RecruitingPhase IIInterventional

LACunar Intervention trial - Cognition 1

This research, called LACI-Cog1, is investigating two common medications, cilostazol and isosorbide mononitrate, for people experiencing memory and thinking difficulties due to damage in the brain's tiny blood vessels. This condition is known as small vessel disease (SVD) and can lead to issues with how the brain works. Currently, there aren't many effective treatments for SVD-related memory problems. The study will enrol 60 participants aged 50 and over. They will receive either one, both, or neither of the study drugs. Researchers will then monitor their health, thinking skills, and quality of life over 10 weeks to see if the drugs are safe, manageable, and show potential to help. The findings could guide future care for SVD.

At a glance

Status

Recruiting

Phase

Phase II

Enrolment target

Start

01 Feb 2026

Estimated completion

02 Jan 2028

Vascular cognitive impairment in small vessel disease

What is this study about?

Memory and thinking problems can be really tough, and for many people, they are linked to an issue called small vessel disease (SVD). This happens when the tiny blood vessels in the brain don't work as they should. When these vessels are damaged, they can't deliver enough oxygen and nutrients to the brain, which can affect things like memory and how quickly you think. SVD is actually thought to be a cause of a significant number of dementia cases.

At the moment, we don't have good treatments that specifically target these damaged small blood vessels or the memory and thinking problems they cause. This means the brain damage can unfortunately get worse over time. The LACI-Cog1 study is looking into two existing medicines that we believe might help protect these small brain vessels. One drug, cilostazol, is often used in the UK to improve blood flow in people's legs. The other, isosorbide mononitrate, is commonly used to treat chest pain (angina) caused by heart problems.

The main goal of this study is to see if these two drugs, either on their own or together, are safe to use for people with SVD-related memory problems. We also want to find out if they could potentially improve memory and thinking skills. The results of this study are really important because they could help guide doctors in the future on how to treat people with SVD and possibly even prevent dementia from developing.

Key takeaways

The study explores existing drugs for memory issues linked to brain blood vessel damage.
It aims to check if two common drugs are safe and could improve thinking skills.
Participation involves taking a study drug (or no drug) and having check-ups over 10 weeks.
No guaranteed direct benefits, but vital for future treatments.
Optional brain and eye scans are available but not mandatory.
This research is taking place in Edinburgh.

Who may be eligible?

To join this study, you need to be aged 50 or older. You should also be experiencing some memory or thinking problems, which your doctor believes are mainly caused by small vessel disease in your brain. This would have been seen on a brain scan like an MRI or CT scan.

It's important that you are able to understand what the study involves and agree to take part yourself. You'll also need someone, like a family member or close friend, who knows you well enough to provide information about your daily abilities. This person should also be willing to join the study in this role. You also need to be able to speak and understand English well enough to follow the study instructions.

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 50 years old or older?
Do you have memory or thinking problems that a doctor believes are due to small vessel disease?
Do you have a brain scan (MRI or CT) that shows moderate to severe small vessel disease?
Are you able to understand the study and agree to take part yourself?
Do you have a family member or friend who knows you well and is willing to help with the study?
Can you speak and understand English well?

Answer every question to see your result.

What does participation involve?

If you decide to take part and are found to be suitable for the study, you will be randomly chosen to receive one of the study drugs, both drugs, or no study drugs. This is like flipping a coin to make sure the study results are fair. Throughout the study, you will have follow-up appointments, which can be in person or over the phone. These check-ups will happen at 1, 3, 8, and 10 weeks after you start.

During these appointments, the research team will ask you about your general health, how your memory and thinking are doing, your physical abilities, and your quality of life. They will also check your blood pressure. There might also be optional scans (MRI, eye scans) that look at your brain and eye blood vessels, and these involve a special breathing test. The study will last for a total of 10 weeks.

Potential risks and benefits

While there aren't any guaranteed direct benefits to you from taking part, your participation will be incredibly valuable in helping us understand if these drugs could become future treatments for memory and thinking problems caused by small vessel disease. You will also receive advice on how to keep your blood vessels healthy. The study drugs have well-known side effects, and the research team will explain these clearly to you. Previous studies have shown these drugs are generally safe and well-tolerated. Some participants might find filling out questionnaires or having assessments a bit inconvenient, and while the optional scans are safe, some people might find them a little uncomfortable. You can choose not to have these scans and still be part of the study. You are free to withdraw from the study at any time.

Locations (2)

Royal Infirmary of Edinburgh
Approximate
Edinburgh, Scotland
Royal Infirmary of Edinburgh
Unverified
Edinburgh, United Kingdom

Common questions

What is small vessel disease?

It's a condition where tiny blood vessels in your brain get damaged, which can affect how your brain works and lead to memory and thinking problems.

What are these drugs for?

Cilostazol is usually for leg circulation, and isosorbide mononitrate is for chest pain. This study is exploring if they can help brain blood vessels and memory.

How long will I be involved in the study?

The study lasts for 10 weeks, with check-ups at 1, 3, 8, and 10 weeks.

Do I have to have the brain scans?

No, the brain and eye scans are optional. You can still participate in the study even if you choose not to have them.

Where is the study happening?

The study is being run at the Royal Infirmary of Edinburgh in Scotland.

How to find out more

Daniela Jaime Garcia

daniela.jaimegarcia@nhslothian.scot.nhs.uk 0785 615 7228 Official trial record

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