Weight loss and dietary changes to prevent Alzheimer's in adults with Down syndrome
The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
This study is testing if losing weight or changing diets can help prevent or delay Alzheimer's in adults with Down syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT05985486 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether weight loss or dietary changes can help prevent or delay the onset of Alzheimer's Disease in adults with Down syndrome. Participants will be randomly assigned to either a weight loss group, which will follow a reduced energy diet and attend monthly remote education sessions, or a control group receiving general health education. Over the course of 12 months, all participants will visit the University of Kansas Medical Center three times for assessments including blood draws, cognitive testing, MRI scans, and evaluations of diet and body weight.
Who should consider this trial
Good fit: Ideal candidates are adults with Down syndrome who have a BMI between 25 and 50 and can communicate verbally.
Not a fit: Patients with a diagnosis of dementia or serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to delaying Alzheimer's Disease in adults with Down syndrome through lifestyle modifications.
How similar studies have performed: While there have been studies on lifestyle changes in other populations, this specific approach in adults with Down syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Lauren Ptomey, PhD
- Email: lptomey@kumc.edu
- Phone: 913-588-7982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.