DeOndra Dixon INCLUDE Project Act of 2025
This bill, the DeOndra Dixon INCLUDE Project Act of 2025, would amend the Public Health Service Act to authorize and direct the National Institutes of Health (NIH) to run a dedicated program focused on Down syndrome and related co-occurring conditions. Known as the INCLUDE Project (Investigation of Co-occurring conditions across the Lifespan to Understand Down syndrome), the program would pursue research, training, and investigation across the lifespan of individuals with Down syndrome, aiming to better understand and address not only Down syndrome itself but also conditions that commonly appear alongside it (co-occurring conditions). The act emphasizes inclusive clinical trials, lifelong study cohorts, and exploration of biological mechanisms, while coordinating across NIH entities, avoiding duplication, and incorporating stakeholder input. It also requires biennial reports to Congress detailing the research activity and its real-world impact.
Key Points
- 1Establishes the INCLUDE Project within NIH to conduct research, training, and investigation related to Down syndrome.
- 2Program elements include:
- 3- High-risk, high-reward research on the effects of trisomy 21 on development and health.
- 4- Lifespan-focused cohorts and studies to understand Down syndrome and co-occurring conditions, and to develop new interventions.
- 5- Expanded clinical trials that include individuals with Down syndrome, plus trials for therapies aimed at improving daily living activities.
- 6- Research on biological mechanisms underlying structural, functional, and behavioral aspects, and growth issues.
- 7- Efforts to improve diagnosis and treatment of co-occurring conditions with Down syndrome, including biomarkers relevant to risk, diagnosis, and therapeutics.
- 8- Investigation into the causes and treatment of increased prevalence of co-occurring conditions such as Alzheimer's disease and autoimmunity.
- 9- Activities to improve quality of life for individuals with Down syndrome and their families.
- 10Coordination and non-duplication:
- 11- NIH institutes and centers must coordinate their Down syndrome-related activities and prioritize non-duplicative research where appropriate.
- 12Stakeholder engagement:
- 13- The Director of NIH should consult with patient advocates and other stakeholders to align activities with the needs of people with Down syndrome.
- 14Reporting to Congress:
- 15- Every two years, NIH must report on the research conducted or supported under this section, including which institute/center was involved, whether research was conducted directly or across multiple institutes, and any real-world evidence usable for clinical research and care.