Role of Adaptive Immunity in Etiology of Alzheimers Disease and Alzheimers Disease-Related Dementias (R01 Clinical Trial Optional) | RFA AG 22 017

FAQs: NIH RFA-AG-22-017 (R01 Clinical Trial Optional)

What is the funding opportunity called and what is the funding opportunity number?

The opportunity is titled "Role of Adaptive Immunity in Etiology of Alzheimers Disease and Alzheimers Disease-Related Dementias (R01 Clinical Trial Optional)" and the Funding Opportunity Number (FON) is RFA-AG-22-017.

Which agency is sponsoring this opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What type of funding mechanism does this opportunity use?

This opportunity uses the NIH R01 research project grant mechanism.

Is this a grant program or a contract program?

This is a grant program (a discretionary grant program, as described in the provided information).

What research area or activity category does this opportunity fall under?

The activity category is health research.

What is the core purpose of RFA-AG-22-017?

The core purpose is to move beyond broad concepts of inflammation and clarify how the adaptive immune system contributes to Alzheimers disease and Alzheimers disease-related dementias (AD/ADRD). The FOA is focused on understanding whether adaptive immune components (including T cells, B cells, and antigen-specific immune responses) influence disease initiation, acceleration, or protection across the AD/ADRD spectrum.

What does the FOA mean by "adaptive immunity" in this context?

Based on the provided description, adaptive immunity refers to components such as T cells, B cells, and antigen-specific immune responses that may shape AD/ADRD biology (potentially driving harm, providing protection, or doing both depending on timing, cell type, and disease stage).

Does the opportunity require a clinical trial?

No. The FOA is "Clinical Trial Optional," meaning applicants may propose either non-clinical mechanistic research or human studies that include interventional designs if justified, but a clinical trial is not required.

Are basic science projects allowed, or is the FOA limited to translational work?

Both basic and translational work are within scope, as stated in the provided information.

What are the main scientific interest areas highlighted by the FOA?

The FOA highlights three main interest areas: (1) brain immune surveillance, (2) generation of CNS-directed immune responses in neurodegenerative disorders, and (3) the functional role of adaptive immunity in AD/ADRD onset and progression.

What does "brain immune surveillance" refer to in this FOA?

In this FOA, brain immune surveillance includes understanding how adaptive immune cells and immune signals interact with the central nervous system under normal conditions, and how that surveillance changes with aging and neurodegeneration.

What does "generation of CNS-directed immune responses" mean here?

This area points to questions such as which antigens may be recognized, how peripheral immune activation may translate to CNS effects, and what pathways permit or restrict immune cell trafficking or antibody access to brain-relevant compartments.

What kinds of outcomes or endpoints is the FOA interested in connecting to adaptive immune activity?

The FOA is interested in studies that connect immune activity to meaningful disease outcomes, including amyloid or tau pathology, neurodegeneration, synaptic dysfunction, cognition, clinical progression, or resilience.

Is the FOA looking for causality and mechanism or primarily descriptive associations?

The stated intent is to produce clearer causal and mechanistic insight into whether adaptive immune processes drive harm, provide protection, or do both depending on timing, cell type, and disease stage.

Does the FOA focus only on harmful immune effects in AD/ADRD?

No. The FOA explicitly frames adaptive immune processes as potentially harmful, protective, or both, depending on factors like timing, cell type, and disease stage.

What disease areas are included under AD/ADRD for this opportunity?

The FOA targets Alzheimers disease and Alzheimers disease-related dementias (AD/ADRD), as described in the provided information.

What are the CFDA numbers associated with this NIH opportunity?

The associated NIH CFDA numbers listed are 93.853 and 93.866.

When was this funding opportunity created?

The opportunity was created on 2021-06-16.

What is the original closing date listed for this opportunity?

The original closing date listed is 2021-10-28.

Is an award ceiling provided in the information given?

No. An award ceiling is not specified in the provided source.

Does the provided information list the expected number of awards?

No. The expected number of awards is not listed in the provided information.

What should applicants do since the award ceiling and expected number of awards are not provided here?

The provided information indicates applicants should consult the full FOA for budgeting expectations, institute-specific policies, and any constraints tied to scope, duration, or total costs.

Who is eligible to apply (in general terms)?

Eligibility is broad and includes many types of domestic applicants (government entities, higher education institutions, nonprofits, for-profits, and small businesses), and it also includes U.S. territories or possessions and non-U.S. entities (foreign organizations), along with additional categories such as minority-serving and community-oriented institutions.

Which U.S. government entities are eligible?

Eligible domestic government applicants include state governments; county governments; city or township governments; special district governments; independent school districts; and eligible federal agencies.

Are institutions of higher education eligible?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are eligible.

Are nonprofit organizations eligible?

Yes. Nonprofit organizations with or without 501(c)(3) status are eligible (excluding institutions of higher education in those nonprofit categories, as stated in the provided information).

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) and small businesses are both listed as eligible.

Are tribal entities eligible to apply?

Yes. Federally recognized Native American tribal governments and tribal organizations other than federally recognized governments are listed as eligible.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are listed as eligible.

Are minority-serving institutions specifically mentioned as eligible?

Yes. The FOA explicitly mentions eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly listed among eligible applicant types.

Are regional organizations eligible?

Yes. Regional organizations are included in the eligible applicant types listed.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are explicitly listed as eligible.

Are foreign organizations eligible to apply?

Yes. Non-U.S. entities (foreign organizations) are explicitly listed as eligible.

What is the overarching scientific emphasis of this FOA?

The FOA emphasizes deeper mechanistic understanding of adaptive immunity in AD/ADRD, with specific attention to immune surveillance of the brain, CNS-directed immune responses, and how adaptive immune function relates to disease timing and trajectory (initiation, progression, and resilience).

Does the FOA encourage research spanning different stages of disease?

Yes. The provided information describes interest in effects across the AD/ADRD spectrum and notes that immune effects may vary by timing and disease stage.