Brain Outcomes With Lifestyle Change in Down Syndrome

Study Overview
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Brief Summary
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The goal of this study is to determine if weight loss or changes 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.

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

Conditions
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Down Syndrome, Alzheimer Disease, Obesity

Intervention / Treatment
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* Behavioral: Diet
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Down syndrome BMI of 25 to 45 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Loss<br>Follow a reduced calorie diet daily for 12 months. Attend monthly behavioral counseling/education | Behavioral: Diet<br>* A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.<br>Behavioral: Health Education<br>* Monthly health education sessions delivered remotely.<br>|
| Active Comparator: General Health Education Control<br>- Attend monthly health education sessions about general health. | Behavioral: Health Education<br>* Monthly health education sessions delivered remotely.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Amyloid beta 42:40 ratio | Examines the amount of amyloid beta in a person's brain, measured by a blood draw. | Baseline, 6, 12 months | 
| Neurofilament light | Examines the amount of Neurofilament light in a person's brain, measured by a blood draw. | Baseline, 6, 12 months | 
| Weight | Examines how much a person weights, measured by standing on a scale. | Baseline, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function | Examines cognitive function measured using the National Alzheimer's Coordinating Center's DS Module. | Baseline, 6, 12 months | 
| Brian Volume | Examines how much white and grey matter a person has in their brain, measured by MRI | Baseline, 6, 12 months | 
| Brain antioxidants | Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI | Baseline, 6, 12 months | 
| Dietary Intake | Examines what someone is eating, measured by writing down what a person eats over 3 days. | Baseline, 6, 12 months | 
| Skin carotenoid content | Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter. | Baseline, 6, 12 months | 
| Plasma Phosphorylated Tau | Examines the amount of Tau in a person's brain, collected by a blood draw. | Baseline, 6, 12 months | 
| Glial Fibrillary Acidic Protein | Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw. | Baseline, 6, 12 months |