Research study for people who have cerebral small vessel disease (cSVD, damaged small blood vessels in the brain) and a stroke, which may lead to impaired memory and thinking and then dementia
This research study aims to find new treatments for people who have had a stroke and also have damaged small blood vessels in their brain. When these tiny vessels are stiff or leaky, it can sometimes lead to problems with memory and thinking, and potentially dementia. We are testing two drugs, cilostazol and isosorbide mononitrate, which are already used for heart conditions. We've seen promising results in a similar type of stroke and now want to see if these drugs are safe and effective for other kinds of stroke. You might be suitable if you're over 50, have had a stroke, and have this small vessel damage. The study involves taking one or both drugs, or no drugs, for six months. We'll then check your memory and thinking over the phone. Your involvement will help us decide if a larger study is needed, potentially leading to new ways to prevent dementia after a stroke.
At a glance
What is this study about?
This research study is looking for better ways to help people who have experienced a stroke. A stroke happens when the blood supply to part of your brain is cut off. Many people who have a stroke also have a condition where the tiny blood vessels in their brain are damaged, making them stiff or leaky. This combination can sometimes lead to difficulties with memory and thinking, and in some cases, can increase the risk of developing dementia.
Currently, there aren't many specific treatments for this problem. This study is testing two existing medications, called cilostazol and isosorbide mononitrate. These drugs are already used safely for certain heart conditions. We've had encouraging early results when testing these drugs in a specific type of stroke and now want to see if they could also help people with other kinds of stroke who also have these damaged brain vessels.
The main goal is to find out if these drugs are safe and if they show enough promise to be studied further in a larger trial. If successful, this research could pave the way for new treatments to protect your memory and thinking and help prevent dementia after a stroke.
Key takeaways
- Aims to prevent memory and thinking problems after stroke in people with damaged brain vessels.
- Testing two existing drugs: cilostazol and isosorbide mononitrate.
- Participants take study medication for 6 months after discharge from hospital.
- Involves phone calls to check on well-being and memory/thinking abilities.
- Results will help plan a larger study for potential new treatments.
Who may be eligible?
This study is looking for volunteers aged 50 or over. You must have recently had a stroke or a 'mini-stroke' (known as a TIA), which means your brain's blood supply was temporarily interrupted. Importantly, brain scans must also show that you have damage to the small blood vessels in your brain.
It's important that your health is stable, and you should be able to manage most daily tasks on your own or with only a little help. We also need to make sure you can safely take the study medications. There are some specific conditions that would prevent you from taking part, such as having certain other brain conditions, or if the drugs aren't suitable 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 aged 50 or over?
- Have you recently had a stroke or TIA (mini-stroke)?
- Do your brain scans show signs of damaged small blood vessels?
- Is your health generally stable?
- Are you able to take medicines by mouth?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of four groups, like flipping a coin. You might receive cilostazol, isosorbide mononitrate, both drugs, or no drugs at all. You will take the assigned medication for six months, starting when you leave the hospital. The dose will gradually increase over the first few weeks, and you’ll receive clear instructions on how and when to take it.
Throughout the study, research staff from the hospital will call you several times (after 1-2 weeks, 3-4 weeks, and at 6 months) to check how you’re doing, if the dose has been increased correctly, and if you’ve had any side effects. After six months, when you finish taking the medication, a trained coordinator will call you to ask some questions about your well-being, do some memory and thinking tests over the phone, and check for any lasting side effects. The study aims to run until May 2028.
Potential risks and benefits
Locations (25)
- Aberdeen Royal InfirmaryApproximateAberdeen, United Kingdom
- Royal United Hospital BathApproximateBath, United Kingdom
- Royal Victoria HospitalApproximateBelfast, United Kingdom
- Good Hope HospitalApproximateSutton Coldfield, United Kingdom
- Southmead HospitalApproximateBristol, United Kingdom
- Fairfield General HospitalApproximateBury, United Kingdom
- Craigavon Area HospitalApproximateCraigavon, United Kingdom
- Royal Derby HospitalApproximateDerby, United Kingdom
- Dorset County HospitalApproximateDorchester, United Kingdom
- Royal Infirmary of Edinburgh at Little FranceCity onlyLothian, United Kingdom
- Northwick Park HospitalUnverifiedHarrow, United Kingdom
- Victoria HospitalUnverifiedKirkcaldy, United Kingdom
Common questions
What is 'small vessel disease'?
It's a condition where the tiny blood vessels in your brain become damaged, which can affect your brain's health.
What is the purpose of this study?
We want to see if two existing drugs can help protect memory and thinking after a stroke in people with damaged brain blood vessels, potentially preventing dementia.
Will I know which treatment I'm getting?
No, you will be randomly assigned to a group, and neither you nor the doctors will know which treatment you are receiving until the study is over. This helps us ensure fair results.
How long will I take the study drugs?
You will take the assigned study medication for six months.
Who is paying for this research?
The Alzheimer's Society (UK) is funding this study.
How to find out more
Philip Bath
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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