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Recruiting NCT05985486

Brain Outcomes With Lifestyle Change in Down Syndrome

No phase Interventional Down Syndrome Alzheimer Disease Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diet, Health Education.
Who it may be relevant to
Registry conditions: Down Syndrome, Alzheimer Disease, Obesity. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Diet
    A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
  • Behavioral Health Education
    Monthly health education sessions delivered remotely.

Primary outcome measures

  • Plasma Amyloid beta 42:40 ratio [Time frame: Baseline, 6, 12 months]
  • Neurofilament light [Time frame: Baseline, 6, 12 months]
  • Weight [Time frame: Baseline, 6, 12 months]
Secondary outcome measures (9)
  • Dietary Intake [Time frame: Baseline, 6, 12 months]
  • Skin carotenoid content [Time frame: Baseline, 6, 12 months]
  • Plasma Phosphorylated Tau [Time frame: Baseline, 6, 12 months]
  • Glial Fibrillary Acidic Protein [Time frame: Baseline, 6, 12 months]
  • Brian Volume [Time frame: Baseline, 12 months]
  • Brain antioxidants [Time frame: Baseline, 12 months]
  • The modified Cued Recall Test [Time frame: Baseline, 6, 12 months]
  • The Modified Cats and Dogs Task [Time frame: Baseline, 6, 12 months]
  • Down Syndrome Mental Status Examination [Time frame: Baseline, 6, 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Kansas Medical Center — Kansas City

Publications

  • Ptomey LT, Donnelly JE, Burns J, Morris J, Hartley S, Martin LE, Choi IY, Lee P, Li Y, Hunt S, Sherman JR, Danon JC, Brucks MG, Koon L, Spaeth K, Sullivan DK. Brain outcomes with lifestyle change in adults with Down syndrome: Rationale and design for a 12-month randomized trial. Alzheimers Dement. 2025 Apr;21(4):e70219. doi: 10.1002/alz.70219. PMID 40329624

Identifiers

NCT: NCT05985486 · Study 150542

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗