Weight loss and dietary changes to prevent Alzheimer's in adults with Down syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate whether weight loss or dietary changes can help prevent or delay the onset of Alzheimer's Disease in adults with Down syndrome. Participants will be randomly assigned to either a weight loss group, which will follow a reduced energy diet and attend monthly remote education sessions, or a control group receiving general health education. Over the course of 12 months, all participants will visit the University of Kansas Medical Center three times for assessments including blood draws, cognitive testing, MRI scans, and evaluations of diet and body weight.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting

Study contacts

• Study coordinator: Lauren Ptomey, PhD
• Email: lptomey@kumc.edu
• Phone: 913-588-7982

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Levetiracetam to prevent seizures in adults with Down syndrome and Alzheimer's disease

  This trial will test whether the anti-seizure medicine levetiracetam can prevent tonic-clonic seizures and slow cognitive decline in adults over 40 who have Down syndrome and symptomatic Alzheimer's disease.

  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Granada, Andalusia and 4 other locations · NCT07234695

• Cholinergic Integrity in Down Syndrome and Aging

  This study tests a brain imaging tracer to see if cholinergic nerve health declines with age in adults with Down syndrome who may be at risk for Alzheimer's disease.

  Recruiting Phase 2 Vanderbilt University Medical Center · Nashville, Tennessee · NCT05231798

• Investigating the link between obesity and Alzheimer's disease

  This study is trying to see how being overweight or obese affects the risk of developing Alzheimer's disease in healthy adults aged 40-60.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT05077579

• Observational cohort for adults with Down syndrome and Alzheimer's disease

  This study is trying to understand how thinking skills relate to Alzheimer's disease signs in adults with Down syndrome to help plan future treatments.

  Recruiting at 18 sites University of Southern California · Phoenix, Arizona and 21 other locations · NCT04165109

• Ocular Changes in People Using Tirzepatide or Semaglutide

  This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07924618

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.