AuthorisedTherapeutic exploratory (Phase II)Interventional

Influence of Dexmedetomidine on the Human Glymphatic Cerebrospinal Fluid Flow, Neural Activity and Cerebral Blood Flow in Functional Magnetic Resonance Imaging (GlymphDex)

This study, called 'GlymphDex,' is trying to understand how a special medicine named Dexdor affects your brain. We're looking at things like how active your brain is, how blood flows through it, and how fluid (called cerebrospinal fluid) moves within your brain. We're particularly interested in how these things change when you are more or less awake or alert. This research is important for conditions where the brain doesn't work as it should, such as neurodegenerative diseases like dementia, or problems like delirium (a state of confusion) and other acute brain illnesses. This is an early phase (Phase II) study, meaning we're exploring how this medicine works on the body.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Helsinki University Central Hospital

Enrolment target

Start

25 Sep 2023

Neurodegenerative disease Delirium Acute neurological disease

What is this study about?

Imagine your brain has a special cleaning system, like a plumbing network, that helps clear out waste. This system involves fluid moving through your brain. This study, called GlymphDex, is trying to understand how a medicine named Dexdor affects this important fluid movement, as well as brain activity and blood flow. We're using special brain scans called Functional Magnetic Resonance Imaging (fMRI) to see these changes.

We want to learn how Dexdor influences these brain processes when people's state of consciousness changes – for example, when they are more awake or when they are lightly sedated. This is really important because problems with fluid movement and brain activity are linked to serious conditions like dementia and other brain illnesses, including confusion (delirium) that can happen after surgery or due to other illnesses.

The main goal is to see how brain signals, especially those related to activity, pulse, blood flow, and fluid movement, change with different levels of awareness while on Dexdor. We'll also look at how these changes relate to sleep quality, other body measurements, and even certain substances in your blood. This research helps us build a better picture of how our brains work and how medicines might help people with specific brain conditions.

Key takeaways

This study investigates how Dexdor medicine affects brain function and fluid movement.
It uses special brain scans (fMRI) to understand changes in brain activity and blood flow.
The research aims to help people with conditions like dementia, delirium, and other brain illnesses.
Participants will receive Dexdor and undergo brain scans and blood tests.
You must be 18 or over and have certain brain conditions to be eligible.
Your participation could help advance understanding of brain health.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Beyond these basic requirements, the specific health conditions you have will be very important. For example, the study is focused on people who have certain neurodegenerative diseases (conditions affecting the brain over time, like some forms of dementia), delirium (a state of sudden confusion), or acute neurological diseases (sudden brain conditions).

However, there will be other important health checks to make sure the study is safe and appropriate for you. A study doctor will review your full medical history and conduct examinations to determine if you are a good fit for this research.

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 18 years old or older?
Do you have a diagnosis of a neurodegenerative disease (e.g., certain types of dementia)?
Have you recently experienced delirium or an acute neurological illness?
Are you comfortable having an MRI scan?
Are you able to attend multiple study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be receiving the study medicine, Dexdor, which is given as an infusion (through a drip). You would undergo several brain scans using a machine called an fMRI. These scans help us see what's happening inside your brain, including its activity, blood flow, and fluid movement. We will also monitor your brain waves using equipment similar to an ECG for your heart, but for your brain (this is called an EEG).

Throughout the study, we will take blood samples to measure different factors and see how they are affected by the medicine. We'll also keep track of your general body functions, like heart rate and breathing. The study will involve multiple visits for these assessments, and the full duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as contributing to medical knowledge that could help future patients with similar conditions. You might also receive careful monitoring of your health during the study. However, there are also potential risks, as with any medicine. Dexdor can have side effects, which will be fully explained before you agree to participate. The procedures, such as blood tests and MRI scans, also carry very small risks. Your safety is very important, and you will be closely monitored. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Finland

Common questions

What is Dexdor?

Dexdor is a medicine given through a drip that can help calm you and change your level of awareness, which doctors sometimes call 'sedation'.

What is fMRI?

fMRI is a special type of brain scan that shows doctors which parts of your brain are active and how blood is flowing there.

Why are you studying brain fluid?

Your brain has a cleaning system involving fluid. Researchers believe understanding how this fluid moves can help us learn more about brain conditions like dementia.

Will I feel different during the study?

Because a medicine that affects your awareness is being used, you might feel more relaxed or drowsy at times. The study team will monitor you closely.

Is this a new medicine?

Dexdor is already used in some medical settings. This study is exploring how it specifically affects brain processes and fluid movement in specific conditions.