Opportunity Information: Apply for PAS 19 210
This funding opportunity, PAS 19-210, is an NIH discretionary grant using the R01 mechanism and is explicitly labeled "Clinical Trial Not Allowed." The scientific goal is to improve understanding of why some people with Parkinson's disease dementia (PDD) experience faster or more severe cognitive decline than others by identifying markers and risk factors that predict progression. In practical terms, the program is looking for studies that can pinpoint progression markers for cognitive impairment and dementia in PDD using information that may come from clinical features, pathology, and biological samples.
A central requirement is that applicants already have access to well-characterized cohorts of individuals with PDD who have been followed over time, and that these participants can continue to be followed longitudinally. The expectation is ongoing, structured clinical assessments combined with biospecimen collection, with follow-up extending through autopsy. This makes the opportunity especially focused on research teams connected to established longitudinal studies, clinical centers, registries, or brain donation programs where consent, retention strategies, specimen workflows, and neuropathology pipelines are already in place or can be reliably sustained. The intended payoff is a clearer ability to forecast which patients are most likely to develop worsening cognitive impairment and/or dementia, based on measurable indicators collected during life and confirmed with postmortem findings.
The types of predictors the FOA encourages include clinical factors (for example, patterns of cognitive testing results, neuropsychiatric symptoms, motor features, sleep or autonomic symptoms, medication exposures, comorbidities, functional measures, or other systematically captured clinical trajectories), pathological factors (neuropathologic findings at autopsy, potentially including the burden or distribution of relevant proteinopathies and other neurodegenerative changes), and biospecimen-based factors (such as blood, cerebrospinal fluid, genetic data, and other biomarkers derived from collected samples). The emphasis is on factors that can meaningfully predict progression, not just correlate with diagnosis at one point in time, which is why the longitudinal design and autopsy confirmation are highlighted so strongly.
Because it is an R01, the opportunity is geared toward well-developed projects with strong preliminary rationale and a clear analytic plan that leverages existing longitudinal resources. The "clinical trial not allowed" designation means the funded work should not be designed as an interventional study that prospectively assigns participants to an intervention to evaluate health outcomes. Instead, the work fits observational, natural-history, or biomarker and pathology-correlation designs, including prospective follow-up of an existing cohort, provided it does not cross into testing an intervention as a clinical trial.
Eligibility is broad and includes a wide range of domestic applicant types: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities. The announcement also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). The funding activity category is health, and the CFDA numbers associated with the announcement are 93.853 and 93.866. The opportunity was created on March 5, 2019, and the original closing date listed is November 5, 2019.Apply for PAS 19 210
- 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 2019-03-05.
- Applicants must submit their applications by 2019-11-05. (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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Frequently Asked Questions (FAQs) - NIH PAS 19-210 (R01)
What is the funding opportunity number and what agency is offering it?
The opportunity is PAS 19-210. It is a National Institutes of Health (NIH) discretionary grant.
What grant mechanism is used for this opportunity?
This opportunity uses the R01 mechanism, which is generally intended for well-developed research projects with a strong rationale and a clear analytic plan.
Are clinical trials allowed under this announcement?
No. The announcement is explicitly labeled "Clinical Trial Not Allowed," meaning the proposed research should not be an interventional study that prospectively assigns participants to an intervention to evaluate health outcomes.
What is the main scientific goal of PAS 19-210?
The goal is to improve understanding of why some people with Parkinson's disease dementia (PDD) experience faster or more severe cognitive decline than others, by identifying markers and risk factors that predict progression.
What kinds of studies is the program looking for?
The program is looking for studies that can identify progression markers for cognitive impairment and dementia in PDD using information from clinical features, pathology, and biological samples, with a strong emphasis on longitudinal follow-up and autopsy confirmation.
Why is longitudinal follow-up emphasized so strongly?
The focus is on predictors of progression (who gets worse, how quickly, and in what ways), not just factors that correlate with diagnosis at a single time point. Longitudinal assessments help capture change over time, which is central to predicting progression.
Is access to an existing cohort required?
Yes. A central requirement is that applicants already have access to well-characterized cohorts of individuals with PDD who have been followed over time, and that these participants can continue to be followed longitudinally.
What level of cohort characterization is expected?
The cohort should be well-characterized and already followed over time. The expectation includes ongoing, structured clinical assessments combined with biospecimen collection, with follow-up extending through autopsy.
Does the FOA expect biospecimen collection as part of the project?
Yes. The opportunity highlights biospecimen collection as part of the ongoing longitudinal follow-up, supporting biomarker and pathology-correlation analyses.
Is autopsy follow-up part of the expectation?
Yes. The FOA emphasizes follow-up extending through autopsy and highlights the value of confirming measurable indicators collected during life with postmortem findings.
What kinds of clinical predictors are encouraged?
Examples of clinical predictors encouraged include patterns of cognitive testing results, neuropsychiatric symptoms, motor features, sleep or autonomic symptoms, medication exposures, comorbidities, functional measures, and other systematically captured clinical trajectories.
What kinds of pathological predictors are encouraged?
The FOA encourages pathological factors based on neuropathologic findings at autopsy, including the burden or distribution of relevant proteinopathies and other neurodegenerative changes.
What kinds of biospecimen-based predictors are encouraged?
Examples include biomarkers derived from blood and cerebrospinal fluid, genetic data, and other biomarkers generated from collected biological samples.
Does the FOA prioritize predictors of progression versus cross-sectional correlates?
Yes. The emphasis is on factors that meaningfully predict progression over time, not just factors that correlate with diagnosis at one point in time.
What types of research designs are a good fit given the "Clinical Trial Not Allowed" designation?
Observational, natural-history, and biomarker and pathology-correlation designs are a good fit. Prospective follow-up of an existing cohort is appropriate as long as the study does not prospectively assign participants to an intervention to evaluate health outcomes.
Can a project include prospective follow-up?
Yes. Prospective follow-up of an existing cohort is consistent with the FOA's longitudinal focus, provided the work remains non-interventional and does not become a clinical trial.
Who is this opportunity especially suited for?
It is especially suited for research teams connected to established longitudinal studies, clinical centers, registries, or brain donation programs where consent, retention strategies, specimen workflows, and neuropathology pipelines are already in place or can be reliably sustained.
What is the intended payoff or outcome of funded research?
The intended payoff is improved ability to forecast which patients are most likely to develop worsening cognitive impairment and/or dementia in PDD based on measurable indicators collected during life and confirmed with postmortem findings.
What is the funding activity category for this opportunity?
The funding activity category is health.
What CFDA numbers are associated with this announcement?
The CFDA numbers associated with the announcement are 93.853 and 93.866.
When was this opportunity created?
The opportunity was created on March 5, 2019.
What is the original closing date listed for this opportunity?
The original closing date listed is November 5, 2019.
What types of organizations are eligible to apply?
Eligibility is broad. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities.
Are foreign (non-U.S.) organizations eligible?
Yes. The announcement explicitly includes non-domestic (non-U.S.) entities (foreign organizations) among eligible applicant types.
Are minority-serving and special types of institutions specifically called out as eligible?
Yes. The announcement explicitly calls out eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
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Previous opportunity: FY2019 Office of Naval Research Historically Black Colleges and Universities/Minority Institutions (HBCU/MI) Program
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