Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study on Efgartigimod for Patients with Autoimmune Dementia

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as autoimmune dementia. This is a type of dementia where the body's immune system mistakenly attacks healthy brain cells, leading to problems with memory and thinking. The trial will test a treatment called Efgartigimod, which is given as a solution for injection. Efgartigimod is designed to help reduce the immune system's attack on the brain by blocking a specific protein involved in this process.

The purpose of the study is to see how effective Efgartigimod is over a period of 52 weeks in improving cognitive function, which includes memory and thinking skills, in people with autoimmune dementia. Participants in the study will receive either Efgartigimod or a placebo, which looks like the treatment but does not contain the active substance. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will have regular check-ups to monitor changes in their cognitive abilities and overall quality of life. These assessments will take place at various points, including at the start of the study and then at weeks 13, 27, and 53. The study will also look at changes in certain markers in the blood and cerebrospinal fluid, which is the fluid surrounding the brain and spinal cord, to better understand how the treatment is working. The trial aims to provide valuable insights into the potential benefits of Efgartigimod for people with autoimmune dementia.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age and medical history.

    A series of assessments are conducted, including cognitive tests and blood tests, to establish a baseline for your health and cognitive function.

  2. Step 2

    Treatment phase

    The treatment phase lasts for 52 weeks. During this time, you will receive either the study medication, efgartigimod alfa, or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin.

    The dosage is 1,000 mg per injection. The frequency of administration will be explained during the initial visit.

  3. Step 3

    Regular assessments

    Throughout the trial, regular assessments are conducted to monitor your health and the effects of the treatment. These assessments occur at weeks 13, 27, and 53.

    The assessments include cognitive tests, quality of life evaluations, and blood tests to measure changes in autoantibodies and other laboratory parameters.

  4. Step 4

    Final evaluation

    At the end of the 52-week treatment period, a final evaluation is conducted. This includes a comprehensive review of your cognitive function and overall health.

    The results from this evaluation are compared to the initial baseline to determine the impact of the treatment.

Who can join the trial?

8 criteria

  • Male and female participants who are 40 years of age or older.
  • Have an expert diagnosis of progressive cognitive impairment or dementia for more than 3 months. This means a doctor has confirmed that your memory and thinking skills are getting worse.
  • Score between 10 and 25 on the MoCA test. The MoCA test is a simple test that checks your memory and thinking skills.
  • Have anti-brain autoantibodies in your blood or spinal fluid. These are special proteins that can affect your brain.
  • Speak German well enough to understand the study information and complete the memory and thinking tests.
  • Provide written consent to participate in the study. This means you agree in writing to join the study.
  • Be able to attend study visits. This means you can travel to the place where the study is happening.
  • Have received vaccinations according to STIKO recommendations, including the COVID-19 vaccination. This means you have had the recommended shots to protect against diseases.

Who cannot join the trial?

7 criteria

  • Patients with any other **autoimmune disease** that affects the brain, besides autoimmune dementia, cannot participate. An autoimmune disease is when the body's defense system attacks its own cells.
  • Patients who have had a **serious infection** in the past month cannot participate. A serious infection is an illness caused by germs that can make you very sick.
  • Patients who are currently receiving treatment with another **experimental drug** cannot participate. An experimental drug is a medicine that is still being tested and is not yet approved for general use.
  • Patients with a history of **severe allergic reactions** to any medication cannot participate. A severe allergic reaction is a strong and dangerous response by the body to a substance.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of **substance abuse** in the past year cannot participate. Substance abuse is the harmful use of substances like drugs or alcohol.
  • Patients with any other **serious medical condition** that might interfere with the study cannot participate. A serious medical condition is a health problem that requires ongoing treatment and can affect daily life.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Efgartigimod is a medication being studied for its potential to help people with autoimmune dementia. This condition affects the brain and can lead to problems with memory and thinking. Efgartigimod works by blocking a specific protein in the body called FcRn. This protein is involved in the immune system, and by blocking it, Efgartigimod may help reduce the harmful immune response that is thought to contribute to the symptoms of autoimmune dementia. The goal of using Efgartigimod in this trial is to see if it can improve cognitive function, which includes memory, attention, and problem-solving skills, in patients over a period of 52 weeks.

What is already known about the treatment

Efgartigimod – Efgartigimod is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its potential use in treating autoimmune dementia, a condition where the immune system mistakenly attacks the brain, leading to cognitive decline. The main therapeutic indication for Efgartigimod is to improve cognitive function in patients with this type of dementia. At the molecular level, Efgartigimod works by inhibiting a protein called FcRn, which plays a role in regulating the immune system's activity. By blocking this protein, Efgartigimod aims to reduce the harmful immune response that contributes to the symptoms of autoimmune dementia. It is classified pharmacologically as an FcRn inhibitor.

Investigated diseases

Autoimmune Dementia – Autoimmune dementia is a condition where the body's immune system mistakenly attacks healthy brain cells, leading to cognitive decline. This disease is characterized by memory loss, confusion, and difficulties with thinking and problem-solving. As the condition progresses, individuals may experience changes in behavior and personality, as well as difficulties with language and communication. The progression of symptoms can vary, with some individuals experiencing a rapid decline, while others may have a more gradual onset. The disease can affect daily functioning, making it challenging for individuals to perform routine tasks. Over time, the accumulation of cognitive impairments can significantly impact the quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510216-39-00Protocol codeEfgartAID01Estimated enrolment69 patientsSponsorDeutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.