Cognitive function after liver transplantation comparing Tacrolimus formulations
This study is for people who have had a liver transplant and are taking a medicine called tacrolimus. We want to understand if different versions of this medicine have different effects on how well people think, pay attention, and remember things. This is important because feeling sharp and having good memory can really improve your daily life. We will compare two forms of tacrolimus: Prograf and Envarsus. Participants will be asked about their concentration and memory, and a series of simple tests will be used to check their thinking skills. The study also looks at overall quality of life and any side effects to help doctors choose the best medicine for future patients.
At a glance
What is this study about?
This study is all about understanding how different forms of a medicine called tacrolimus might affect people who have had a liver transplant. Tacrolimus is a really important medicine that helps stop your body from rejecting the new liver. However, some people wonder if it can affect their thinking skills, like how well they pay attention, concentrate, or remember things. This study aims to find out if there are differences between the two main versions of this medicine – Prograf and Envarsus – in how they impact these mental abilities.
The main goal is to see if your own feelings about your attention and memory improve over six months after taking one of these medicines. We'll ask you to fill out a questionnaire where you tell us how you feel about your concentration and memory. But it's not just about what you feel; we'll also use some simple computer games and puzzles to check your thinking skills in a more formal way. These tests look at things like how quickly you can switch between tasks, how well you can remember numbers, and how fast you can identify patterns.
Ultimately, this research helps doctors make better choices about which tacrolimus medicine might be best for their patients after a liver transplant, not just for the liver itself, but also for ensuring they have the best possible quality of life, including sharp thinking and good memory. It's about combining the medical need with how you feel every day.
Key takeaways
- This study explores how tacrolimus affects thinking and memory after a liver transplant.
- It compares two forms of tacrolimus: Prograf and Envarsus.
- Participants will complete questionnaires and simple mental tests.
- The study lasts about 12 months with a few visits.
- It's for adults who have had a liver transplant and are already taking tacrolimus.
- The goal is to improve patient care and quality of life after a liver transplant.
Who may be eligible?
This study is looking for adults who have had a liver transplant. You need to be at least 18 years old to take part, and there's no upper age limit. Both men and women are welcome to join.
Specifically, you should already be taking one of the tacrolimus medications mentioned in the study (either Prograf or Envarsus) as part of your regular care after your liver transplant. The study is designed to compare how these existing medications affect people, rather than starting new medications.
If you're unsure if you fit these descriptions, it's always best to chat with your doctor or the study team. They can help you understand all the requirements and decide if this study is a good fit for you.
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 had a liver transplant?
- Are you currently taking tacrolimus medication (Prograf or Envarsus)?
- Are you able to attend study visits over approximately 12 months?
What does participation involve?
If you decide to take part, you'll have a few visits to the clinic over a period of about 12 months. At the start (called 'Screening'), you'll be asked about your health and a close relative or partner might be asked about your daily executive function. You'll also complete questionnaires about your attention, memory, and general quality of life, and do some simple thinking tests.
Throughout the study, you'll continue to take your prescribed tacrolimus medication (either Prograf or Envarsus) as usual. Your regular doctor will oversee your general health and medication. There will be further visits at 6 months and 12 months where you'll repeat the questionnaires and thinking tests. At each visit after the first one, the study team will also keep a close eye on any side effects, important blood test results, and how your liver and kidneys are working.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is tacrolimus?
Tacrolimus is a medicine often given after an organ transplant, like a liver transplant, to help stop your body from rejecting the new organ.
What are 'cognitive functions'?
Cognitive functions are your brain's abilities, like how well you pay attention, remember things, solve problems, and think clearly.
Will I have to stop my current medication?
No, you will continue to take your tacrolimus medication as prescribed by your doctor. This study compares how different versions of this medicine affect people who are already using them.
What is a 'Phase IV' study?
A Phase IV study means the medicine is already approved and being used by patients. This phase helps us learn more about its long-term effects and how it performs in real-world use.
How long will I be in the study?
You will participate in the study for about 12 months, with a few visits over that time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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