Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01 Clinical Trial Not Allowed) | PAR 19 170

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.

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