RECRUITING

Brain Outcomes With Lifestyle Change in Down Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-22
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05985486

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of Down syndrome
  2. * BMI of 25 to 45 kg/m2
  3. * Ability to communicate through spoken language.
  4. * Ability to come to the University of Kansas Medical Center 3 times across 1 year for outcomes testing
  5. * 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.
  1. * Diagnosis of dementia
  2. * Insulin dependent diabetes
  3. * Participation in a weight management program involving diet or physical activity in the past 6 mos.
  4. * Dairy allergy
  5. * Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
  6. * Unwilling to be randomized
  7. * Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position
  8. * Use of GLP-1 medications
  9. * Use of anti-amyloid medications

Contacts and Locations

Study Contact

Lauren Ptomey, PhD
CONTACT
913-588-7982
lptomey@kumc.edu
Jessica Danon
CONTACT
785-764-3574
jdanon@kumc.edu

Study Locations (Sites)

University of Kansas Medical Center
Kansas City, Kansas, 66160
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

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

Study Start Date2024-10-22
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2024-10-22
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Down Syndrome
  • Alzheimer Disease
  • Obesity