AuthorisedTherapeutic exploratory (Phase II)Interventional

A double-blinded, randomized, placebo-controlled, multi-center trial of Efgartigimod in autoimmune dementia (EfgaDem)

This research study, called EfgaDem, is investigating a new medicine named Vyvgart for people living with autoimmune dementia. Autoimmune dementia is a condition where the body's immune system mistakenly attacks the brain, affecting memory and thinking. This study aims to see if Vyvgart can improve these cognitive symptoms over approximately 53 weeks (about a year), compared to a placebo (a dummy drug with no active medicine). Participants will receive either Vyvgart or the placebo by injection. Researchers will regularly check memory, thinking, quality of life, and daily activities to understand how well the medicine works and if it's safe. It's a key step in finding better treatments for this condition.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.

Enrolment target

Start

17 Jun 2025

Autoimmune dementia

What is this study about?

This research study, known as EfgaDem, is focusing on a condition called autoimmune dementia. This is a type of dementia where your body's immune system, which normally fights off infections, starts to attack healthy brain cells by mistake. This can lead to problems with memory, thinking, and daily activities. The main goal of this study is to see if a new medicine, called Vyvgart, can help improve these symptoms.

Researchers want to understand if Vyvgart can make a difference in how people's memory and thinking abilities change over about a year. They'll be comparing the effects of Vyvgart to a 'dummy' treatment, called a placebo, which looks just like the real medicine but contains no active drug. This comparison helps them work out if any improvements are genuinely due to the medicine or something else. They'll also be looking at how the medicine affects things like quality of life and the ability to do everyday tasks.

The study is called a 'Phase II' trial. This means it's one of the earlier stages of testing new medicines. It's designed to gather more information about how safe the medicine is and if it shows promise in treating the condition before it can be tested on a much larger group of people. If successful, it could lead to a new treatment option for people with autoimmune dementia.

Key takeaways

The study tests a new medicine, Vyvgart, for autoimmune dementia.
It aims to improve memory and thinking over about a year.
Participants will receive either Vyvgart or a dummy treatment (placebo).
Regular health checks and memory tests will be part of the study.
This is an early-stage study to understand effectiveness and safety.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. The study welcomes both men and women.

The most important requirement is that you have a diagnosis of autoimmune dementia. This means your doctors have determined that your dementia is caused by your immune system attacking your brain.

There might be other specific health conditions or medications that would prevent you from joining, but these will be discussed in detail by the study team. They will also carry out checks to make sure the study is a safe and suitable option for you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with autoimmune dementia?
Are you comfortable with regular clinic visits and health assessments?
Are you able to receive injections as part of the treatment?

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, you'll receive either the study medicine, Vyvgart, or a placebo (a dummy treatment) through injections. Neither you nor your doctor will know which one you're receiving – this is to make sure the results are as fair as possible. These injections will be given regularly over approximately 53 weeks (just over a year).

Throughout the study, you'll have several visits to the clinic. At these visits, doctors and nurses will check your health, ask about your memory, thinking, and how you're managing daily activities. You'll likely do tests to measure your cognitive abilities, and the study team will also take blood and possibly other samples to understand how your body is responding to the treatment. There will be regular follow-up appointments to monitor your progress and safety. The total duration of your active participation in the study will be about 53 weeks.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as gaining access to a new medicine that isn't yet widely available, and closely monitored medical care. However, there's no guarantee the medicine will improve your condition, and you might receive a placebo. As with any medicine, there could be potential risks or side effects from the injections or the study drug itself. All known risks will be explained to you before you agree to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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Germany

Common questions

What is autoimmune dementia?

It's a type of dementia where your body's immune system mistakenly attacks your brain, causing problems with memory and thinking.

What is Vyvgart?

Vyvgart is the medicine being tested in this study. It's a new treatment that may help with autoimmune conditions.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps researchers compare the effects fairly.

How long will the study last?

If you join, your active participation in the study will last for about 53 weeks, which is just over a year.

Will I know if I'm getting the real medicine?

No, neither you nor your doctor will know if you're receiving Vyvgart or the placebo. This is to ensure fair and accurate results.