Clinical trial NCT05985486: Brain Outcomes With Lifestyle Change in Down Syndrome
Official title: The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Alzheimer Disease
Obesity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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

Primary outcomes:
measure: Plasma Amyloid beta 42:40 ratio
timeFrame: Baseline, 6, 12 months
measure: Neurofilament light
timeFrame: Baseline, 6, 12 months
measure: Weight
timeFrame: Baseline, 6, 12 months
Secondary outcomes:
measure: Dietary Intake
timeFrame: Baseline, 6, 12 months
measure: Skin carotenoid content
timeFrame: Baseline, 6, 12 months
measure: Plasma Phosphorylated Tau
timeFrame: Baseline, 6, 12 months
measure: Glial Fibrillary Acidic Protein
timeFrame: Baseline, 6, 12 months
measure: Brian Volume
timeFrame: Baseline, 12 months
measure: Brain antioxidants
timeFrame: Baseline, 12 months
measure: The modified Cued Recall Test
timeFrame: Baseline, 6, 12 months
measure: The Modified Cats and Dogs Task
timeFrame: Baseline, 6, 12 months
measure: Down Syndrome Mental Status Examination
timeFrame: Baseline, 6, 12 months
Other outcomes:
measure: Height
timeFrame: Baseline, 6, 12 months
measure: Waist circumference
timeFrame: Baseline, 6, 12 months
measure: Attendance at education sessions
timeFrame: Across 12 months
measure: Compliance with self-monitoring of diet
timeFrame: Across 12 months
measure: Physical Activity
timeFrame: Baseline, 6, 12 months
measure: Structured interviews
timeFrame: 12 months
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References: