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Study on Lithium Carbonate for Patients with TBR1-Related Neurocognitive Disorder

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What is this study about?

This clinical trial is focused on studying a condition known as TBR1-related neurocognitive disorder. This disorder is linked to changes in the TBR1 gene, which can affect brain function and development. The study will explore the effects of a treatment using lithium carbonate, a medication commonly used to treat mood disorders. In this trial, lithium carbonate will be administered in the form of capsules or tablets.

The purpose of the study is to evaluate how 24 months of treatment with lithium carbonate can impact the behavior and quality of life of individuals with TBR1-related neurocognitive disorder. Participants will first undergo an observation period lasting between 6 to 12 months. Following this, they will receive lithium carbonate treatment for 24 months. During this time, researchers will monitor changes in adaptive behavior, which refers to how well a person can adjust to their environment and daily life activities.

Throughout the study, participants will be assessed at various intervals to track improvements in socialization, communication, and overall quality of life. The study will also look at any side effects related to lithium carbonate and changes in brain activity. This research aims to provide valuable insights into the potential benefits and safety of using lithium carbonate for individuals with TBR1-related neurocognitive disorder.

1 observational period

The trial begins with an observational period lasting between 6 to 12 months. During this time, no medication is administered. The purpose is to establish a baseline for your adaptive behavior, which will be measured using the Vineland II Adaptive Behaviour Scale (VABS-II).

2 start of treatment

After the observational period, you will begin treatment with lithium carbonate. This medication is taken orally, either in capsule or tablet form. The specific dosage and frequency will be determined by the study team based on your individual needs.

3 treatment duration

The treatment with lithium carbonate will continue for 24 months. During this time, your adaptive behavior will be regularly assessed to monitor any changes or improvements.

4 regular assessments

Throughout the 24-month treatment period, you will undergo regular assessments. These assessments will include evaluations of your socialization and communication skills, quality of life, and any changes in behavior. The assessments will occur at 6, 12, 18, and 24 months.

5 monitoring for side effects

During the trial, you will be monitored for any side effects related to the lithium carbonate treatment. The severity and frequency of any adverse events will be recorded and managed by the study team.

6 end of treatment

At the end of the 24-month treatment period, a final assessment will be conducted to evaluate the overall impact of the lithium carbonate on your adaptive behavior and other measured outcomes.

Who Can Join the Study?

  • Written informed consent from the patient, parent, or legal representative. This means you or your guardian must agree in writing to participate in the study.
  • Must be 6 years old or older at the time of giving consent.
  • Must have a proven pathogenic or probably pathogenic TBR1 variant. This is a specific change in the TBR1 gene confirmed by special tests.
  • If you are taking any psychoactive medication (medicines that affect your mind), the dose and schedule must be stable for at least 2 months before starting lithium treatment.
  • Must be able to take tablets or capsules by mouth.
  • If you are a female of childbearing age, you must use a highly effective method of contraception (like certain birth control pills or devices) during the treatment and for at least 3 months after the last dose of lithium.
  • Must have one available parent or guardian who can attend all visits and has acceptable reading skills.
  • If you are a male of childbearing age, you must use a highly effective method of contraception (like a condom) during the treatment and for at least 5 days after the last dose of lithium.

Who Cannot Join the Study?

  • Patients who do not have a proven or probably pathogenic variant of the TBR1 gene cannot participate. This means that if you do not have a specific change in the TBR1 gene that is known or likely to cause disease, you cannot join the study.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups, so if you are not in one of these groups, you cannot join.
  • Patients who are not part of the specified clinical trial group cannot participate. This means that if you do not belong to the group of people the study is focusing on, you cannot join.
  • Patients who are not male or female cannot participate. The study is open to both males and females, so if you do not identify as either, you cannot join.
  • Patients who are not considered part of a vulnerable population cannot participate. This means that if you are not part of a group that is considered to need special protection, you cannot join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Hospital Femme Mere Enfant Bron France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Cgwznj Hupajrytila Uvdynclhowihi De Doupc Dijon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.01.2025

Trial locations

Investigated drugs:

Lithium Carbonate is a medication used in this clinical trial to help manage symptoms in patients with TBR1-related neurocognitive disorder. It is commonly used to treat mood disorders, such as bipolar disorder, by stabilizing mood swings. In this study, the goal is to see if taking lithium carbonate for 24 months can improve adaptive behavior, which means helping patients better manage daily activities and interactions. The trial will observe patients for 6 to 12 months before starting the lithium carbonate treatment to understand its effects better.

Investigated diseases:

TBR1-related neurocognitive disorder – This disorder is associated with genetic variants in the TBR1 gene, which plays a crucial role in brain development. It is characterized by a range of neurodevelopmental issues, including intellectual disability and difficulties in communication and socialization. The progression of the disorder can vary, but it often involves challenges in adaptive behavior, which refers to the ability to adjust to new situations and to learn new skills. Individuals may also experience behavioral issues and, in some cases, seizures. The disorder is considered rare, and its symptoms can manifest in early childhood, continuing to affect development as the individual grows. The severity and specific symptoms can differ widely among those affected.

Trial ID:
2024-513955-34-00
Protocol code:
ESALIT
NCT ID:
NCT06776848
Trial Phase:
Human Pharmacology (Phase I) – Other

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