Status:
RECRUITING
Brain Outcomes With Lifestyle Change in Down Syndrome
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Down Syndrome
Alzheimer Disease
Eligibility:
All Genders
18-64 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT05985486
Start Date
October 22 2024
End Date
September 30 2027
Last Update
May 16 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160