AuthorisedTherapeutic use (Phase IV)Interventional

Effect of treatment of the cholinergic precursor Choline Alfoscerate in mild cognitive dysfunction

Patient.info understands that you might be looking for information about clinical trials. This particular study is investigating a medicine called Choline Alfoscerate for people who have mild cognitive dysfunction, which means they might have some problems with their memory or thinking that aren't severe enough to greatly interfere with daily life. The researchers are especially interested in individuals whose memory problems might be linked to damage to their blood vessels. The main aim is to see if this medicine can help slow down or stop certain changes in the brain, like the shrinking of important memory areas. They will use detailed brain scans (MRI) to measure these changes. The study also wants to see if the medicine can improve memory, thinking skills, mood, and motivation.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Universita' Degli Studi Di Camerino

Enrolment target

Start

31 Jan 2025

Mild cognitive dysfunction

What is this study about?

This study is looking into a medication called Choline Alfoscerate, sometimes known by the brand name GLIATILIN. It's being tested in people who have mild cognitive dysfunction. This simply means you might be experiencing some minor changes in your memory, thinking speed, or ability to focus, but these changes aren't serious enough to stop you from doing your daily activities.

The researchers are particularly interested in people whose mild cognitive dysfunction might be connected to damage in the brain's blood vessels. The main goal is to find out if this medicine can help protect the brain and reduce or stop the shrinking of important brain areas, particularly those involved in memory like the hippocampus. They will use special brain scans (MRI) to carefully measure any changes in these brain areas.

Beyond looking at brain structure, the study also aims to understand if Choline Alfoscerate can make a difference in how people think and feel. This includes seeing if it improves memory, problem-solving skills, language abilities, and attention. They will also look at how it might affect a person's mood and motivation. This type of study (Phase IV) usually means the medicine is already approved for other uses, and researchers are now gathering more information about its effects in a new group or for a new purpose.

Key takeaways

The study tests a medicine called Choline Alfoscerate for mild memory problems.
It focuses on memory issues linked to blood vessel damage in the brain.
Brain scans (MRI) will check for changes in brain areas related to memory.
The study also looks at how the medicine affects thinking skills, mood, and motivation.
It's open to adults (any age), both men and women.

Who may be eligible?

To join this study, people of any age can be considered, and it's open to both men and women. The most important thing is that you have mild cognitive dysfunction, meaning some mild memory or thinking problems. Importantly, these problems should be connected to some form of damage to the blood vessels in your brain.

The researchers will need to check your medical history and do some tests to make sure that the study is suitable for you. This often includes looking at your memory and thinking abilities, as well as checking for signs of vascular damage in your brain.

Every study has specific criteria, and while the listed information is brief, it's always best to discuss with the study team if you think you might be a good fit. They can provide a full list of what is and isn't allowed for participants.

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.

Do I have mild memory or thinking problems?
Has my doctor mentioned any signs of blood vessel damage related to my memory?
Am I open to taking a new medication being studied?
Am I able to have regular brain scans (MRI)?
Am I willing to have my memory and thinking assessed regularly?

Answer every question to see your result.

What does participation involve?

In this study, you would be taking medication called GLIATILIN, which contains the active ingredient Choline Alfoscerate. We don't have details on the exact number of visits or the total length of the study here, but typically, studies like this involve regular check-ups at a clinic over several months or even longer. You would likely have a starting visit where your current memory and thinking skills are assessed, and you'd receive your medication. During the study, clinic visits would involve further assessments, including memory tests to see if your thinking abilities improve or stay steady. You would also have repeat brain scans using MRI to monitor any changes in the brain's structure. These scans are like detailed photographs of your brain. The study team will explain everything fully, including how often you'd need to visit and for how long.

Potential risks and benefits

Taking part in a study like this might have potential benefits, such as contributing to medical knowledge about mild memory problems and potentially experiencing an improvement or stabilisation in your own cognitive abilities. However, there are also potential risks; for example, the medicine might not work, or you might experience side effects, although these are not listed here. You will always have the right 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
Italy

Common questions

What is 'mild cognitive dysfunction'?

It means you have some minor problems with your memory or thinking, but they're not severe enough to stop you from going about your daily life.

What is Choline Alfoscerate?

It's a medication that researchers hope might help protect brain cells and improve thinking abilities, especially in people with memory issues linked to blood vessel problems.

What does a 'brain scan (MRI)' involve?

An MRI is a completely safe and painless scan that uses magnets and radio waves to create detailed pictures of your brain, helping doctors see its structure and any changes.

Will I know if the medicine is working for me?

The study will track your memory and thinking over time. The research team will discuss your progress and the overall study findings with you, often at your regular appointments.

What does 'vascular damage' mean for my brain?

It refers to problems with the blood vessels in your brain, which might affect blood flow and lead to mild memory or thinking issues.