Diet-based weight loss and brain health in Down syndrome
Studies a weight loss diet and Alzheimer's risk in Down syndrome.
Key facts
- Who runs it
- University of Kansas Medical Center
- Where
- Kansas City, United StatesSee the site
- Trial code
- Registry title
- Brain Outcomes With Lifestyle Change in Down Syndrome
- Status
- Recruiting
- People taking part
- 81 people, planned
- Started
- 22 Oct 2024
- Expected to end
- 30 Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Diet
- Health Education
- Record updated
- 11 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Down syndrome, without dementia, who are overweight or obese. It tests whether weight loss can help prevent or delay Alzheimer's disease.
- Age
- 18 to 64 years
- Sex
- Men and women
- Disease stage
- Down syndrome without dementia; BMI of 25 to 50 kg/m2
- Earlier treatment
- No diet or physical activity weight management program in the past 6 months. No use of GLP-1 medications or anti-amyloid medications.
Main reasons for not taking part
- Diagnosis of dementia
- Insulin dependent diabetes
- Dairy allergy
- Serious medical risk (for example cancer, recent heart attack, stroke, pregnancy, angioplasty)
- Cannot have an MRI (for example metal implants, pacemaker, claustrophobia)
This trial only enrols participants with Down syndrome. The registry sentence this rests on: Diagnosis of Down syndrome
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Diagnosis of dementia
- Insulin dependent diabetes
- Dairy allergy
- Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
- Participation in a weight management program involving diet or physical activity in the past 6 mos
- Unwilling to be randomized
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in United States
- University of Kansas Medical CenterKansas City, United StatesContact: Lauren Ptomey, PhDTaking people
About the trial
What the trial wants to find out
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
Read full original descriptionShow less
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.
The 2 groups in the trial
- Weight LossTreatment being tested
* Follow a reduced calorie diet daily for 12 months. * Attend monthly behavioral counseling/education
Treatment: Diet and Health Education
- General Health Education ControlExisting treatment, for comparison
\- Attend monthly health education sessions about general health.
Treatment: Health Education
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
- Plain-language title
- Diet-based weight loss and brain health in Down syndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05985486, who can take part
- Record updated
- 11 March 2026