RecruitingOBSERVATIONAL

Molecular Imaging of Inflammation in Parkinson's Disease Using LPS and TSPO-PET/MR

This study aims to understand why some people with Parkinson's disease experience increased inflammation and how this affects their symptoms. While the exact cause of Parkinson's is unknown, past research suggests inflammation could be important. Researchers will use special brain scans called PET/MR, which can show areas of inflammation. These scans will be done before and after giving a mild substance called Lipopolysaccharide (LPS), which is known to cause a small amount of inflammation. They will also take blood samples to measure inflammation levels. The goal is to learn more about the disease mechanisms and potentially find new ways to help people living with Parkinson's.

At a glance

Status

Recruiting

Sponsor

University of Exeter

Enrolment target

Start

28 Feb 2022

Estimated completion

31 Aug 2026

Neurodegenerative Diseases Parkinson Disease REM Sleep Behavior Disorder (iRBD)

What is this study about?

Parkinson's disease is a condition that affects the brain, causing problems with movement, balance, and sometimes thinking. We still don't fully understand what causes it or why it gets worse over time. However, recent scientific studies have suggested that inflammation in the brain might play a part in this process. Inflammation is your body's natural response to injury or infection, but sometimes it can happen when it's not needed, potentially causing harm.

This study wants to learn more about how inflammation works in Parkinson's disease. The researchers will use a special type of brain scan called a PET/MR scan. This scan uses a small amount of a safe substance called [11C]PBR28, which acts like a special dye to highlight areas of inflammation in your brain. You will have two of these scans: one before, and one after, receiving a very small, controlled amount of a substance called Lipopolysaccharide (LPS). LPS is known to cause a mild inflammatory response, similar to how your body might react to a minor infection. This will help doctors see how your brain responds to inflammation.

Alongside the brain scans, the study will also take a couple of blood samples. These samples will help the researchers measure different markers of inflammation circulating in your body. By combining all this information, the study hopes to get a clearer picture of how inflammation increases in Parkinson's disease and what mechanisms are involved. Understanding these details could be an important step towards developing new treatments in the future.

Key takeaways

Understanding brain inflammation in Parkinson's.
Using special PET/MR scans to see inflammation.
Comparing brain responses before and after a mild inflammatory trigger (LPS).
No new treatments are being tested, focus is on research.
Participation involves two visits (Exeter and London) over multiple days.
Aims to improve future understanding and potential treatments for Parkinson's.

Who may be eligible?

This study is looking for healthy volunteers between 50 and 85 years old. To be considered, you should not have any significant brain or mental health conditions, and you shouldn't have a history of inflammatory or autoimmune diseases.

Your eyesight and hearing need to be good enough to complete some mental tests. You also shouldn't have a family history of brain conditions that get worse over time. The study will check your understanding and memory to make sure you are in good brain health. If you are a woman who could become pregnant, you'll need to use very effective birth control during the study and for at least six months after the PET scan. Similarly, men with partners who could become pregnant will need to use effective birth control during the study and for three months after each PET scan.

Quick self-check

Are you between 50 and 85 years old?
Do you have good eyesight and hearing?
Do you have good general brain health, memory, and understanding?
Do you have no history of significant brain/mental health issues or inflammatory diseases?
If you are a woman of childbearing potential, are you committed to using highly effective birth control for the study duration and 6 months after the scan?
If you are a man with a partner of childbearing potential, are you committed to using highly effective birth control for the study duration and 3 months after each scan?

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 two main visits. The first visit takes place in Exeter and will last about 3 hours. During this visit, a doctor will explain everything carefully and answer your questions. If you agree, you'll sign a consent form. Then, the doctor will ask about your health, do a physical check-up, and ask you to fill out some questionnaires about your movement, thinking, memory, and mood. You'll also have blood and urine tests. Women who could become pregnant will have a pregnancy test before the scans. Finally, you'll have an MRI scan of your brain, which takes pictures to check its structure and make sure there are no other unexpected findings.

The second visit will take place over two consecutive days in West London. On the first day, you'll have a check-up to see if your medication has changed or if you've had any side effects. You'll also answer some specific questionnaires if you have Parkinson's. If you have Parkinson's disease, and more than 60 days have passed since your last visit (not fully specified in the provided text, but implies a continued process).

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to our understanding of Parkinson's disease, which could help develop future treatments. There are some potential risks, such as the mild inflammatory response from the LPS, and exposure to a small amount of radiation from the PET scans. The blood draws also carry a minimal risk of bruising or discomfort. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Exeter
Exeter, United Kingdom· Recruiting

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain, causing problems with movement like shaking, stiffness, and difficulty with balance and coordination. It can also affect memory and mood.

What is inflammation, and why is it important in this study?

Inflammation is your body's natural way of protecting itself from harm, like infections or injuries. In this study, researchers want to see if too much or the wrong kind of inflammation in the brain might play a role in Parkinson's disease and how it develops.

What is a PET/MR scan?

A PET/MR scan is a special type of imaging that combines two different scans to get very detailed pictures of your brain. It helps doctors see how your brain is working and identify areas where there might be inflammation.

What is Lipopolysaccharide (LPS)?

LPS is a substance that causes a very mild, temporary inflammatory response in your body. It's used in this study to safely trigger a small amount of inflammation so researchers can observe how your brain reacts.

Will I receive any treatment for Parkinson's in this study?

No, this is a study to understand the disease better, not to test a new treatment for Parkinson's disease. You will continue to receive your usual medical care.

How to find out more

Edoardo R. de Natale, MD MSc Ph.D

e.de-natale@exeter.ac.uk 07503741242 Official trial record

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