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
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.
- Are you between 18 and 55 years old?
- Do you have a diagnosis of schizophrenia?
- Are you currently on a stable dose of a single antipsychotic medicine?
- Are you able to understand and consent to participating in a study?
- Are you not pregnant, breastfeeding, or recently given birth?
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
Locations (16)
- Medical University InnsbruckVerified postcodeInnsbruck, Austria
- UPC KU LeuvenVerified postcodeLeuven, Belgium
- National Institute of Mental HealthVerified postcodeKlecany, Czechia
- Psykiatrisk Center GlostrupVerified postcodeGlostrup Municipality, Denmark
- University of AugsburgVerified postcodeAugsburg, Germany
- University Hospital CologneVerified postcodeCologne, Germany
- Central Institute of Mental HealthVerified postcodeMannheim, Germany
- Ludwig Maximilian UniversityVerified postcodeMünchen, Germany
- Semmelweis UniversityVerified postcodeBudapest, Hungary
- Sheba Medical CenterVerified postcodeRamat Gan, Israel
- University of Campania Luigi VanvitelliVerified postcodeNaples, Italy
- AOU Città della Salute e della Scienza di TorinoVerified postcodeTorino, 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?
Discussion
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