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Behavioral Intervention
Lifestyle Changes for Brain Health in Down Syndrome (BOLD Trial)
N/A
Waitlist Available
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI of 25 to 45 kg/m2
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6, 12 months
Awards & highlights
BOLD Trial Summary
This trial aims to see if weight loss can help prevent or delay Alzheimer's for adults with Down syndrome.
Who is the study for?
This trial is for adults with Down syndrome who are overweight, can speak, and live at home or in supported living. They need a caregiver to help with meals and transport to the University of Kansas Medical Center three times over a year. People with dementia, insulin-dependent diabetes, recent serious medical issues, dairy allergies, or MRI contraindications cannot join.Check my eligibility
What is being tested?
The study tests if weight loss through diet changes prevents Alzheimer's in adults with Down syndrome. Participants will be randomly placed into two groups: one on a reduced energy diet using web apps for monitoring and another receiving general health education.See study design
What are the potential side effects?
There may not be direct side effects from the interventions as they involve dietary changes and health education sessions. However, participants should consider potential discomforts like hunger due to calorie restriction or stress related to lifestyle adjustments.
BOLD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 25 and 45.
BOLD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurofilament light
Plasma Amyloid beta 42:40 ratio
Weight
Secondary outcome measures
Brain antioxidants
Brian Volume
Cognitive Function
+4 moreOther outcome measures
Attendance at education sessions
Compliance with self-monitoring of diet
Height
+3 moreBOLD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Weight LossExperimental Treatment2 Interventions
Follow a reduced calorie diet daily for 12 months.
Attend monthly behavioral counseling/education
Group II: General Health Education ControlActive Control1 Intervention
- Attend monthly health education sessions about general health.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health Education
2014
Completed Phase 3
~4010
Diet
2000
Completed Phase 4
~15300
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
461 Previous Clinical Trials
169,076 Total Patients Enrolled
19 Trials studying Obesity
103,531 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to dairy.You have been diagnosed with Down syndrome.You have been in a weight management program involving diet or exercise in the last 6 months.My BMI is between 25 and 45.I live with someone who helps me with meals and can take me to my study visits.You cannot have an MRI because you have metal implants, a pacemaker, or feel too anxious in small spaces.I have a serious health condition like cancer, recent heart attack, or stroke.I have been diagnosed with dementia.I use insulin to manage my diabetes.I am not willing to be assigned to a treatment by chance.
Research Study Groups:
This trial has the following groups:- Group 1: General Health Education Control
- Group 2: Weight Loss
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollees still being welcomed into this research protocol?
"According to the information on clinicaltrials.gov, no new patients are being recruited for this trial which was initially uploaded in October of 2024 and last updated eight months ago. However, there remain 2,920 other trials actively seeking participants."
Answered by AI
Am I eligible to join the research team for this experiment?
"This trial requires that applicants have Alzheimer's disease, and are between 18 to 64 years old. 81 individuals will be chosen for the study."
Answered by AI
Does this research project have an age limitation?
"This trial is open to individuals aged 18-64. For those outside of this age range, there are 570 studies for minors and 2122 trials available for seniors."
Answered by AI
What goals are researchers hoping to realize with this trial?
"Over the course of this clinical trial, which spans Baseline to 6 and 12 months respectively, Neurofilament light will be used as a primary measure. Brain Volume (via MRI), Brain Antioxidants (also via MRI) and Dietary Intake (through 3 days of food logging) are all secondary outcomes being monitored."
Answered by AI
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