Brain outcomes with lifestyle change in adults with Down syndrome: Rationale and design for a 12-month randomized trial.
Lauren T Ptomey, Joseph E Donnelly, Jeffery Burns...
https://pubmed.ncbi.nlm.nih.gov/40329624Actively Recruiting
Phase Not Applicable
Age: 18Years - 64Years
All Genders
ID05985486
The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
Led by University of Kansas Medical Center · Updated on 2026-03-11
81
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether weight loss or changes in diet can help prevent or delay the development of Alzheimer's disease in adults with Down syndrome who do not have dementia. This study compares the effects of a reduced calorie diet and monthly behavioral counseling with general health education sessions delivered remotely. The goal is to better understand how lifestyle changes may influence Alzheimer's risk in this specific population. Participants will be randomly assigned to either a weight loss group or a general health education control group. The weight loss group will follow a reduced calorie diet focusing on frozen meals and increased fruits and vegetables linked to brain health, attend monthly remote education sessions, and self-monitor their diet and weight using web-based applications. The control group will participate in monthly remote sessions about general health topics. The study lasts 12 months. All participants will visit the University of Kansas Medical Center three times during the year for blood draws, cognitive tests, MRI brain scans, and assessments of height, weight, and dietary intake. Researchers will measure blood markers related to Alzheimer's disease, body weight, diet quality, brain volume, and cognitive function at baseline, 6 months, and 12 months. This allows comprehensive monitoring of health and brain outcomes throughout the study.
CONDITIONS
Brief Title
Brain Outcomes With Lifestyle Change in Down Syndrome
Who Can Participate
Age: 18Years - 64Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of Down syndrome
- Body Mass Index (BMI) between 25 and 50 kg/m2
- Ability to communicate through spoken language
- Ability to attend 3 visits at the University of Kansas Medical Center over 12 months for testing
- Living at home with a parent or guardian, or in supported living with a caregiver who assists with food shopping, meal planning, and preparation and agrees to help with study visits
You will not qualify if you...
- Diagnosis of dementia
- Insulin dependent diabetes
- Participation in a diet or physical activity weight management program in the past 6 months
- Dairy allergy
- Serious medical risks such as cancer, recent heart attack, stroke, pregnancy, or angioplasty
- Unwillingness to be randomized
- Contraindications for MRI, including metal implants, pacemakers, claustrophobia, or inability to lie flat
- Use of GLP-1 medications
- Use of anti-amyloid medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Outpatient Treatment
Duration - 12 months
Participants follow a reduced calorie diet daily for 12 months with monthly behavioral counseling and education sessions, or attend monthly health education sessions about general health.
Monthly visits for education and counseling
Trial Site Locations
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
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Research Team
L
Lauren Ptomey, PhD
J
Jessica Danon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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