Integrative Research to Understand the Impact of Sex Differences on the Molecular Determinants of AD Risk and Responsiveness to Treatment (R01 Clinical Trial Optional) | PAR 20 269

Opportunity Information: Apply for PAR 20 269

The National Institutes of Health (NIH) grant opportunity PAR-20-269, titled "Integrative Research to Understand the Impact of Sex Differences on the Molecular Determinants of AD Risk and Responsiveness to Treatment (R01 Clinical Trial Optional)," supports research projects that explain, in a mechanistic and integrated way, how biological sex influences Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD). The central goal is not just to document that males and females differ in risk or symptoms, but to uncover the molecular and biological drivers of those differences across the full trajectory of brain aging. NIH is looking for cross-disciplinary, team-based applications that can connect mechanisms (for example, molecular pathways, cellular processes, genetics, endocrinology, immunology, and brain systems) to observable outcomes such as aging patterns, clinical phenotypes, and eventual AD/ADRD risk.

A major emphasis of this FOA is precision medicine: understanding whether and why prevention strategies and treatments work differently in males and females. This includes responsiveness to both pharmacologic interventions (drugs, biologics, therapeutic agents) and non-pharmacologic interventions (such as lifestyle, behavioral, cognitive, or other non-drug approaches). The intent is to encourage research that can move beyond one-variable explanations and instead integrate multiple levels of evidence to explain sex-linked variability in disease onset, progression, and treatment response. Projects are expected to be mechanistic in nature, meaning they should aim to identify causal pathways or clearly defined biological processes that account for sex differences, rather than only describing associations.

The mechanism is an NIH R01 research project grant, and clinical trials are optional under this announcement, meaning applicants may propose studies that include a clinical trial component if it is scientifically justified, but they are not required to do so. The funding activity category is health, and the associated CFDA number is 93.866. The award ceiling listed for the opportunity is $750,000. The FOA was created on July 17, 2020, with an original closing date of July 24, 2020.

Eligibility is broad and includes many types of U.S. organizations and governments: 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 and tribal governments that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education when applicable); for-profit organizations other than small businesses; and small businesses. In addition, NIH explicitly lists other 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 government agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).

Overall, this FOA is designed for research teams that can bring together complementary expertise to explain how sex differences shape molecular determinants of AD/ADRD risk and brain aging, and to translate those insights into more targeted, sex-informed approaches to prevention and treatment. The strongest-fit applications would typically be those that link biological mechanisms to clinically meaningful outcomes and that are structured to produce findings that can guide future therapeutic development, intervention tailoring, or improved prediction of who is at risk and who is likely to benefit from specific interventions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Integrative Research to Understand the Impact of Sex Differences on the Molecular Determinants of AD Risk and Responsiveness to Treatment (R01 Clinical Trial Optional)" 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 2020-07-17.
• Applicants must submit their applications by 2020-07-24. (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 $750,000.00 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.

Apply for PAR 20 269

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