RecruitingNAINTERVENTIONAL

Targeting 18kDa Translocator Protein (TSPO) to Improve Brain Endothelial Cell Function in Cerebral Small Vessel Disease

This study is investigating a condition called Cerebral Small Vessel Disease (cSVD), which affects how blood flows in tiny vessels in the brain. In healthy brains, blood flow increases where needed, but in cSVD, this doesn't happen properly. This can be due to damage to the inner lining of these small blood vessels. We are exploring if a drug called XBD173 can help improve the function of these blood vessels and blood flow. This drug targets a specific protein, TSPO. Participants will receive either XBD173 or a dummy pill for four weeks, then switch after a break. We will use brain scans and blood tests to see if the treatment works.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

106

Start

01 Oct 2024

Estimated completion

01 Apr 2028

Cerebral Small Vessel Disease

What is this study about?

Imagine your brain needs extra fuel (blood) when it's working hard, just like a car needs more petrol when accelerating. In a healthy brain, tiny blood vessels quickly bring this extra fuel to the right areas. But in a condition called Cerebral Small Vessel Disease (cSVD), these tiny vessels don't respond as well, meaning parts of the brain might not get enough blood when they need it most.

This study aims to understand if we can improve how these small blood vessels work. The problem often lies in the cells that line the inside of these vessels, called endothelial cells. We're looking at a specific protein called TSPO, which plays a role in these cells. We want to see if a new drug, XBD173, can change how TSPO works with the goal of making these blood vessels function better.

If we can improve how these blood vessels deliver blood, it could potentially help people with cSVD. This research is important because it could lead to new ways to treat cSVD and improve brain health.

Key takeaways

Investigating a new drug, XBD173, for Cerebral Small Vessel Disease (cSVD).
Aims to improve blood flow in tiny brain vessels by targeting a protein called TSPO.
Participants take XBD173 or dummy pill, then switch after a break (crossover study).
Involves brain MRI scans and blood tests to check blood vessel health.
Open to people aged 60-90 with cSVD and mild memory issues.
Healthy volunteers (60-90) also needed for comparison (single visit).

Who may be eligible?

To be considered for this study, you should be between 60 and 90 years old. You must have a diagnosis of Cerebral Small Vessel Disease (cSVD) based on a brain scan and experience mild memory or thinking problems. We will also check your genes to make sure you have a specific genetic make-up (called AA genotype at rs6971) related to the TSPO protein we are studying.

There are several reasons you might not be able to join. These include having a history of a stroke, frequent migraines, or other brain diseases like Alzheimer's. You also wouldn't be able to participate if you have serious kidney or liver disease, severe breathing problems, or if you take certain medications that could interact with the study drug. People with pacemakers or certain metal implants that prevent having an MRI scan also cannot take part.

We are also looking for healthy volunteers, aged 60-90, for comparison. These volunteers will have a single brain scan and will not take the study drug. They will also need to have their genes checked.

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 60 and 90 years old?
Have you been diagnosed with Cerebral Small Vessel Disease (cSVD)?
Do you have mild memory or thinking problems?
Do you have any metal implants or conditions preventing MRI scans?
Do you have serious kidney, liver, or breathing problems?
Are you currently taking any of the specific medications listed in the study information?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be invited to a special research facility at Hammersmith Hospital. This study uses a "double-blind" approach, meaning neither you nor the study team will know if you're receiving the active drug (XBD173) or a dummy pill (placebo) first. It's also a "crossover" study, which means you will receive both treatments at different times.

For four weeks, you'll take either the study drug or the dummy pill twice a day. After this, there will be a six-week break, called a "washout," where you won't take any study medication. Then, you'll switch to the other treatment (the drug if you had the dummy pill first, or vice-versa) for another four weeks. During the study, you'll have regular brain MRI scans and blood tests to check how your endothelial cells are working and how blood is flowing in your brain. For healthy volunteers, participation involves one visit for a single MRI scan and genetic test.

Potential risks and benefits

It's important to remember that this is a research study, and we can't guarantee any direct benefit to you. However, you would be helping us learn more about Cerebral Small Vessel Disease, which could lead to better treatments for others in the future. As with any medication, there could be side effects from XBD173, though the study team will monitor you closely. MRI scans involve magnets and radio waves, generally considered safe, but there are some risks associated with the contrast dye used in some scans. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial Clinical Research Facility
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Cerebral Small Vessel Disease (cSVD)?

It's a condition where the tiny blood vessels in your brain don't work as well as they should, affecting how blood flows and delivers nutrients.

What is XBD173?

XBD173 is the medicine being tested in this study. It's designed to target a protein in brain cells to improve blood vessel function.

What does 'double-blind' mean?

It means neither you nor the doctors will know if you're taking the active drug or a dummy pill at any given time, to keep the study fair.

Will I have to stop other medicines?

Some medications might interact with the study drug. The study team will review your current medicines to see if any need to be paused or avoided.

How long will my involvement in the study last?

Your involvement will include two periods of treatment (4 weeks each), separated by a 6-week break, plus visits for tests and scans. Healthy volunteers have one visit.

How to find out more

David Owen, PhD

d.owen@imperial.ac.uk +442033136195 Official trial record

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