Exosomes: From Biogenesis and Secretion to the Early Pathogenesis of Alzheimer's Disease (R01 - Clinical Trial Not Allowed) | RFA AG 18 027

Opportunity Information: Apply for RFA AG 18 027

The grant opportunity titled "Exosomes: From Biogenesis and Secretion to the Early Pathogenesis of Alzheimer's Disease (R01 - Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AG-18-027) is a National Institutes of Health (NIH) research funding announcement that supports hypothesis-driven, mechanistic work on how exosomes are formed, loaded with cargo, and released, and how those processes may shape the earliest stages of Alzheimer's disease. The central scientific emphasis is on sporadic and late-onset Alzheimer's disease, with a clear focus on the "early pathogenesis" window, meaning the biological changes that occur before or at the very beginning of overt clinical symptoms. The FOA is positioned around the idea that exosomes, as small extracellular vesicles involved in intercellular communication, may influence how disease-relevant molecules move between cells and how pathology starts or spreads in the brain.

Scientifically, the announcement calls for innovative research that connects exosome biogenesis and secretion to Alzheimer's disease mechanisms. It specifically encourages projects that identify, dissect, and characterize the regulation of the molecular machinery responsible for exosome formation and the secretion of exosomal cargo molecules in Alzheimer's disease contexts. In practical terms, this points investigators toward studying the pathways and protein complexes that control vesicle generation and trafficking, the rules that govern cargo selection (for example, which proteins, lipids, and nucleic acids get packaged), and how these processes change under disease-relevant conditions. The FOA also highlights "collaborative approaches," signaling that applications that bring together complementary expertise (such as neurodegeneration biology, vesicle biology, proteomics, genomics, advanced imaging, bioinformatics, or model system development) are especially aligned with the program's intent.

From an administrative and funding standpoint, this is an R01 research project grant mechanism under the NIH, categorized as discretionary funding and aligned with a health-focused activity category (CFDA 93.866). The clinical trial designation is "Clinical Trial Not Allowed," which means the supported work must not include prospective assignment of human participants to interventions to study health-related outcomes. Applicants can still typically incorporate human-derived biospecimens, observational studies, or analyses of existing datasets if those activities do not meet the NIH definition of a clinical trial, but the FOA's structure makes it clear the core expectation is preclinical and/or mechanistic research rather than interventional testing in humans.

The opportunity is broadly open to a wide range of applicant organizations. Eligible applicants include multiple levels of government entities (state, county, city or township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, and a variety of nonprofit organizations (including both 501(c)(3) and non-501(c)(3) nonprofits, excluding institutions of higher education in those nonprofit categories). It also allows for-profit organizations (other than small businesses) and small businesses, as well as Native American tribal governments that are federally recognized and Native American tribal organizations that are not federally recognized tribal governments. In addition, the FOA explicitly calls out a number of other eligible applicant types, including 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, US territories or possessions, and even non-domestic (non-US) entities (foreign organizations). That breadth signals an intent to encourage participation across many institutional settings and geographies, including institutions serving historically underrepresented communities and international collaborators or applicants.

Key dates and budget parameters provided in the source data include an original closing date of March 26, 2018, and a listed award ceiling of $500,000. The record shows a creation date of December 14, 2017. The expected number of awards is not specified in the provided excerpt, which typically means the number may have depended on available institute funds and the quality of the submitted applications in that cycle.

Overall, this FOA is best understood as a targeted NIH push to clarify whether, how, and through which regulated cellular machines exosomes contribute to the initiation and early propagation of Alzheimer's-related pathology in sporadic and late-onset disease. It is designed for teams that can move beyond descriptive associations and instead deliver mechanistic insight into exosome production, cargo loading, and secretion, and how those processes may drive or modulate early disease biology, while staying clearly outside the scope of NIH-defined clinical trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exosomes: From Biogenesis and Secretion to the Early Pathogenesis of Alzheimer's Disease (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): 93.866.
• This funding opportunity was created on 2017-12-14.
• Applicants must submit their applications by 2018-03-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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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