Pathway and Target Identification for Alzhiemers Disease Related Dementias (ADRDs) (U01 Clinical Trial Not Allowed) | PAR 18 661

Opportunity Information: Apply for PAR 18 661

The NIH funding opportunity PAR-18-661, titled "Pathway and Target Identification for Alzhiemers Disease Related Dementias (ADRDs) (U01 Clinical Trial Not Allowed)," is designed to push forward the discovery side of ADRD research by backing large-scale molecular analyses that can reveal new biological pathways and actionable therapeutic targets. The central aim is to support projects that use high-throughput or broad, platform-style approaches to study human-derived materials in order to better understand the underlying pathophysiology of dementias related to Alzheimer disease. In practical terms, this means generating and interpreting molecular data at scale so researchers can connect specific genes, proteins, metabolites, cellular states, or other molecular signatures to disease mechanisms and, ideally, identify points in those mechanisms that could be targeted for intervention.

A key feature of this FOA is the emphasis on analyzing established or well-defined human resources rather than running clinical trials. The opportunity specifically highlights the use of brain tissue, human biofluids (for example, blood-derived products or cerebrospinal fluid), and human induced pluripotent stem cell (iPSC) resources. The focus on these sample types signals that NIH is looking for mechanistic insight rooted in human biology, including molecular profiling that can link disease-relevant changes to specific cell types, brain regions, or circulating biomarkers. Because the mechanism is "Clinical Trial Not Allowed," applicants are expected to propose studies centered on molecular characterization, integrative analyses, and target/pathway nomination rather than interventional testing in people.

The award mechanism is a U01 cooperative agreement, which typically indicates an expectation of substantial programmatic involvement from NIH staff compared with a standard research project grant. In cooperative agreements, NIH often plays an active role in coordinating, guiding, or harmonizing work across projects, especially when the science benefits from shared standards, data comparability, and community-facing resource generation. While the provided text does not spell out specific coordination requirements, the use of a U01 paired with "large scale molecular platform analysis" strongly suggests that deliverables such as well-annotated datasets, standardized methods, and broadly useful outputs are important to the program goals.

On eligibility, the FOA is broadly open across sectors. Eligible applicants include many types of U.S. governmental entities (state, county, city/township, special districts), public and independent school districts, and a wide range of higher education institutions (public/state-controlled and private). It also includes Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments), as well as public housing authorities/Indian housing authorities. Nonprofit organizations are eligible whether or not they have 501(c)(3) status, and both for-profit organizations (other than small businesses) and small businesses are listed as eligible. The announcement also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American Tribal Governments other than federally recognized, and U.S. territories or possessions.

The foreign eligibility language is nuanced. Non-domestic (non-U.S.) entities and non-U.S. foreign institutions are not eligible to apply as the primary applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. In plain terms, a U.S.-based applicant can include certain international elements or collaborations under NIH rules, but a foreign institution generally cannot serve as the applicant of record for this particular opportunity.

Administratively, the opportunity is categorized as discretionary funding and uses the "Health" activity category, with CFDA numbers 93.853 and 93.866. The sponsoring agency is the National Institutes of Health. The record provided lists an original closing date of 2018-04-16 and a creation date of 2018-02-14, which indicates this is a specific published cycle from that period. The excerpt does not provide an award ceiling or expected number of awards, so those details would normally require checking the full FOA text or NIH reporting pages for the exact budget limits, project period expectations, and programmatic priorities.

Overall, this FOA is best understood as a targeted NIH investment in discovery and translation-enabling science for ADRDs: large-scale molecular profiling of human-relevant samples to map disease biology, surface high-confidence pathways involved in dementia processes, and nominate targets that could later be pursued through preclinical development or future clinical testing under separate clinical-trial-allowing mechanisms.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pathway and Target Identification for Alzhiemers Disease Related Dementias (ADRDs) (U01 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 2018-02-14.
• Applicants must submit their applications by 2018-04-16. (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 18 661

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