Opportunity Information: Apply for PAR 19 170

Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number PAR-19-170) that supports research aimed at clarifying why some people with Parkinson's disease dementia (PDD) experience faster or more severe cognitive decline than others. The central focus is on identifying risk factors and progression markers for dementia in PDD, with the practical goal of improving prediction of who will develop cognitive impairment and/or progress to dementia and understanding the biological and clinical features that track with that worsening over time. The award mechanism is an R01 research project grant, and the announcement explicitly indicates that clinical trials are not allowed under this opportunity, meaning the supported work should be observational and/or based on analysis of clinical data and biospecimens rather than testing an intervention.

A key requirement is that applicants must already have access to well-characterized groups of PDD patients who have been followed longitudinally. In other words, NIH is looking for projects that can build on existing cohorts with established clinical histories, not brand-new recruitment efforts starting from zero. The expectation is that investigators will be able to continue following these participants over time using standardized clinical assessments and collection of biospecimens, and that the follow-up extends through autopsy. That last point signals strong emphasis on linking what is seen during life (cognitive testing results, symptoms, trajectories, biomarkers) with what is found in the brain and other tissues after death, allowing more definitive connections between clinical progression and underlying pathology.

The research supported under this FOA should propose to identify clinical, pathological, and/or biospecimen factors that predict cognitive impairment and dementia outcomes in PDD. Clinical factors could include features such as baseline cognitive profile, motor symptom characteristics, neuropsychiatric symptoms, sleep disturbances, autonomic dysfunction, medication exposure patterns, comorbidities, or other longitudinally measured clinical variables. Pathological factors refer to findings at autopsy that may explain differences in cognitive decline, including the type, severity, and distribution of disease-related changes and co-pathologies. Biospecimen factors broadly include biomarkers measurable in samples collected during life, such as blood, cerebrospinal fluid, or other biological materials, as well as derived measures like molecular signatures, protein markers, genetic risk variants, or other laboratory-based indicators that might correlate with progression. The unifying theme is prediction and tracking: discovering which measures, alone or in combination, can reliably forecast progression and separate faster-progressing from slower-progressing patients.

Because this is categorized under NIH health research and tied to CFDA numbers 93.853 and 93.866, the scope sits within NIH's broader neuroscience and aging-related research portfolios. The opportunity is intended for a wide range of applicant organizations. Eligible applicants include many types of U.S. governmental entities (state, county, city/township, special districts), independent school districts, and public housing authorities/Indian housing authorities, along with public and state-controlled institutions of higher education and private institutions of higher education. Nonprofit organizations are eligible whether or not they have 501(c)(3) status, as are for-profit organizations (other than small businesses) and small businesses. Eligibility also explicitly extends to federally recognized Native American tribal governments and tribal organizations that are not federally recognized tribal governments. In addition, the FOA highlights a broad set of other eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility aligns with NIH's interest in leveraging existing cohorts wherever they exist, including specialized clinical centers and population resources outside the United States, as long as the applicant can meet the scientific and operational requirements.

From an administrative standpoint, the opportunity was created on 2019-01-24 and listed an original closing date of 2019-05-07. The funding instrument is a grant, and the activity category is health. While the source excerpt does not specify an award ceiling or expected number of awards, the substance of the announcement makes clear that NIH is prioritizing rigorous longitudinal research designs with continued follow-up, consistent clinical phenotyping, systematic biospecimen collection, and eventual neuropathological confirmation at autopsy. Overall, the FOA is built to accelerate discovery of progression markers that can improve prognosis, patient stratification for future studies, and mechanistic understanding of cognitive decline in Parkinson's disease dementia, without conducting interventional clinical trials within the funded project.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
  • This funding opportunity was created on 2019-01-24.
  • Applicants must submit their applications by 2019-05-07. (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.
Apply for PAR 19 170

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Frequently Asked Questions (FAQs)

What is the name of this grant opportunity?

The opportunity is titled "Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01 Clinical Trial Not Allowed)".

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is PAR-19-170.

Which federal agency is offering this funding opportunity?

This is a National Institutes of Health (NIH) discretionary grant opportunity.

What is the main purpose of this FOA?

The FOA supports research aimed at clarifying why some people with Parkinson's disease dementia (PDD) experience faster or more severe cognitive decline than others. The practical goal is to improve prediction of who will develop cognitive impairment and/or progress to dementia and to understand the biological and clinical features that track with worsening over time.

What type of grant mechanism does this opportunity use?

The award mechanism is an R01 research project grant.

Are clinical trials allowed under this FOA?

No. The announcement explicitly states under this opportunity. Supported work should be observational and/or based on analysis of clinical data and biospecimens rather than testing an intervention.

If clinical trials are not allowed, what kind of research is expected?

The FOA emphasizes observational and longitudinal research approaches, including continued follow-up of existing participants using standardized clinical assessments, systematic biospecimen collection, and analysis of clinical data and biospecimens. It also stresses linking findings during life with neuropathology at autopsy.

What is the central scientific focus of the projects NIH is seeking?

The central focus is identifying risk factors and progression markers for dementia in PDD, including measures that help predict and track cognitive decline over time and separate faster-progressing patients from slower-progressing patients.

What does NIH mean by "progression markers" in this context?

Based on the description provided, progression markers are clinical, pathological, and/or biospecimen factors that track with cognitive decline over time in PDD and help predict who will worsen more quickly or severely.

What is a key eligibility or readiness requirement for applicants (beyond organizational eligibility)?

A key requirement is that applicants must already have access to well-characterized groups of PDD patients who have been followed longitudinally. NIH is looking for projects that can build on existing cohorts with established clinical histories, not brand-new recruitment efforts starting from zero.

Does the FOA expect projects to recruit entirely new cohorts?

No. The FOA indicates NIH is prioritizing studies that build on existing longitudinal cohorts rather than starting new recruitment from scratch.

What does the FOA expect regarding follow-up duration and endpoints?

The expectation is that investigators will continue following participants over time with standardized assessments and biospecimen collection, and that follow-up extends through autopsy, allowing clinical progression to be linked to neuropathological findings.

Why is autopsy follow-up emphasized?

The FOA highlights autopsy follow-up to enable stronger linkage between what is observed during life (for example, cognitive trajectories and biomarkers) and what is found in brain and other tissues after death, helping make more definitive connections between clinical progression and underlying pathology.

What kinds of clinical factors might be studied as predictors of cognitive decline in PDD?

The FOA describes clinical factors that could include: baseline cognitive profile, motor symptom characteristics, neuropsychiatric symptoms, sleep disturbances, autonomic dysfunction, medication exposure patterns, comorbidities, and other longitudinally measured clinical variables.

What kinds of pathological factors are within scope?

Pathological factors refer to findings at autopsy that may explain differences in cognitive decline, including the type, severity, and distribution of disease-related changes and co-pathologies.

What kinds of biospecimen factors or biomarkers are within scope?

The FOA includes biomarkers measurable in samples collected during life, such as blood, cerebrospinal fluid, or other biological materials, as well as derived measures like molecular signatures, protein markers, genetic risk variants, or other laboratory-based indicators that might correlate with progression.

Is the FOA focused more on prediction, tracking over time, or both?

Both. The unifying theme is prediction and tracking: identifying measures that can forecast progression and distinguish faster-progressing from slower-progressing patients.

What is the overall activity category and funding instrument?

The activity category is health, and the funding instrument is a grant.

Which CFDA numbers are associated with this opportunity?

The FOA is tied to CFDA numbers 93.853 and 93.866.

When was this opportunity created?

The opportunity was created on 2019-01-24.

What was the original closing date listed for this opportunity?

The original closing date listed is 2019-05-07.

Who can apply (in general terms)?

The FOA allows a wide range of applicant organizations, including U.S. governmental entities, higher education institutions (public and private), nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, tribal governments and tribal organizations (including certain non-federally recognized tribal organizations), eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations).

Are foreign (non-U.S.) organizations eligible to apply?

Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).

Are small businesses eligible to apply?

Yes. Small businesses are listed among eligible applicants.

Are for-profit organizations eligible to apply?

Yes. For-profit organizations (other than small businesses) are explicitly listed as eligible, and small businesses are also listed separately as eligible.

Are nonprofits required to have 501(c)(3) status to be eligible?

No. The FOA states that nonprofit organizations are eligible whether or not they have 501(c)(3) status.

Are institutions that serve specific populations (such as HBCUs or Hispanic-serving institutions) eligible?

Yes. The eligibility list explicitly includes HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and AANAPISISs, among others.

Does the excerpt specify an award ceiling or the expected number of awards?

No. The provided information states that the excerpt does not specify an award ceiling or the expected number of awards.

What is the practical impact NIH is aiming for with this research?

The FOA is designed to accelerate discovery of progression markers that can improve prognosis, help stratify patients for future studies, and deepen mechanistic understanding of cognitive decline in Parkinson's disease dementia, without conducting interventional clinical trials within the funded project.

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