Grant name: Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01)
Funding organization: U.S. Food and Drug Administration (FDA)
Total funding amount: Up to $900,000 per year
Duration: Maximum of four years
Primary objective: Support clinical trials for rare neurodegenerative diseases
Key stakeholders: FDA, higher education institutions, nonprofits, for-profit organizations, government entities
Funding source: Federal government
Grant frequency: Recurring
Higher Education Institutions
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits with and without 501(c)(3) IRS Status
For-Profit Organizations (including Small Businesses)
Local, State, County, and City Governments
Indian/Native American Tribal Governments
Federal Governments
Foreign Organizations
Active registration in System for Award Management (SAM)
Unique Entity Identifier (UEI)
eRA Commons account for all Program Directors/Principal Investigators
Clinical trials for rare neurodegenerative diseases
Innovative trial designs (e.g., seamless, adaptive, basket, umbrella, platform trials)
Patient engagement in trial design
Experience in conducting clinical trials
Knowledge of rare neurodegenerative diseases
Maximum budget per year: $650,000 for years 1-4
Additional funding for innovative trial approaches: Up to $250,000 per year
Application due date: October 21, 2025
Earliest start date: July 2025
Expiration date: October 24, 2025
Compliance with HHS Grants Policy Statement
Protection of human subjects as per 45 CFR 46
Applications must be submitted electronically via Grants.gov
Follow SF424 (R&R) Application Guide instructions