NCT05985486Recruiting
Brain Outcomes With Lifestyle Change in Down Syndrome
The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
The goal of this study is to determine if weight loss or changes in dietary intake can help prevent of delay adults with Down syndrome from developing Alzheimer's Disease Adults with Down syndrome without dementia will be randomized to either a weight loss group or a general health education control group. The weight loss group will be asked to follow a reduced energy diet, attend monthly education sessions delivered remotely and self-monitor diet and body weight using commercially available web-based applications. The control group will be asked to attend remotely delivered monthly education sessions on general health education topics. All participants will come to the University of Kansas Medical Center, 3 times across 12 months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and assessment of diet intake.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- First submitted
- 2 Aug 2023
- Start date
- 22 Oct 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- Obesity, Alzheimer disease
- NCT number
- NCT05985486
What you commit to
- Study type: Interventional
- Planned participants: 81
- From 22 Oct 2024 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Diagnosis of dementia
- Insulin dependent diabetes
- Dairy allergy
- Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
Other
- Participation in a weight management program involving diet or physical activity in the past 6 mos.
- Unwilling to be randomized
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.