Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

SAD and MAD study of VES001

This research study, called the SAD and MAD study, is investigating a new potential medicine named VES001. It's specifically for people with a type of dementia known as Frontotemporal Dementia, or FTD. This is a very early stage of research, meaning it's the first time this medicine is being tested in humans. The main goal at this point is to see if VES001 is safe and how the body handles it. They will also look at how it moves through the body and if it has any effects. This kind of study is crucial for understanding whether a new medicine could eventually be used to help treat FTD. Participants will be carefully monitored, and the study will provide important information for future research into this condition.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Insusense ApS, Insusense ApS

Enrolment target

Start

11 Oct 2023

Frontotemporal dementia (FTD)

What is this study about?

This study is a very important first step in understanding a new medicine called VES001, which could potentially help people living with Frontotemporal Dementia (FTD). FTD is a type of dementia that often affects people at a younger age than other types, changing their personality, behaviour, and language. Currently, there aren't many treatments for FTD, so finding new ways to help is really important.

Because this is the first time VES001 is being given to people, the main aim is to check its safety. Researchers want to see if there are any side effects and how much of the medicine the body can handle without problems. They will also learn how the medicine behaves inside the body, such as how long it stays there and how it's processed.

Even though this is an early study and not directly looking at treating FTD symptoms yet, the information gathered is absolutely vital. It helps scientists decide if VES001 is safe enough to move to bigger studies in the future, where they would then look at whether it can actually improve symptoms of FTD. This is how all new medicines are developed.

Key takeaways

This is an early study of a new medicine (VES001) for Frontotemporal Dementia (FTD).
It's the first time this medicine is being given to people to check its safety.
The study aims to understand how the medicine works in the body.
Participation helps scientists learn about FTD and develop future treatments.
You must be 18 or older to join, and both men and women are welcome.

Who may be eligible?

This study is looking for volunteers who are adults, meaning they must be 18 years old or older. There is no upper age limit mentioned.

Both men and women are welcome to take part in this research. The study needs a diverse group of people to understand how the new medicine works across different individuals.

To see if you're a good fit, the study doctors and nurses will have a chat with you and carry out some health checks. They will carefully explain everything you need to know about the study and answer any questions you have.

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?
Are you a man or a woman?
Do you have a diagnosis of Frontotemporal Dementia?
Are you able to attend appointments regularly?
Are you willing to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic or hospital over a specific period. During these visits, you might have blood tests, heart rhythm checks (ECGs), and other assessments to monitor your health and how your body is responding to the medicine. You would be given the study medicine, VES001, under careful medical supervision.

There would also be follow-up appointments after you've stopped taking the medicine to make sure you're still feeling well and to collect any final information. The total length of your involvement in the study, including all visits and follow-ups, would be explained to you in detail by the research team before you make any decisions.

Potential risks and benefits

While we hope that studies like this will lead to new treatments, it's important to know that early-stage studies like this one are mainly about safety, so there might not be any direct health benefits for you personally. However, taking part in research helps us learn more about Frontotemporal Dementia and could help others in the future. As with any medicine, there's always a chance of side effects, which the medical team will explain fully. You are always free to stop taking part in 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
Netherlands

Common questions

What is Frontotemporal Dementia (FTD)?

FTD is a type of dementia that mainly affects parts of the brain responsible for behaviour, personality, and language, often starting at a younger age than other dementias.

What does 'Phase I' study mean?

Phase I means it's the very first time a new medicine is being tested in people. The main goal is to check its safety and how the body handles it.

Will this medicine cure my FTD?

This early study isn't designed to cure FTD or improve symptoms directly. It's about checking safety and how the medicine works in the body to see if it's safe for future research.

Do I have to pay to join the study?

No, you will not have to pay to take part in the study. All study-related care and medicine will be provided free of charge.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your medical care.