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Brain Outcomes With Lifestyle Change in Down Syndrome

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether weight loss or diet changes can help prevent or delay Alzheimer’s disease in adults with Down syndrome who do not have dementia. Participants are placed by chance in a weight loss group or a general health education group, with monthly online sessions. Everyone visits the University of Kansas Medical Center 3 times over 1 year for blood tests, thinking tests, MRI scans, and diet and body measurements.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Down syndrome.
  • Have a BMI of 25 to 50. BMI is a measure of weight compared with height.
  • Be able to communicate by speaking.
  • Be able to visit the University of Kansas Medical Center 3 times over 1 year.
  • Live with a parent or guardian, or in supported housing with a caregiver. This person must help with food shopping, meal planning, and cooking, and agree to be a study partner and provide rides to study visits.

Who can't join

  • Have dementia, a condition that affects memory and thinking.
  • Have diabetes that requires insulin.
  • Have taken part in a weight management program involving diet or exercise in the past 6 months.
  • Have a dairy allergy.
  • Have a serious medical risk, such as cancer, a recent heart attack, stroke, pregnancy, or angioplasty (a procedure to open narrowed blood vessels).
  • Do not agree to be placed in a study group by chance.
  • Cannot have an MRI because of unsafe metal implants or devices, such as certain pacemakers; fear of enclosed spaces; or inability to lie flat on your back.
  • Use GLP-1 medicines, which treat diabetes or help with weight loss, or anti-amyloid medicines, which target a protein linked to Alzheimer’s disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

KS