NCT05985486 Brain Outcomes With Lifestyle Change in Down Syndrome
| NCT ID | NCT05985486 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kansas Medical Center |
| Condition | Down Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 81 participants in total. It began in 2024-10-22 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05985486 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Down Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05985486 currently recruiting?
Yes, NCT05985486 is actively recruiting participants. Contact the research team at lptomey@kumc.edu for enrollment information.
Where is the NCT05985486 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT05985486 clinical trial?
NCT05985486 is sponsored by University of Kansas Medical Center. The trial plans to enroll 81 participants.