Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

EVALUATION OF THE EFFICACY OF TOLCAPONE AS A GENOTYPE-BASED TARGETED COGNITIVE ENHANCER IN SCHIZOPHRENIA, BASED ON THE POLYMORPHISM RS4680

This research trial is investigating a medication called Tasmar (tolcapone) in people with schizophrenia. The main goal is to see if Tasmar can help improve 'thinking skills,' also known as cognitive function, such as memory, attention, and problem-solving. This is especially important for people with a particular genetic marker called rs4680, as the study aims to understand if the medicine works differently for them. Researchers will use special brain scans (fMRI) to look at brain activity and compare test scores on thinking tasks to see how effective Tasmar is. They will also collect information on general well-being and symptom changes to get a full picture of the treatment's effects. Participants must be 18 years or older, and both men and women can join.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Clinica Universidad De Navarra

Enrolment target

Start

14 May 2024

SCHIZOPHRENIA

What is this study about?

This research study is set up to explore a new way of treating some of the challenges faced by people with schizophrenia, specifically focusing on their thinking abilities. Schizophrenia can sometimes make it harder to concentrate, remember things, or solve problems. This study is testing a medicine called Tasmar (which contains a drug called tolcapone) to see if it can help improve these skills.

The interesting part of this study is that it's looking at how Tasmar might work differently for people based on their genes. Everyone has a unique genetic makeup, and sometimes a tiny difference in a gene can affect how a medicine works in your body. In this case, the researchers are particularly interested in a genetic change called rs4680. By focusing on people with this specific genetic marker, they hope to learn if Tasmar is more effective for them, leading to more tailored treatments in the future.

To understand how well Tasmar works, the researchers will use various methods. They'll ask participants to do specific computer-based tests that measure things like memory, attention, and how quickly they react. They will also use a special type of brain scan called fMRI. This scan allows doctors to see which parts of the brain are active when someone is performing a task, helping them understand if Tasmar changes how the brain works. Additionally, the study will collect information on general symptoms, mood, and quality of life to get a complete picture of the medicine's effects.

Key takeaways

This study investigates if a drug called Tasmar can improve thinking skills in people with schizophrenia.
It's particularly focused on how genetics (rs4680 marker) might influence the medicine's effects.
Researchers will use thinking tests and brain scans (fMRI) to measure outcomes.
Participants must be 18 years or older, and all genders are welcome.
The study aims to find more personalized treatments for schizophrenia.

Who may be eligible?

To be able to join this study, participants must be at least 18 years old. There is no upper age limit mentioned, meaning older adults may also be able to take part.

Both men and women are welcome to participate in this research, as the study is open to all genders.

However, it's important to remember that these are just the basic requirements. There will be other specific health checks and criteria that a doctor will need to discuss with you to make sure the study is a good fit and safe for you. For instance, the study specifically looks at individuals with schizophrenia and a certain genetic marker (rs4680), so you would need to meet these detailed medical conditions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with schizophrenia?
Are you willing to take a study medication (Tasmar tablets)?
Are you comfortable with cognitive tests and potentially brain scans (fMRI)?
Have you discussed your overall health with the study team?
Do you know if you have the rs4680 genetic marker (this might be tested during screening)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the medication Tasmar as film-coated tablets. The dose would be 100 mg. You would have regular visits to the clinic where tests will be carried out to check your thinking skills. These include computer-based tasks like the DPX cognitive test and other tasks from the MATRICS battery, which measure things like memory and attention. The researchers will also use special brain scans called fMRI to look at your brain activity. You can expect to complete questionnaires about your mood and general well-being. Throughout the study, doctors will also assess your medical condition using standard clinical scales. The exact number of visits, the total duration of the study, and how often you'd need follow-up appointments would be explained in full detail by the study team.

Potential risks and benefits

Participating in a study like this might offer the potential benefit of trying a new treatment that could improve your thinking skills and overall well-being. However, like all medicines, Tasmar can have side effects, and some tests, like fMRI scans, might involve small inconveniences. The study team will explain all known potential risks in detail before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is 'cognition' and why is it important?

Cognition refers to your thinking skills, like memory, paying attention, and problem-solving. Improving these can really help with daily life.

What is Tasmar (tolcapone) and how is it given?

Tasmar is a medicine being tested in this study. It is given as a 100 mg tablet that you swallow.

What is a 'genetic marker' like rs4680?

A genetic marker is a small difference in your DNA. Researchers are looking at rs4680 because it might affect how Tasmar works for you.

What is an fMRI scan?

An fMRI is a special type of brain scan that shows which parts of your brain are active when you're thinking or doing certain tasks.

Will I know if I'm getting the active drug or a placebo?

Clinical trials are often 'blinded,' meaning you might not know if you're receiving the study drug or a dummy pill (placebo) until later. This is to ensure fair results. The study team will explain.