM, now known as NCCIH in later NIH naming) is included as a participating organization alongside NIA and the National Institute of Nursing Research (NINR), the scope also clearly welcomes research that fits within complementary, integrative, and nursing relevant approaches, so long as the work is conducted as a rigorous pilot clinical trial and targets the appropriate patient populations and outcomes.

The grant mechanism is the NIH R01, which typically supports investigator initiated research projects and can cover a wide range of clinical trial designs appropriate for pilot work. The key idea behind a pilot clinical trial is that it helps the field make smarter decisions faster: it can test recruitment strategies, adherence, tolerability, dosing or intervention intensity, outcome measures, and early signals of benefit. In the Alzheimer s space, where large trials are expensive and time consuming, this type of funding is meant to reduce risk before committing to major multisite efforts. This FOA was also positioned as one piece of a broader set of NIH Alzheimer s related announcements, with other FOAs aimed at drug discovery and development; applicants were expected to align their project with the pilot clinical trial purpose of this particular program.

Administratively, this is a discretionary grant opportunity offered by the National Institutes of Health. The program was posted on Dec 27, 2007, and the closing date listed is Jan 7, 2011, with an archive date of Feb 7, 2011, meaning it is no longer active as a current competition but remains part of the historical NIH funding record. There is no cost sharing or matching requirement, consistent with many NIH research grants.

Eligibility is broad and includes many types of US organizations and institutions such as public and private institutions of higher education, nonprofits with or without 501(c)(3) status, for profit organizations other than small businesses, small businesses, state and local governments, independent school districts, special district governments, and various tribal organizations including federally recognized tribal governments. The announcement also states that foreign institutions are eligible to apply, eligible federal agencies may apply, and faith based or community based organizations may apply, which further expands who can serve as an applicant organization as long as they can meet NIH grant requirements and conduct the proposed clinical research responsibly.

The opportunity is associated with multiple CFDA numbers reflecting the participating NIH institutes and the scientific areas involved, including aging research, nursing research, and complementary and integrative health research. The official full announcement was available via the NIH grants guide page listed in the additional information link, and the NIH Office of Extramural Research provided a webmaster contact for access or technical issues with the posting.

FAQs: Alzheimer's Disease Pilot Clinical Trials (R01) - PAR-08-062

What is PAR-08-062?

PAR-08-062 is an NIH funding opportunity titled "Alzheimer's Disease Pilot Clinical Trials (R01)." It is a research grant program intended to speed up early-stage clinical testing of promising approaches for Alzheimer's disease and related cognitive disorders by supporting pilot clinical trials in people.

What is the main purpose of this funding opportunity?

The purpose is to close the gap between basic science discoveries and real-world clinical evaluation by funding small, well-designed pilot trials that generate practical human evidence to inform whether an intervention should move forward into larger, definitive studies.

What kind of studies does this FOA support?

This FOA supports pilot clinical trials. These are smaller clinical studies designed to evaluate feasibility, safety, and early signals of potential effectiveness in humans, and to refine key trial elements before larger trials are launched.

Does this FOA fund drug discovery or preclinical research?

No. The focus is not on the earliest laboratory work such as identifying new compounds or conducting preclinical development. It is specifically aimed at clinical testing in people through pilot trials.

What diseases or conditions are within scope?

The FOA targets interventions intended to prevent or treat cognitive and behavioral symptoms associated with mild cognitive impairment (MCI), Alzheimer's disease (AD), and age-related cognitive decline.

What types of interventions are eligible?

Both pharmacologic approaches (drug-based strategies) and behavioral interventions (structured non-drug programs) are within scope, as long as they are tested through a rigorous pilot clinical trial and focus on the appropriate populations and outcomes.

Are complementary or integrative health approaches allowed?

Yes. The inclusion of the National Center for Complementary and Alternative Medicine (NCCAM, later known as NCCIH) as a participating organization indicates that complementary and integrative approaches are welcomed if they are studied as rigorous pilot clinical trials and address the targeted cognitive/behavioral symptoms and populations.

Is nursing-related clinical research relevant to this FOA?

Yes. The National Institute of Nursing Research (NINR) is listed as a participating organization, which signals that nursing-relevant approaches are appropriate when framed as pilot clinical trials for the covered conditions and outcomes.

What grant mechanism is used?

The mechanism is the NIH R01, which generally supports investigator-initiated research projects and can accommodate a range of clinical trial designs suitable for pilot work.

What is the value of a pilot clinical trial in Alzheimer's research?

Pilot trials can reduce risk and improve decision-making before committing to expensive, time-consuming large trials. They can help test and refine recruitment approaches, adherence, tolerability, dosing or intervention intensity, outcome measures, and early signals of benefit.

Is this funding opportunity part of a larger NIH initiative?

Yes. It sits within the broader Alzheimer's Disease Prevention Initiative, which began in 1999 at the direction of Congress and is led by the National Institute on Aging (NIA) in collaboration with other NIH partners.

Which NIH organizations are involved?

The National Institute on Aging (NIA) is the lead, with participation from other NIH partners including NCCAM (now NCCIH under later NIH naming) and the National Institute of Nursing Research (NINR).

Is this an active grant opportunity right now?

No. The opportunity is historical/archived. It was posted on December 27, 2007, lists a closing date of January 7, 2011, and an archive date of February 7, 2011.

Does the FOA require cost sharing or matching funds?

No. The information provided states there is no cost sharing or matching requirement, which is consistent with many NIH research grants.

Who is eligible to apply?

Eligibility is broad and includes many types of US organizations and institutions, including public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, state and local governments, independent school districts, special district governments, and tribal organizations including federally recognized tribal governments.

Are foreign institutions eligible?

Yes. The announcement states that foreign institutions are eligible to apply.

Can federal agencies apply?

Yes. The announcement indicates eligible federal agencies may apply.

Are faith-based or community-based organizations eligible?

Yes. The announcement explicitly states that faith-based or community-based organizations may apply, as long as they can meet NIH grant requirements and conduct the proposed clinical research responsibly.

What does it mean that this is a discretionary grant opportunity?

The FOA is described as a discretionary grant opportunity offered by the NIH, meaning it is a program NIH offers under its authorities for extramural research support rather than a formula-based entitlement program.

Are there related NIH announcements that focus on other stages of research?

Yes. This FOA is described as one piece of a broader set of NIH Alzheimer's-related announcements, with other FOAs aimed at drug discovery and development. Applicants were expected to align with the pilot clinical trial purpose of this particular program.

What administrative identifiers are associated with the opportunity?

The opportunity is identified as PAR-08-062 and is associated with multiple CFDA numbers reflecting participating NIH institutes and the relevant scientific areas (including aging research, nursing research, and complementary/integrative health research).

Where was the official full announcement posted?

The full announcement was available via the NIH Grants Guide page referenced in the additional information link described in the provided details.

Who is listed for technical or access issues related to the posting?

The NIH Office of Extramural Research provided a webmaster contact for access or technical issues with the posting.

Browse more opportunities from the same agency: National Institutes of Health

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Funding Number: PA 08 127
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Funding Number: PA 08 128
Agency: National Institutes of Health
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Funding Number: PA 08 129
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Funding Number: PAR 08 135
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