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Behavioral Intervention

Lifestyle Changes for Brain Health in Down Syndrome (BOLD Trial)

N/A
Recruiting
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
Must not have
Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
Diagnosis of dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6, 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 25 and 45.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious health condition like cancer, recent heart attack, or stroke.
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I have been diagnosed with dementia.
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I use insulin to manage my diabetes.
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I am not willing to be assigned to a treatment by chance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neurofilament light
Plasma Amyloid beta 42:40 ratio
Weight
Secondary study objectives
Brain antioxidants
Brian Volume
Dietary Intake
+6 more
Other study objectives
Attendance at education sessions
Compliance with self-monitoring of diet
Height
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~4410
Diet
2000
Completed Phase 4
~15070

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
517 Previous Clinical Trials
177,217 Total Patients Enrolled

Media Library

Diet (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05985486 — N/A
Alzheimer's Disease Research Study Groups: General Health Education Control, Weight Loss
Alzheimer's Disease Clinical Trial 2023: Diet Highlights & Side Effects. Trial Name: NCT05985486 — N/A
Diet (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05985486 — N/A
~54 spots leftby Sep 2027
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