Opportunity Information: Apply for RFA AG 20 017
The Lucidity in Dementia (R21/R33 Clinical Trial Optional) funding opportunity (RFA-AG-20-017) is a National Institutes of Health (NIH) discretionary grant program in the health area (CFDA 93.866) aimed at building a stronger scientific foundation around the phenomenon of lucidity in people living with dementia. The central purpose is to move the field beyond anecdotal reports by supporting an initial wave of research that can define, measure, and better understand episodes of lucidity, including when they occur, what they look like, what factors might be associated with them, and how they can be studied rigorously. The program explicitly invites retrospective studies (using existing records, caregiver accounts, clinical documentation, or previously collected datasets) and prospective studies (following individuals forward in time to capture and characterize lucidity as it happens). The overall intent is to generate data and methods that make future, larger studies possible and more precise.
A key structural feature of this opportunity is the use of the R21/R33 phased innovation mechanism. In practical terms, this means applicants are expected to propose a two-part project. The first phase (R21) supports exploratory and developmental work, such as refining definitions and conceptual models of lucidity, developing or pilot-testing assessment tools and protocols, establishing feasibility of recruitment and data collection approaches, and gathering early evidence to justify expansion. The second phase (R33) is designed for the “next step” after feasibility is shown, allowing investigators to scale up or broaden the work into more robust, expanded aims. This could include larger samples, more intensive or longer follow-up, improved measurement approaches validated in the R21, or multi-site implementation depending on what the early phase demonstrates. The phased design signals that NIH expects innovation and uncertainty early on, paired with a clear plan for how initial findings will transition into a more definitive study if pre-specified milestones are met.
The “Clinical Trial Optional” designation indicates that projects may include clinical trial elements, but they do not have to. In other words, researchers can propose observational work focused on naturalistic episodes of lucidity, measurement development, qualitative or mixed-methods designs, and other non-interventional approaches, or they can propose interventional studies if the research questions and design meet NIH’s definition of a clinical trial. This flexibility is important for a topic like lucidity in dementia, where the field may still be developing shared definitions, reliable detection methods, and ethical and practical approaches for studying the phenomenon in real-world settings.
Eligibility is broad and intentionally inclusive. Standard eligible applicants listed include a wide range of public entities (state, county, city/township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities), higher education institutions (public/state-controlled and private), Native American tribal governments (federally recognized), Native American tribal organizations (other than federally recognized governments), nonprofits both with and without 501(c)(3) status (excluding institutions of higher education as specified), for-profit organizations (other than small businesses), and small businesses. In addition, the announcement highlights “Other Eligible Applicants,” emphasizing participation from diverse and community-connected organizations and institutions. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Indian/Native American Tribal Governments other than federally recognized; eligible federal agencies; faith-based or community-based organizations; regional organizations; U.S. territories or possessions; and non-U.S. entities (foreign organizations). This breadth suggests a strong interest in encouraging varied research perspectives, community partnerships, and studies that can address lucidity in different populations and care contexts.
From an administrative standpoint, the opportunity is offered by NIH, was created on 2019-05-06, and had an original closing date of 2020-02-03. The listing does not specify an award ceiling or expected number of awards in the provided data, so applicants would typically look to the full FOA text or NIH budget guidelines for details on allowable costs, project period expectations, and any institute-specific budget caps. Overall, the program is positioned as a field-building investment: it supports early, methodologically grounded studies that can establish how to identify and examine lucidity in dementia, and then supports a planned expansion phase to deepen the evidence base and set up future research trajectories.Apply for RFA AG 20 017
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Lucidity in Dementia (R21/R33 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
- This funding opportunity was created on 2019-05-06.
- Applicants must submit their applications by 2020-02-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: Lucidity in Dementia (R21/R33 Clinical Trial Optional) - RFA-AG-20-017
What is this funding opportunity?
This is an NIH discretionary grant opportunity titled Lucidity in Dementia (R21/R33 Clinical Trial Optional), funding opportunity number RFA-AG-20-017. It is listed in the health area under CFDA 93.866 and focuses on building scientific knowledge about the phenomenon of lucidity in people living with dementia.
What is the main purpose of the program?
The central purpose is to move research on lucidity in dementia beyond anecdotal reports by supporting an initial wave of studies that can define, measure, and better understand episodes of lucidity. The intent is to produce data and methods that make future, larger studies possible and more precise.
What does NIH mean by “lucidity” in the context of dementia research?
Based on the opportunity description, “lucidity” refers to episodes in people living with dementia that researchers aim to systematically characterize, including when these episodes occur, what they look like, and what factors might be associated with them. The program emphasizes developing shared definitions and rigorous ways to identify and study these episodes.
What kinds of research approaches are encouraged?
The opportunity explicitly invites both:
- Retrospective studies using existing records, caregiver accounts, clinical documentation, or previously collected datasets.
- Prospective studies that follow individuals forward in time to capture and characterize lucidity as it happens.
Are observational studies allowed, or does it need to be an intervention?
Observational studies are allowed. The FOA is labeled Clinical Trial Optional, meaning applicants may propose non-interventional research (such as naturalistic observation, measurement development, qualitative or mixed-methods designs) or propose interventional research if it meets NIH’s definition of a clinical trial.
What does “Clinical Trial Optional” mean here?
It means a project may include clinical trial elements, but it is not required. This allows applicants to choose the design that best fits their questions, whether that is observational work or an intervention that meets NIH’s clinical trial definition.
What is the R21/R33 phased innovation mechanism?
This opportunity uses the R21/R33 phased innovation structure, which is designed as a two-part project:
- R21 phase: exploratory/developmental work to address early uncertainty and innovation needs.
- R33 phase: a planned expansion phase that can begin after feasibility is demonstrated and milestones are met.
What kinds of activities fit in the R21 phase?
The R21 phase is intended for exploratory and developmental work such as refining definitions and conceptual models of lucidity, developing or pilot-testing tools and protocols, establishing feasibility of recruitment and data collection, and generating early evidence that supports moving to a larger or more robust study.
What kinds of activities fit in the R33 phase?
The R33 phase is intended for the “next step” after feasibility is shown. Examples mentioned include scaling up to larger samples, conducting longer or more intensive follow-up, using improved measurement approaches validated during the R21, or implementing work across multiple sites if early findings support it.
Do applicants need a clear plan for transitioning from R21 to R33?
Yes. The phased structure signals that applicants should propose a two-part project and include a clear plan for how early, feasibility-focused work will transition into expanded aims, contingent on meeting pre-specified milestones.
What is NIH hoping to achieve by funding these projects?
NIH describes this as a field-building investment. The goal is to support methodologically grounded studies that establish how to identify and examine lucidity in dementia, creating a stronger foundation for future research and larger studies.
What specific questions about lucidity does the program want researchers to address?
Based on the description, NIH is interested in research that can help determine:
- How to define and measure lucidity in dementia.
- When episodes occur.
- What episodes look like (characteristics and presentation).
- What factors might be associated with lucidity.
- How to study the phenomenon rigorously in real-world or research settings.
What types of data sources are explicitly mentioned for retrospective studies?
The opportunity highlights using existing records, caregiver accounts, clinical documentation, and previously collected datasets to study lucidity retrospectively.
What does NIH mean by prospective studies in this context?
Prospective studies are described as those that follow individuals forward in time to capture and characterize lucidity episodes as they happen, rather than relying only on past records.
Who is eligible to apply?
Eligibility is broad. The standard eligible applicants listed include:
- State governments; county governments; city/township governments
- Special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Public/state-controlled and private institutions of higher education
- Native American tribal governments (federally recognized)
- Native American tribal organizations (other than federally recognized governments)
- Nonprofits with and without 501(c)(3) status (excluding institutions of higher education as specified)
- For-profit organizations (other than small businesses)
- Small businesses
What “other eligible applicants” are specifically highlighted?
The announcement emphasizes additional eligible applicants to encourage diverse and community-connected participation, including:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISI)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Indian/Native American Tribal Governments other than federally recognized
- Eligible federal agencies
- Faith-based or community-based organizations
- Regional organizations
- U.S. territories or possessions
- Non-U.S. entities (foreign organizations)
Are non-U.S. (foreign) organizations allowed to apply?
Yes. The eligibility section explicitly includes non-U.S. entities (foreign organizations) among the “Other Eligible Applicants.”
Are faith-based or community-based organizations eligible?
Yes. The opportunity explicitly lists faith-based or community-based organizations among “Other Eligible Applicants.”
Does the listing provide an award ceiling or expected number of awards?
No. The provided information states that the listing does not specify an award ceiling or expected number of awards. Applicants would typically need to consult the full FOA text or NIH budget guidelines for those details.
When was this opportunity created and when did it close?
The opportunity was created on 2019-05-06, and the original closing date listed is 2020-02-03.
What makes this opportunity “field-building”?
It is positioned as field-building because it supports early, foundational work (definitions, measures, feasibility, and initial datasets) and then supports a planned expansion phase. The aim is to establish methods and evidence that enable stronger, more precise future studies on lucidity in dementia.
Does the program require either retrospective or prospective design, or can applicants choose?
Applicants can choose. The program explicitly invites both retrospective and prospective approaches, reflecting flexibility in how researchers can rigorously study lucidity.
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