TSPO Modulation in AD
This research is investigating a new drug called XBD173 for people living with Alzheimer's disease. The main goal is to find out if this medicine, taken as a tablet twice a day for 28 days, can improve how well blood flows and provides nutrients to the brain, especially in areas important for memory. This process is known as neurovascular coupling. Researchers will compare those taking the drug with those taking a dummy pill (placebo) to see if there's a real difference. They'll also look at how the drug might affect other aspects of brain health, like blood vessel function and specific markers in the blood. The study aims to understand if XBD173 could be a helpful new treatment option.
At a glance
What is this study about?
This study is looking into a new medication called XBD173, specifically for people with Alzheimer's disease. We know that maintaining good blood flow and support to the brain is really important for its health and function. In Alzheimer's, this process, called neurovascular coupling, can sometimes not work as well as it should. Think of neurovascular coupling as the brain's way of making sure it gets enough fuel (blood) when it's working hard, like when you're trying to remember something.
The main question of this study is whether XBD173 can help improve this crucial blood flow process in the brain for people with Alzheimer's. Participants will take the drug for 28 days, and researchers will use special scans to measure how blood flow changes, especially during memory tasks. They will also look at other important markers related to brain health and different measurements in the blood to understand the full effects of the drug.
This research is still in its earlier stages (Phase 2), meaning it's about seeing if the drug works and is safe enough to move on to larger studies. By understanding how XBD173 might affect brain blood flow, we hope to learn if it could offer a new way to support brain health for people with Alzheimer's disease.
Key takeaways
- This study is testing a new drug for Alzheimer's disease called XBD173.
- It focuses on improving blood flow to the brain, which is vital for memory and brain health.
- Participants will take the drug for 28 days and have regular check-ups, blood tests, and MRI scans.
- Some participants will receive the active drug, while others will receive a dummy pill (placebo).
- Both people with Alzheimer's and healthy volunteers are needed for different parts of the study.
- Your participation could help scientists learn more about new treatments for Alzheimer's.
Who may be eligible?
To be considered for this study, people with Alzheimer's disease generally need to be between 60 and 90 years old. They must have a specialist diagnosis of mild to moderate Alzheimer's and have specific genetic markers and brain scan results that fit the study's requirements. If you're a man, you should be willing to use contraception during the study and for 90 days afterward.
There are also some things that would prevent someone from joining. For example, if you have frequent migraines, certain kidney or liver problems, severe breathing difficulties, or if you can't have an MRI scan. If you've recently changed your Alzheimer's medications or certain blood pressure drugs, or if you're taking specific strong medications that interact with the study drug, you might not be able to participate. The researchers also need to make sure you can safely take part in all study activities and complete the required tests.
Healthy volunteers aged 18 or older are also needed for some parts of the study. They will also need to have certain genetic and brain markers, and women who could become pregnant will need to have a pregnancy test before scans.
- Are you between 60 and 90 years old with a diagnosis of Alzheimer's disease?
- Do you have mild to moderate memory problems?
- Can you have an MRI scan safely and without issues?
- Do you have certain genetic markers (TSPO and APOE) for the study?
- Are you able to visit the clinic for multiple appointments over several weeks?
- Are you not currently on specific medications that might interfere with the study drug?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, the study will involve different stages. The first six participants will start with a 'dose escalation' phase, where some take the drug once a day and others twice a day for 28 days to check safety. For the main part of the study, you would either receive the active drug (XBD173, as a tablet twice a day for 4 weeks) or a dummy pill (placebo).
Throughout the study, you'll have several visits. These will include check-ups to make sure you're safe and well, where doctors will look at any side effects. There will also be a number of 'assessment visits' which involve medical checks, blood tests, and MRI scans of your brain. Healthy volunteers will have fewer visits, typically a screening visit and one MRI scan. The total duration of your involvement will depend on which part of the study you are in.
Potential risks and benefits
Locations (1)
- NIHR Imperial CRFLondon, United Kingdom
Common questions
What is neurovascular coupling?
It's how your brain makes sure it gets enough blood when it's busy, like when you're thinking or trying to remember things.
What is XBD173?
It's an experimental drug being tested to see if it can improve brain blood flow in people with Alzheimer's disease.
Will I definitely get the active drug?
In the main part of the study, participants are randomly given either the active drug or a dummy pill (placebo).
What's an MRI scan for in this study?
MRIs are used to measure blood flow in your brain and check other aspects of brain health without using X-rays.
How long do I need to take the study drug?
Participants will take the study drug (or placebo) for 28 days, which is 4 weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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