RecruitingOBSERVATIONAL

Amyloid-β Clearance Mechanisms in Alzheimer's Disease

This study aims to understand how the brain clears a specific protein called amyloid-beta (Aβ). This protein is known to build up in the brains of people with Alzheimer's disease. Researchers are using advanced brain imaging, specifically PET scans, to investigate several ways the brain might get rid of this protein. They are looking at the blood-brain barrier (a protective shield around the brain), the glymphatic system (the brain's own waste removal system), and how enzymes break down Aβ. The study also wants to see if there's a link between sleep and how well the brain clears these proteins. Participants will include people with early memory problems or mild Alzheimer's, and the goal is to create a better model of how Aβ is removed from the brain.

At a glance

Status

Recruiting

Sponsor

Ludwig-Maximilians - University of Munich

Enrolment target

Start

01 Jun 2021

Estimated completion

01 Oct 2025

Alzheimer's Disease (AD)

What is this study about?

This research is looking into how the brain cleans itself, specifically focusing on a protein called amyloid-beta (Aβ). In Alzheimer's disease, this protein can build up and form clumps, which scientists believe play a key role in the condition. Understanding how the body normally removes Aβ is really important, as it could help discover new ways to prevent or treat Alzheimer's.

The study will use special brain scans, called PET scans, to get a detailed look at what's happening inside the brains of volunteers. They're especially interested in several key areas. Firstly, they want to understand the 'blood-brain barrier', which is like a protective wall that controls what goes in and out of the brain. They think changes in this barrier might affect how Aβ builds up. Secondly, they're investigating newer ideas about the brain's own clean-up crew, called the glymphatic and lymphatic systems, which act like a waste disposal network for brain cells. They want to see how these systems contribute to removing Aβ.

Ultimately, the researchers hope to build a clearer picture of how all these different systems work together to get rid of amyloid-beta. They will also explore if sleep plays a role in how well these cleaning systems function. By studying people with very early memory changes or mild Alzheimer's, they aim to get closer to understanding the disease and potentially finding new approaches to tackling it.

Key takeaways

This study aims to understand how the brain cleans a protein linked to Alzheimer's.
It uses special brain scans to look at how different body systems remove this protein.
Participants include people with early memory problems or mild Alzheimer's.
We are not testing new medicines, but gathering important research information.
Your contribution could help scientists develop better treatments for the future.

Who may be eligible?

To be able to join this study, you would need to have either early memory issues (called Mild Cognitive Impairment), mild Alzheimer's disease, or be someone who has noticed memory changes but doesn't have a formal diagnosis yet. You also need to be able to understand the study and agree to take part in writing, and your current medications should have been stable for at least 4 days before any tests. You would also need to speak German fluently.

There are several reasons why you might not be able to join. For example, if you have other serious mental health conditions like schizophrenia or severe depression, or if you've had a recent severe head injury. People with certain serious medical conditions, such as severe heart, lung, or kidney problems, or those with electronic implants like a pacemaker, wouldn't be able to take part. If you are pregnant or have had cancer recently, you would also likely not be able to join.

Ultimately, the study doctors will review your full medical history to make sure that taking part is safe and appropriate for you.

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 50 and 85 years old?
Have you been diagnosed with Mild Cognitive Impairment, mild Alzheimer's disease, or noticed memory changes?
Can you understand and give written permission to join the study?
Have your usual medications been stable for at least 4 days?
Do you speak German fluently?
Do you have any electronic implants (like a pacemaker)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a number of assessments. This will include detailed medical checks, memory and thinking tests, and special brain scans like MRI and PET scans. You might also have a spinal fluid test (CSF) and wear a device to track your activity, possibly related to sleep patterns.

All these assessments will happen during a single period of time – there won't be any follow-up appointments planned as part of this specific project. The purpose is to gather a lot of information at one point in time. The researchers will not be giving you any new medication, nor will they be asking you to change your current prescribed treatments, as long as they have been stable for at least four days before your study assessments.

Potential risks and benefits

Taking part in research studies always comes with potential benefits and risks. For you, a potential benefit could be a very thorough health check-up, including detailed brain scans, which could give you and your doctor extra information about your health. While this study is not designed to improve your health directly, the information gathered is vital for helping scientists better understand Alzheimer's disease, which could lead to better treatments for others in the future. Potential risks could include discomfort from blood tests or the spinal fluid test, and exposure to a small amount of radiation from the PET scan. There are also risks associated with MRI scans for people with certain medical conditions or implants. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
Verified postcode
München, Germany· Recruiting

Common questions

What is amyloid-beta?

Amyloid-beta is a protein found naturally in the brain. In Alzheimer's disease, it can clump together and form 'plaques', which are thought to harm brain cells.

What is a PET scan?

A PET scan is a special type of brain scan that uses a safe, mildly radioactive substance to show how your brain is working and if certain proteins are building up.

What is the blood-brain barrier?

It's like a protective filter around your brain that controls what substances can enter from your bloodstream, helping to keep your brain healthy.

Will I receive new medication in this study?

No, this study is about understanding how the brain works, not about testing new medications. You will continue with your usual treatments.

Will my information be kept private?

Yes, any information collected about you during the study will be kept confidential and anonymised to protect your privacy.

How to find out more

Robert Perneczky, Prof.Dr.med.

psy.alzheimerzentrum@med.uni-muenchen.de +4989440055863 Official trial record

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