Development and Validation of Human Cellular Models for Alzheimer's Disease-Related Dementias (ADRD) (R01 - Clinical Trial Not Allowed)

Background
The National Institutes of Health (NIH) is issuing a Notice of Funding Opportunity (NOFO) to support the development and validation of novel, complex, and pathophysiologically relevant human cellular models of Alzheimer's Disease-Related Dementias (ADRD). The cellular model system needs to reflect multiple aspects of the human condition as much as possible, such as capturing the multiple pathologies and brain cell types observed in ADRD. Validation is required, including face and construct validity. Human cellular models could be developed and validated with the goal of supporting therapeutic development or better understanding of human disease mechanisms and mechanisms that cause predisposition or resilience to developing ADRD.

Grant Details
This NOFO supports the development and validation of novel clinically- and/or pathophysiologically-relevant human cellular models of ADRD. The cellular model systems would be expected to capture the multi-faceted pathologies and multiple cell types observed in ADRDs. Validation includes internal, face, construct, and predictive (to the extent possible) validation. Multidisciplinary teams will be highly encouraged. Leveraging the use of and depositing new cells into existing NIH cell repository resources will also be encouraged.

Eligibility Requirements
All organizations administering an eligible parent award may apply for a supplement under this NOFO. Eligible entities include higher education institutions, nonprofits, for-profit organizations, state and local governments, federally recognized Indian/Native American tribal governments, federal agencies, U.S. territories or possessions, public housing authorities/Indian housing authorities, faith-based or community-based organizations.

Period of Performance
The project period is determined by the scope of the proposed project but should not exceed five years. The earliest start date for the project is June 20, 2024.

Grant Value
NIH intends to commit a total budget of up to $4,500,000 in FY2025 to fund up to six awards, contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are limited to no more than $500,000 direct costs per year.