Brain Outcomes With Lifestyle Change in Down Syndrome (BOLD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Alzheimer Disease; Down Syndrome
• Intervention / Treatment: Behavioral: Diet; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Ptomey, PhD; Phone Number: 913-588-7982; Email: lptomey@kumc.edu
• Study Contact Backup: Name: Jessica Danon; Phone Number: 785-764-3574; Email: jdanon@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Lauren Ptomey, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
Brian Volume	Examines how much white and grey matter a person has in their brain, measured by MRI	Baseline, 12 months
Brain antioxidants	Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI	Baseline, 12 months
The modified Cued Recall Test	Measures cognitive function. Twelve items are presented for learning, 4 at a time, with each item accompanied by a unique category cue. The testing phase consists of 3 trials. Each trial begins with free recall of the test items; following free recall, a category cue is provided for those items not spontaneously recalled.	Baseline, 6, 12 months
The Modified Cats and Dogs Task	Measures executive function. The task measures the ability to inhibit a natural response (naming the pictures of a dog, as "dog") and to replace it with an incongruent one (naming the pictures of a dog as "cat").	Baseline, 6, 12 months
Down Syndrome Mental Status Examination	Provides an omnibus measure of neuropsychological functioning, assessing recall of personal information, orientation, immediate and delayed memory, language, visuospatial function and praxis.	Baseline, 6, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Examines how tall a person is, measured on a stadiometer	Baseline, 6, 12 months
Waist circumference	Examines the distance around the smallest part of a person's torso, measured with a measuring tape	Baseline, 6, 12 months
Attendance at education sessions	Examines how often individuals attendance the monthly education sessions. Obtained from interventionist records and expressed as the percentage of possible sessions attended.	Across 12 months
Compliance with self-monitoring of diet	Assessed as the percentage of days a person tracked what they ate across the study.	Across 12 months
Physical Activity	Examines Daily minutes of light, moderate, and vigorous physical activity as well as sedentary time using an ActiGraph tri-axial accelerometer worn on a wrist for 7 days.	Baseline, 6, 12 months
Structured interviews	A 20% random sample of participants and study partners from each intervention arm will complete a 30 minute interview to gather information that might be useful for improving the intervention.	12 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Nutrition Disorders; Genetic Diseases, Inborn; Overnutrition; Body Weight; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Congenital Abnormalities; Abnormalities, Multiple; Overweight; Intellectual Disability; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Alzheimer Disease; Down Syndrome; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet
• Other Study ID Numbers: Study 150542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No