BridgeMD
A double-blinded, randomized, placebo-controlled, multi-center trial of Efgartigimod in autoimmune dementia (EfgaDem)
EU CTIS ID: 2023-510216-39-00
What this study is testing
To investigate the efficacy of 52 weeks treatment with the FcRn inhibitor Efgartigimod in comparison to placebo regarding the cognitive impairment in patients with autoimmune dementia.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female subjects ≥ 40 years of age
- Expert diagnosis of progressive cognitive impairment or dementia for more than 3 months
- 10 < MoCA ≤ 25
- Presence of anti-brain autoantibodies in serum and/or CSF
- Age ≥ 40 years
- Speaks German at a level that, as determined by the investigator, allows to understand the patient information and to reliably perform the neuropsychological assessments
You likely can't join if
- Dysfunction (other than neurodegenerative or immunological) that could distort or obscure the diagnosis of dementia such as vitamin deficiency or hypothyroidism
- HIV infection
- Active, severe infections (e.g. sepsis and opportunistic infections)
- History of chronically active hepatitis including active or chronic hepatitis B, acute or chronic hepatitis C
- Clinically significant infection involving intravenous administration of antibiotics and hospitalization in the 4 weeks prior to the screening visit
- Serious impairment of the immune system
See the full eligibility criteria
- Male and female subjects ≥ 40 years of age
- Expert diagnosis of progressive cognitive impairment or dementia for more than 3 months
- 10 < MoCA ≤ 25
- Presence of anti-brain autoantibodies in serum and/or CSF
- Age ≥ 40 years
- Speaks German at a level that, as determined by the investigator, allows to understand the patient information and to reliably perform the neuropsychological assessments
- Written consent to participate in the study
- The patient is capable to attend study visits
- Vaccination according to STIKO recommendations (incl. COVID-19 vaccination)
- Dysfunction (other than neurodegenerative or immunological) that could distort or obscure the diagnosis of dementia such as vitamin deficiency or hypothyroidism
- HIV infection
- Active, severe infections (e.g. sepsis and opportunistic infections)
- History of chronically active hepatitis including active or chronic hepatitis B, acute or chronic hepatitis C
- Clinically significant infection involving intravenous administration of antibiotics and hospitalization in the 4 weeks prior to the screening visit
- Serious impairment of the immune system
- Severe disease in the renal, cardiovascular or hematological system
- Any medical condition that, in the opinion of the Investigator, might interfere with the patient’s participation in the trial or poses any added risk for the patient
- Severe active psychiatric illness
- Contraindications against MRI examination (e.g. wearers of pacemakers, deep brain stimulators, cerebrospinal fluid shunt valves, very large tattoos, metal splinter injuries and implants containing metal in the body)
- Participation in any other investigational drug study or exposure to an investigational drug within 5 half-lives of the study drug at baseline
- MRI findings (macro bleeding, malignant tumors)
- Treatment with B-cell depleting therapy in the last 6 months
- History of recurrent or chronic infections or with underlying diseases which may further predispose patients to serious infection
- Sexually active male and female patients of reproductive potential (female patients/female partners of patients less than 12 months postmenopausal) who do not use highly effective contraception methods (pearl index <1) during treatment
- Hypersensitivity to the active substance and/or pharmaceutical excipients
- Known cytokine release syndrome after infusions
- Pregnancy or lactation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.