Neuropathological Interactions Between COVID-19 and ADRD (R01 - Clinical Trial Not Allowed) | PAR 23 214

Frequently Asked Questions (FAQs): Neuropathological Interactions Between COVID-19 and ADRD (PAR-23-214)

1) What is the Neuropathological Interactions Between COVID-19 and ADRD funding opportunity (PAR-23-214)?

PAR-23-214 is a National Institutes of Health (NIH) funding opportunity using the R01 grant mechanism to support mechanistic research on how COVID-19 influences Alzheimer disease (AD) and Alzheimer disease-related dementias (ADRD).

2) What is the main purpose of this grant program?

The purpose is to move beyond broad clinical observations and identify biological mechanisms that explain how SARS-CoV-2 infection, COVID-19-related inflammation, or downstream consequences of infection interact with AD/ADRD-relevant brain changes and cognitive outcomes.

3) What kind of research does this FOA prioritize?

This FOA prioritizes causal, mechanistic studies that test how COVID-19-related biology interacts with established AD/ADRD pathways, risk factors, hallmark pathologies, comorbidities, and relevant readouts tied to dementia vulnerability and cognitive outcomes.

4) Are clinical trials allowed under this opportunity?

No. The work supported is explicitly non-clinical-trial focused. Applicants should propose basic and translational experiments rather than interventional studies in humans.

5) What types of model systems are appropriate for proposed studies?

The announcement emphasizes studies using animal models, cell culture systems, and/or human tissue-based models to test mechanistic interactions between COVID-19 and AD/ADRD biology.

6) What is a key scientific requirement for the models or readouts used in the project?

A key requirement is that the proposed model system or the study readouts must incorporate established AD/ADRD risk factors, hallmark pathologies, or relevant comorbidities. Projects should not study generic viral effects on the nervous system in isolation.

7) What does it mean to connect COVID-19 biology to AD/ADRD-relevant features?

It means proposed experiments should directly relate COVID-19 infection or its consequences to features meaningful for AD/ADRD, such as amyloid or tau-related changes, neuroinflammation, vascular contributions to cognitive impairment, synaptic dysfunction, or other recognized pathways and risk modifiers that influence dementia vulnerability.

8) What are the main mechanistic research directions highlighted by the FOA?

The FOA highlights three broad directions: (1) studying COVID-19 in the context of existing AD/ADRD pathology and how infection modifies CNS pathology and cognitive outcomes; (2) studying prodromal or early-stage scenarios to test whether COVID-19 accelerates disease processes and cognitive deficits; and (3) testing whether COVID-19 increases susceptibility to future AD/ADRD by interacting with known comorbidities or risk factors through plausible cellular and molecular mechanisms.

9) Can a project focus on COVID-19 effects on the nervous system without addressing AD/ADRD factors?

No. The FOA stresses that projects should not examine generic viral or neurological effects in isolation. The work needs to be anchored to AD/ADRD-relevant risk factors, hallmark pathologies, comorbidities, and/or disease-relevant readouts.

10) What is emphasized more: correlation or causation?

Causation. Across the highlighted themes, the emphasis is on causal, mechanistic explanations rather than descriptive correlations.

11) What NIH funding mechanism is used for this opportunity?

This opportunity uses the NIH R01 mechanism, which is typically intended for mature, hypothesis-driven research programs with well-developed aims.

12) What is the award ceiling listed for this opportunity?

The opportunity lists an award ceiling of $500,000.

13) What CFDA numbers are associated with this opportunity?

The opportunity references CFDA numbers 93.853 and 93.866, indicating alignment with NIH research assistance programs that include neuroscience and aging-related portfolios.

14) What was the original closing date listed in the opportunity record?

The original closing date provided is October 4, 2023.

15) When was the opportunity record created?

The opportunity record indicates it was created on June 6, 2023.

16) Who is eligible to apply for this funding opportunity?

Eligibility is broad and includes many U.S.-based organizations such as state, county, city, and special district governments; public and private institutions of higher education; independent school districts; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions where applicable); for-profit organizations (other than small businesses); and small businesses.

17) Are minority-serving institutions and community-based organizations eligible?

Yes. The FOA calls out additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI, Hispanic-serving Institutions, HBCUs, TCCUs, and faith-based or community-based organizations.

18) Are federal agencies eligible to apply?

Yes. Eligible applicants include eligible federal agencies.

19) Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed among eligible applicant categories.

20) Are non-domestic (foreign) organizations eligible to apply?

Yes. Non-domestic entities (foreign organizations) are listed as eligible.

21) Are regional organizations eligible?

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

22) Are tribal governments that are not federally recognized eligible?

Yes. The FOA notes certain tribal governments that are not federally recognized as eligible.

23) What is the overall intent of the eligibility approach in this FOA?

The program is designed to draw applications from a wide range of research environments while keeping the scientific scope tightly focused on mechanistic links between COVID-19 and AD/ADRD-relevant neuropathology and cognitive outcomes.

24) What kinds of outcomes or domains does the FOA repeatedly link to the mechanistic work?

The FOA repeatedly ties the mechanistic questions to central nervous system pathology and cognitive outcomes, with specific attention to AD/ADRD-relevant pathologies and risk modifiers (for example, amyloid/tau-related changes, neuroinflammation, vascular contributions, and synaptic dysfunction).

25) In plain terms, what would make a proposal feel aligned with this FOA?

A proposal would be aligned if it uses animal, cell, or human tissue-based experimental systems to test specific, causal mechanisms by which SARS-CoV-2 infection or COVID-19-related inflammatory/downstream effects interact with AD/ADRD risk factors, hallmark pathology, comorbidities, and disease-relevant readouts tied to brain pathology and cognition, without proposing a clinical trial.