Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01 Clinical Trial Not Allowed) | PAS 19 210

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.

• 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.

Apply for PAS 19 210

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