Brain Outcomes With Lifestyle Change in Down Syndrome

NCT05985486 | Recruiting DMC

• 1 other identifier: Study 150542
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Down Syndrome; Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Dietary Intake

  Baseline, 6, 12 months

• Skin carotenoid content

  Baseline, 6, 12 months

• Plasma Phosphorylated Tau

  Baseline, 6, 12 months

• Glial Fibrillary Acidic Protein

  Baseline, 6, 12 months

• Brian Volume

  Baseline, 12 months

Other Outcomes (6)

• Height

  Baseline, 6, 12 months

• Waist circumference

  Baseline, 6, 12 months

• Attendance at education sessions

  Across 12 months

Study Arms (2)

Weight Loss

EXPERIMENTAL

* Follow a reduced calorie diet daily for 12 months. * Attend monthly behavioral counseling/education

Behavioral: Diet; Behavioral: Health Education

General Health Education Control

ACTIVE COMPARATOR

\- Attend monthly health education sessions about general health.

Behavioral: Health Education

Interventions

Diet BEHAVIORAL

A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.

Weight Loss

Health Education BEHAVIORAL

Monthly health education sessions delivered remotely.

General Health Education Control; Weight Loss

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Down Syndrome; Alzheimer Disease; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Lauren Ptomey, PhD

CONTACT

913-588-7982; lptomey@kumc.edu

Jessica Danon

CONTACT

785-764-3574; jdanon@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: October 22, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)