Brain Outcomes With Lifestyle Change in Down Syndrome

NOT_YET_RECRUITING

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The goal of this study is to determine if weight loss or changes 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

🗓️ Study Start (Actual) 1 October 2024

🗓️ Primary Completion (Estimated) 30 September 2027

✅ Study Completion (Estimated) 30 September 2027

👥 Enrollment (Estimated) 81

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Kansas City, Kansas, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Diagnosis of Down syndrome
* BMI of 25 to 45 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

Ages Eligible for Study: 18 Years to 64 Years (ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 2 August 2023
First Submitted that Met QC Criteria 2 August 2023
First Posted 14 August 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 28 November 2023
Last Update Posted 29 November 2023
Last Verified November 2023