Blood Brain Barrier Response to Antibodies Targeting Beta-Amyloid (R01 - Clinical Trial Not Allowed) | PAR 22 235

Opportunity Information: Apply for PAR 22 235

The National Institutes of Health (NIH) is offering an R01 research grant opportunity titled "Blood Brain Barrier Response to Antibodies Targeting Beta-Amyloid (R01 - Clinical Trial Not Allowed)" (Funding Opportunity Number PAR 22-235). The scientific focus is on understanding why and how brain blood vessels and the blood-brain barrier (BBB) respond to passive immunotherapies that use antibodies against beta-amyloid, particularly when those responses lead to amyloid-related imaging abnormalities (ARIA). In practical terms, the program is aimed at uncovering the cellular and molecular events triggered in the neurovascular unit during anti-beta-amyloid antibody treatment, with the longer-term objective of identifying mechanisms that could be targeted to prevent or reduce vascular injury and BBB disruption while patients receive therapies intended to clear or neutralize beta-amyloid.

This opportunity is centered on discovery and mechanistic research rather than testing interventions in people, which is reflected in the "Clinical Trial Not Allowed" designation. Projects should be designed to establish a clearer biological explanation for ARIA in the context of passive anti-beta-amyloid immunotherapy, including what happens in and around cerebral blood vessels when antibodies engage amyloid deposits. The underlying motivation is that anti-beta-amyloid therapies have advanced clinically, but ARIA remains a major safety and tolerability issue; by mapping the molecular pathways and cell types involved, researchers can point to strategies that preserve BBB integrity and protect brain vasculature during treatment. The initiative therefore encourages studies that connect vascular biology, immunology, and neurodegeneration, with an emphasis on mechanisms that are plausibly actionable for future protective approaches.

From an administrative standpoint, this is a discretionary federal funding opportunity using the grant mechanism, categorized under health research and associated with CFDA numbers 93.853 and 93.866. The posted award ceiling is $500,000, indicating the maximum annual budget level NIH expects to support under this announcement (actual awarded amounts typically depend on scope, justification, and NIH policies). The original closing date listed for the opportunity was November 10, 2022, and the opportunity record indicates a creation date of August 25, 2022.

Eligibility is broad across U.S.-based research and public service organizations. Eligible applicants include state, county, and local 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

There are important constraints related to foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain eligible international elements (for example, specific collaborations or performance sites) if they meet NIH definitions and requirements and are justified scientifically.

Overall, this funding opportunity is best viewed as a targeted NIH effort to fill a key knowledge gap at the intersection of Alzheimer’s therapeutics and cerebrovascular biology: determining the mechanistic basis of BBB and blood vessel responses to anti-beta-amyloid antibodies that culminate in ARIA, and using that understanding to lay a foundation for approaches that make amyloid-targeting treatments safer for the brain’s vascular system.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Blood Brain Barrier Response to Antibodies Targeting Beta-Amyloid (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 2022-08-25.
• Applicants must submit their applications by 2022-11-10. (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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