The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
Weight loss study for adults with Down syndrome to prevent Alzheimer's
Plain English Summary
Brain Outcomes With Lifestyle Change in Down Syndrome is a Not Applicable clinical trial sponsored by University of Kansas Medical Center studying Down Syndrome, Alzheimer Disease, Obesity. This study tests if losing weight or changing diet can help prevent or delay Alzheimer's disease in adults with Down syndrome. It is for adults with Down syndrome who do not have dementia and have a BMI between 25 and 50. Participants will be randomly assigned to a weight loss program or a general health education group, involving monthly remote sessions and in-person visits for tests. Alternatives include maintaining current lifestyle or other general health improvement strategies. The trial aims to enroll 81 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with Down syndrome and a BMI between 25 and 50 can join. You must be able to speak, come to the study center 3 times over a year, and have a caregiver who can help with food and transportation. Individuals with dementia, insulin-dependent diabetes, dairy allergies, or certain serious medical conditions cannot participate. People currently on weight management programs, using specific medications (GLP-1 or anti-amyloid), or unable to undergo MRI scans are also excluded. This trial is studying Down Syndrome, Alzheimer Disease, Obesity, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure changes in specific proteins in the blood (amyloid beta and neurofilament light) and body weight, which are indicators of brain health and the effectiveness of the weight The specific primary outcome measures are: Plasma Amyloid beta 42:40 ratio (Baseline, 6, 12 months); Neurofilament light (Baseline, 6, 12 months); Weight (Baseline, 6, 12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a critical gap in understanding how lifestyle changes like weight loss can impact the risk of Alzheimer's disease, a condition disproportionately affecting adults with Down syndro This research targets Down Syndrome, Alzheimer Disease, Obesity, where improved treatment options are needed.
Investor Insight
This trial signals a growing interest in preventative strategies for neurodegenerative diseases in specific populations, potentially opening new markets for lifestyle interventions and related health
Is This Trial Right for Me?
Ask your doctor if this study is right for you and what the potential risks and benefits are. You will attend monthly online health education sessions and visit the study center three times over 12 months for blood draws, cognitive tests, MRI scans, and weight measurements. The weight loss group will follow a reduced-calorie diet using pre-purchased meals and track their progress online. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 81 participants
Interventions
- 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.
Primary Outcomes
- Plasma Amyloid beta 42:40 ratio (Baseline, 6, 12 months)
- Neurofilament light (Baseline, 6, 12 months)
- Weight (Baseline, 6, 12 months)
Secondary Outcomes
- 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)
Full 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
Trial Locations
- University of Kansas Medical Center, Kansas City, Kansas, United States
Frequently Asked Questions
What is clinical trial NCT05985486?
NCT05985486 is a Not Applicable INTERVENTIONAL study titled "Brain Outcomes With Lifestyle Change in Down Syndrome." It is currently recruiting and is sponsored by University of Kansas Medical Center. The trial targets enrollment of 81 participants.
What conditions does NCT05985486 study?
This trial investigates treatments for Down Syndrome, Alzheimer Disease, Obesity. The primary condition under study is Down Syndrome.
What treatments are being tested in NCT05985486?
The interventions being studied include: Diet (BEHAVIORAL), Health Education (BEHAVIORAL). A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
What does Not Applicable mean for NCT05985486?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05985486?
This trial is currently "Recruiting." It started on 2024-10-22. The estimated completion date is 2027-09-30.
Who is sponsoring NCT05985486?
NCT05985486 is sponsored by University of Kansas Medical Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05985486?
The trial aims to enroll 81 participants. The trial is currently recruiting and accepting new participants.
How is NCT05985486 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05985486?
The primary outcome measures are: Plasma Amyloid beta 42:40 ratio (Baseline, 6, 12 months); Neurofilament light (Baseline, 6, 12 months); Weight (Baseline, 6, 12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05985486 being conducted?
This trial is being conducted at 1 site, including Kansas City, Kansas (United States).
Where can I find official information about NCT05985486?
The official record for NCT05985486 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05985486. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05985486 testing in simple terms?
This study tests if losing weight or changing diet can help prevent or delay Alzheimer's disease in adults with Down syndrome. It is for adults with Down syndrome who do not have dementia and have a BMI between 25 and 50.
Why is this trial significant?
This trial addresses a critical gap in understanding how lifestyle changes like weight loss can impact the risk of Alzheimer's disease, a condition disproportionately affecting adults with Down syndro
What are the potential risks of participating in NCT05985486?
Potential risks include those associated with weight loss, such as fatigue or nutrient deficiencies, and side effects from MRI scans. Some participants may experience discomfort during blood draws or cognitive testing. The weight loss intervention may not be effective for everyone, and there's a risk of regaining weight. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05985486?
Ask your doctor if this study is right for you and what the potential risks and benefits are. You will attend monthly online health education sessions and visit the study center three times over 12 months for blood draws, cognitive tests, MRI scans, and weight measurements. The weight loss group will follow a reduced-calorie diet using pre-purchased meals and track their progress online. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05985486 signal from an investment perspective?
This trial signals a growing interest in preventative strategies for neurodegenerative diseases in specific populations, potentially opening new markets for lifestyle interventions and related health This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to a weight loss program or a general health education group, involving monthly remote sessions and in-person visits for tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Down Syndrome Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.