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Study on Bumetanide for Improving Cognitive Function in Children and Adolescents with Down Syndrome

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Down syndrome, a genetic condition that affects cognitive functions, which are the mental processes involved in gaining knowledge and understanding. The study will use a medication called Bumetanide, which is a type of diuretic, or water pill, commonly used to help the body get rid of excess fluid. The trial will also include a placebo group for comparison.

The purpose of the study is to explore whether Bumetanide can improve cognitive functions in children and adolescents with Down syndrome. Participants in the study will take the medication or placebo for a period of three months. During this time, researchers will assess changes in cognitive abilities and other related aspects, such as memory and behavior, to determine the effectiveness of the treatment.

The study aims to provide insights into whether Bumetanide can be a beneficial treatment for improving cognitive functions in young individuals with Down syndrome. The trial is designed to be safe, as Bumetanide has been used in humans before with minimal side effects. The results could potentially lead to new treatment options for enhancing the quality of life for those affected by this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study is designed for children and adolescents aged 10 to 17 years with Down syndrome. Participation requires a confirmed diagnosis of Down syndrome through genetic testing.
The mental age of participants should be between 4.5 and 8.5 years, as assessed by a specific test called Leiter-3. This assessment can be done at the first visit or within six months prior to it.
Informed consent must be obtained from both the child and their parents before participation.
Step 2
Treatment phase
Participants will receive either Bumetanide or a placebo. Bumetanide is a medication taken orally in the form of a 1 mg tablet.
The treatment will last for three months. The aim is to assess the potential of Bumetanide to improve cognitive functions and related psychological aspects in participants with Down syndrome.
Step 3
Evaluation of cognitive improvement
The primary goal is to measure improvement in a specific cognitive test called the Visual-Object learning test. A 22% increase in the mean total score after three months of treatment is considered significant.
Secondary evaluations will include other memory tasks, executive function measures, and assessments of psychological well-being, adaptability, and quality of life.
Step 4
Completion of the study
The study is expected to conclude by December 30, 2025. Participants will have completed the treatment and evaluation phases by this time.

Who can join the trial?

4 criteria

The patient must have **Down Syndrome**, which is a genetic condition caused by having an extra copy of chromosome 21.
The patient must be between the ages of 10 and 17 years old.
The patient must have a **mental age** between 4.5 and 8.5 years. Mental age is a measure of a person's intellectual development compared to the average for their actual age.
The patient and their parents must provide **informed consent**, which means they agree to participate in the study after understanding all the details and potential risks.

Who cannot join the trial?

5 criteria

Individuals who do not have Down Syndrome cannot participate. Down Syndrome is a genetic condition that affects a person's development.
Children and adolescents who are not between the ages of 10 and 16 years are excluded.
Participants who cannot take the medication Bumetanide are excluded. Bumetanide is a type of medicine that helps remove extra fluid from the body.
Individuals who have medical conditions that might interfere with the study or the effects of the medication are excluded.
Participants who are unable to follow the study procedures or attend the required visits are excluded.

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Verified sites

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Verified
Ospedale Pediatrico Bambino Gesu'
Rome, Italy

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Investigated drugs

Bumetanide is a medication being studied for its potential to improve cognitive functions in children and adolescents with Down syndrome. It has been used in the past with minimal side effects and is taken orally. The study aims to see if Bumetanide can help with cognitive improvements and related psychological aspects in young individuals with Down syndrome.

BUMETANIDE

What is already known about the treatment

Bumetanide – Bumetanide is administered orally and is currently being studied for its potential to improve cognitive functions in children and adolescents with Down syndrome. It is a well-known medication with a history of use in humans, primarily as a diuretic. The main therapeutic indication being explored in this trial is cognitive enhancement in Down syndrome. At the molecular level, Bumetanide works by inhibiting the Na-K-Cl cotransporter in the kidney, which reduces fluid retention, but its cognitive effects are thought to be related to altering neurotransmitter balance in the brain. It is classified pharmacologically as a loop diuretic.

Investigated diseases

Down Syndrome – Down Syndrome is a genetic disorder caused by the presence of an extra chromosome 21. This condition leads to developmental and intellectual delays, which can vary in severity among individuals. People with Down Syndrome often have distinct facial features, such as a flat facial profile and an upward slant to the eyes. They may also experience a range of health issues, including heart defects and thyroid problems. The condition affects cognitive abilities, leading to challenges in learning and memory. Social and emotional development can also be impacted, requiring supportive environments to help individuals reach their full potential.