Study on Efgartigimod for Patients with Autoimmune Dementia

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.	Bonn	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Kblijfjm dtt Utpkpehjmvbo Mljugxgz Afe	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	14.07.2025

Trial locations

Investigated drugs:

Efgartigimod Alfa

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.

Investigated diseases:

Dementia

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 ID:

2023-510216-39-00

Protocol code:

EfgartAID01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Efgartigimod for Patients with Autoimmune Dementia

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