NCT05985486

Brain Outcomes With Lifestyle Change in Down Syndrome

The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Down Syndrome
• Alzheimer Disease
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Diet	A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
BEHAVIORAL	Health Education	Monthly health education sessions delivered remotely.

Timeline

• Start date: 2024-10-22
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2023-08-14
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States