Lifestyle Change for Brain Health in Down Syndrome

This study is looking at whether changes in diet and lifestyle can help prevent or delay Alzheimer's disease in adults with Down syndrome. You could be eligible if you are an adult with Down syndrome, aged 18-64, have a BMI (Body Mass Index) between 25 and 50, can speak, and live with a caregiver who helps with meals. Participants will either follow a reduced-calorie diet with frozen meals and increased fruits/vegetables, or receive general health education. Researchers will measure blood markers like Amyloid beta 42:40 ratio and Neurofilament light, as well as weight, to see if these lifestyle changes are helpful. The study aims to enroll 81 participants.

Study design
This is an interventional study where participants will be randomly assigned to either a weight loss group or a general health education group. The study plans to enroll 81 participants.
What's involved
You would need to come to the University of Kansas Medical Center 3 times over one year for testing. The weight loss group will follow a reduced energy diet, attend monthly remote education sessions, and self-monitor diet and weight. The control group will attend monthly remote general health education sessions.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken at the beginning of the study, and again at 6 and 12 months.

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NCT05985486

Brain Outcomes With Lifestyle Change in Down Syndrome

Recruiting
NAAges 18–64InterventionalPrevention
University of Kansas Medical Center
~81 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:DietHealth Education

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plasma Amyloid beta 42:40 ratio
Measured over Baseline, 6, 12 months
+2 more outcomes measured
Down Syndrome
Alzheimer Disease
Obesity
1 sites across 1 states
Kansas1

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Eligibility criteria

Inclusion

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

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
  • Plasma Amyloid beta 42:40 ratioBaseline, 6, 12 months

    Examines the amount of amyloid beta in a person's brain, measured by a blood draw.

  • Neurofilament lightBaseline, 6, 12 months

    Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.

  • WeightBaseline, 6, 12 months

    Examines how much a person weights, measured by standing on a scale.