NCT05985486 · RECRUITING
Brain Outcomes With Lifestyle Change in Down Syndrome
This trial is testing whether weight loss through a reduced-calorie diet can help protect the brains of adults with Down syndrome who do not yet have dementia. Half of participants will follow a structured diet program; the other half will receive general health education. Researchers will track cognition, brain imaging, and blood markers over 12 months. This is a Phase NA behavioral study, meaning it is evaluating a lifestyle approach rather than a drug.
You may qualify if
- Diagnosis of Down syndrome
- BMI of 25 to 50 kg/m2
- Ability to communicate through spoken language.
- Ability to come to the University of Kansas Medical Center 3 times across 1 year for outcomes testing
- Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner including providing transportation to our facilities for study assessments.
You're excluded if
- Diagnosis of dementia
- Insulin dependent diabetes
- Participation in a weight management program involving diet or physical activity in the past 6 mos.
- Dairy allergy
- Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
- Unwilling to be randomized
- Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position
- Use of GLP-1 medications
- Use of anti-amyloid medications
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-11