Image

Brain Outcomes With Lifestyle Change in Down Syndrome

Brain Outcomes With Lifestyle Change in Down Syndrome

Recruiting
18-64 years
All
Phase N/A

Powered by AI

Overview

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

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

Study details
    Down Syndrome
    Alzheimer Disease
    Obesity

NCT05985486

University of Kansas Medical Center

23 May 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.