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Not yet recruitingPHASE3INTERVENTIONAL

A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia

Schizophrenia can affect thinking and memory, which current medicines don't always help with. This study is exploring a new medicine called Xanomeline/Trospium (XT) to see if it can improve these cognitive challenges over a full year. XT works differently from existing treatments by targeting specific brain systems and has shown promise in earlier trials for reducing other schizophrenia symptoms. This 12-month study will be the first to deeply investigate XT's effects on thinking skills, memory, and concentration. Researchers also want to understand how these improvements might connect to a person's overall daily life, symptom control, and quality of life. The aim is to find better ways to help people with schizophrenia live more fully.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
European Group for Research In Schizophrenia
Enrolment target
171
Start
01 Jan 2027
Estimated completion
01 Jul 2029

What is this study about?

Schizophrenia is a serious and long-lasting mental health condition that affects around 1 in 100 people. It can cause a range of symptoms, including seeing or hearing things that aren't there (hallucinations) and having strong false beliefs (delusions). While current medicines, called antipsychotics, are good at helping with these symptoms, they often don't do much for other common problems, like difficulties with memory, concentration, and planning – often called 'cognitive' symptoms. These cognitive challenges can make it hard for people to go to work, study, or manage daily life.

This study is looking at a new medicine called Xanomeline/Trospium (XT), which works in a different way to existing treatments. XT targets a specific chemical system in the brain to help with symptoms, while trying to limit unwanted side effects in other parts of the body. XT has already been approved in 2024 for treating other symptoms of schizophrenia because it has been shown to be effective and generally safe in earlier studies. However, researchers now want to take a much closer look at its potential benefits for thinking and memory skills.

Most studies on schizophrenia medicines haven't focused enough on long-term changes in thinking and memory. This new study is important because it will be the first to thoroughly examine these cognitive effects over a whole year of treatment with XT. It will also explore how any changes in thinking skills relate to other important aspects of life, such as how well symptoms are controlled, how easily someone can manage daily tasks, and their overall quality of life. The results could help doctors and patients choose treatments that not only control common symptoms but also significantly improve thinking and memory, ultimately supporting a better recovery and daily life.

Key takeaways

  • This study evaluates a new schizophrenia medicine, XT, for improving thinking and memory.
  • XT is already approved for other schizophrenia symptoms.
  • The study lasts one year and involves regular check-ups and assessments.
  • It aims to understand how XT affects daily life and overall well-being.
  • Participants will switch from their current medicine to XT.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 55 years old and have a confirmed diagnosis of schizophrenia. You should be able to understand what the study involves and agree to take part. You also need to be on a stable dose of a single antipsychotic medicine for at least four weeks before the study starts.

There are also some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or have given birth recently. You also can't participate if you are at a serious risk of harming yourself, currently experiencing a manic episode or severe depression, or have a severe problem with alcohol or drugs. The study will also screen for certain substances in your system.

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.

  1. Are you between 18 and 55 years old?
  2. Do you have a diagnosis of schizophrenia?
  3. Are you currently on a stable dose of a single antipsychotic medicine?
  4. Are you able to understand and consent to participating in a study?
  5. Are you not pregnant, breastfeeding, or recently given birth?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for about one year, plus a follow-up period of 4 weeks after your treatment ends. You would begin by signing a consent form and having some checks to see if you're suitable. Once you officially start, you'll receive the new medicine, Xanomeline/Trospium (XT), and gradually stop taking your current antipsychotic medicine over two weeks. You will visit the study clinic several times throughout the year for assessments of your general well-being and safety. Some of these visits will include repeating initial measurements. In between some visits, there will also be phone calls to check on your mental health, any side effects, and other medications you might be taking. Everyone in the study will receive the XT medicine.

Potential risks and benefits

Taking part in this study could potentially improve your thinking, memory, and overall daily functioning by using a new treatment for schizophrenia. As with any medication, there's a possibility of side effects, though earlier studies suggest XT is generally well-tolerated. The research team will closely monitor your health and any side effects throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

  • Medical University Innsbruck
    Verified postcode
    Innsbruck, Austria
  • UPC KU Leuven
    Verified postcode
    Leuven, Belgium
  • National Institute of Mental Health
    Verified postcode
    Klecany, Czechia
  • Psykiatrisk Center Glostrup
    Verified postcode
    Glostrup Municipality, Denmark
  • University of Augsburg
    Verified postcode
    Augsburg, Germany
  • University Hospital Cologne
    Verified postcode
    Cologne, Germany
  • Central Institute of Mental Health
    Verified postcode
    Mannheim, Germany
  • Ludwig Maximilian University
    Verified postcode
    München, Germany
  • Semmelweis University
    Verified postcode
    Budapest, Hungary
  • Sheba Medical Center
    Verified postcode
    Ramat Gan, Israel
  • University of Campania Luigi Vanvitelli
    Verified postcode
    Naples, Italy
  • AOU Città della Salute e della Scienza di Torino
    Verified postcode
    Torino, Italy

Common questions

What is Cognitive Impairment?

Cognitive impairment refers to difficulties with thinking skills like memory, attention, planning, and problem-solving. These can sometimes be affected in schizophrenia.

What is Xanomeline/Trospium (XT)?

XT is a new medicine for schizophrenia that works differently from many existing treatments. It has been approved for treating other schizophrenia symptoms and is now being studied specifically for its effects on thinking and memory.

Will I have to stop my current medicine if I join?

Yes, if you join, you will gradually stop taking your current antipsychotic medicine over about two weeks as you start the new XT medicine.

How long does the study last?

The treatment part of the study lasts for one year, with a follow-up check-in about a month after your treatment finishes.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Inge Winter, Dr.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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