NIH Launches New Research Project Focused on Down Syndrome, Mandating Lifespan Studies and Increased Clinical Trials

The newly proposed DeOndra Dixon INCLUDE Project Act of 2025 is straightforward: it creates a massive, dedicated research program within the National Institutes of Health (NIH) focused entirely on Down syndrome. This new initiative, officially named the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project (INCLUDE), is tasked with driving research, training, and investigation specifically for individuals with Down syndrome, also known as trisomy 21. The bill mandates that the NIH Director oversee this project, focusing on everything from basic biology to improving everyday quality of life.

The Research Mandate: Closing the Gaps

This isn't just a general funding boost; the bill sets specific research requirements. The INCLUDE Project must fund "high-risk, potentially high-reward research" to understand how that extra chromosome affects human development and health. Crucially, it demands lifespan studies—meaning research must cover individuals with Down syndrome across their entire lives, not just childhood. This includes setting up large group studies (cohort studies) to better track health issues over time. For families, this means the research pipeline is intended to be continuous, following individuals from birth through old age.

Tackling Co-occurring Conditions and Clinical Trials

Perhaps the most impactful requirement is the focus on co-occurring conditions. People with Down syndrome often face higher risks for specific health issues, notably Alzheimer's disease, dementia, and certain autoimmune disorders. The bill explicitly requires the NIH to research better ways to diagnose and treat these conditions, including identifying early risk factors (biomarkers). This is huge because it targets the specific health challenges that often lead to significant caregiving demands and reduced quality of life later on.

Furthermore, the bill requires the NIH to actively work on increasing the number of clinical trials that include people with Down syndrome or are specifically designed for them. For researchers and pharmaceutical companies, this means a clear federal signal that this population needs to be included in testing new drugs and therapies aimed at improving daily living activities. For families, it means potentially greater access to cutting-edge treatments that have been properly tested for their loved ones.

Making Sure the NIH Plays Nice

One common issue in large federal agencies is duplication of effort. The bill addresses this by tasking the NIH Director with a strict coordination duty. They must ensure that all the different institutes and centers within the NIH—the ones focused on aging, mental health, child health, etc.—are communicating and prioritizing studies that don't overlap or duplicate existing work. This is the government version of making sure the left hand knows what the right hand is doing, ensuring taxpayer money is spent efficiently on new discoveries.

Finally, the NIH Director is required to consult with relevant groups, like patient advocates, when carrying out these activities. The bill states this should happen "whenever it makes sense and is feasible." While that language gives the NIH some wiggle room, the intent is clear: the research must reflect the real-world needs of individuals with Down syndrome and their families. To keep everyone accountable, the NIH must then report back to Congress every two years, detailing all the research conducted and identifying any real-world evidence that could be used for future clinical studies or medical care.