AuthorisedTherapeutic exploratory (Phase II)Interventional

BBB-PET; Evaluation of [18F]MC225 to measure P-glycoprotein function in neurodegenerative disease

This study, called BBB-PET, aims to understand how a vital protective shield in our brains, known as the blood-brain barrier, functions in people with conditions like Alzheimer's disease, a specific type of brain bleed called cerebral amyloid angiopathy, and Parkinson's disease. The blood-brain barrier helps control what gets into and out of the brain. Researchers are using a special brain scan, a PET scan, with a new tracing agent called [18F]MC225. This agent helps them see how well the barrier is working and if it's letting substances pass through as it should. The goal is to find better ways to measure this function, which could lead to improved understanding and treatment of these neurodegenerative diseases. It's an early-stage study, meaning it's exploring new methods.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

02 Dec 2024

Alzheimers Disease sporadic Cerebral Amyloid Angiopathy Parkinson

What is this study about?

This research study, called BBB-PET, is exploring how a special protective layer in our brains, known as the blood-brain barrier, works in people with certain brain conditions. Think of the blood-brain barrier like a very strict bouncer that controls what chemicals and harmful substances can enter the brain from the bloodstream. It's crucial for keeping our brains healthy.

Researchers are particularly interested in how this barrier functions in individuals who have Alzheimer's disease, a specific type of brain bleed called cerebral amyloid angiopathy (which is related to amyloid protein build-up), or Parkinson's disease. We know that problems with this barrier might play a role in these conditions. By understanding exactly what is happening at the barrier, scientists hope to learn more about these diseases and potentially develop new ways to diagnose or treat them in the future.

To do this, the study uses a type of advanced brain scan called a PET scan. During the scan, a very small amount of a new, specially designed tracing agent, called [18F]MC225, is given. This tracer helps the doctors see how well the blood-brain barrier is allowing things to pass through. They will also look at how blood flows in the brain using another type of scan. This is an early stage of research, like a detective looking for clues to better understand these complex brain conditions. The findings could be very important for future medical breakthroughs.

Key takeaways

This study explores a protective brain barrier in Alzheimer's, certain brain bleeds, and Parkinson's.
It uses special PET brain scans with a new tracing agent.
The goal is to better understand these brain conditions.
It is an early-stage research study, not a treatment trial.
Participants must be 18 or older with one of the selected conditions.

Who may be eligible?

This study is open to both men and women. You must be at least 18 years old to take part; there is no upper age limit, meaning older adults are welcome too.

Before you can join, the study team will ask you some questions and do some checks to make sure the study is a safe and good fit for you. This helps ensure that the research is accurate and that participants are not put at unnecessary risk.

Generally, you would be considered if you have been diagnosed with Alzheimer's disease, sporadic Cerebral Amyloid Angiopathy (a specific type of brain bleed), or Parkinson's disease. The medical team will review your health history to confirm you meet all the necessary requirements.

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 at least 18 years old?
Do you have a diagnosis of Alzheimer's disease?
Do you have a diagnosis of sporadic Cerebral Amyloid Angiopathy (a specific type of brain bleed)?
Do you have a diagnosis of Parkinson's disease?
Are you comfortable with undergoing brain scans, including PET and MRI?
Are you comfortable with having blood samples taken from a vein?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits to the study centre. These visits will involve undergoing special brain scans. Primarily, you'll have a PET scan after receiving a small amount of the tracing agent, [18F]MC225. You will also likely have an MRI scan, which helps to look at the brain's structure and how blood flows. Instead of taking blood samples from an artery, which can be uncomfortable, the study plans to take blood samples from a vein (like a standard blood test) to check how the tracer is moving through your body.

These tests are designed to measure how the protective blood-brain barrier in your brain is working. The study does not involve taking new medications as part of the research itself, but rather uses these special scans to gather information. The total duration of your participation will involve these scan appointments and any follow-up needed.

Potential risks and benefits

Taking part in an early-stage study like this might not directly benefit you, but the information gained could help others in the future by improving our understanding of brain diseases. Potential risks include discomfort from the injections for the tracers, and exposure to a very small amount of radiation from the PET scans, which is generally considered safe. There might also be unknown risks, as this is a new tracing agent. You are always 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.

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Unverified
Netherlands

Common questions

What is the blood-brain barrier?

It's a protective shield in your brain that controls what substances can get in and out, keeping your brain safe from harmful chemicals.

What is a PET scan?

A PET scan is a special type of brain scan that uses a small amount of a tracer to show how your brain is working at a cellular level.

Will I have to take any new medicines?

No, this study does not involve taking new medications. It focuses on using special scans and tracers to gather information about your brain.

Is the tracing agent safe?

The tracing agent [18F]MC225 is new, but it is used in carefully controlled amounts approved for research. The study team will explain any known risks.

How long will I be in the study?

The study involves several appointments for scans and tests. The study team will provide a detailed schedule if you are interested in participating.