No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 64
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
81 (estimated)
Sponsor
University of Kansas Medical Center · Other
Who this trial is looking for
This trial is looking for adults with Down syndrome to see if losing weight or changing what they eat can help prevent Alzheimer's disease. Participants will join either a weight loss group or a health education group and visit a medical center three times over a year for tests.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Down syndrome
I have a BMI between 25 and 50
I can communicate using spoken language
I can visit the University of Kansas Medical Center three times in one year
I live at home with a parent or guardian, or in a supported living environment with a caregiver who helps with meals
You may not be able to join if
I have been diagnosed with dementia
I have insulin dependent diabetes
I have participated in a weight management program in the past 6 months
I have a dairy allergy
I have serious medical risks like cancer or a recent heart attack
I am not willing to be randomized
I have conditions that prevent me from having an MRI
I use GLP-1 medications or anti-amyloid medications
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed 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
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 educati…
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.
Trial Locations
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Status
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 enviro…
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
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