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Cerebrolysin in CADASIL
EU CTIS ID: 2024-513828-42-00
What this study is testing
The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared to Placebo in patients with genetically proven CADASIL.
- 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
- Patients of ≥18 years of age, all genders
- Diagnosis of CADASIL based on clinical symptoms, MRI, and genetic analysis
- MoCA >11
- Adequate visual, auditory, and language skills (no language interpreter required) to follow study procedures
- Patient is not of childbearing potential (i.e. women are post-menopausal for two years, surgically sterile, or using adequate method of contraception such as hormonal contraception in combination with a barrier method, the use of an intrauterine device or hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence)
- Patient participates voluntarily and gave written informed consent
You likely can't join if
- Any significant neurological disease/conditions other than CADASIL
- Focal lesions that may be responsible for the cognitive status of the patient (e.g. infectious disease, space-occupying lesion, normal pressure hydrocephalus)
- Any other diseases/conditions that may affect compliance with the protocol, such as: a. severe psychiatric disorders within the last three months b. delusional symptoms c. history of schizophrenia, schizoaffective disorder, bipolar affective disorder d. major depressive disorder newly identified within eight weeks before screening e. history of alcohol or substance abuse or dependence within the past two years
- Any circumstances that -in the investigator’s opinion- may result in the patient’s non-compliance with study procedures, e.g. fragile or thin veins that prevent many i.v. infusions
- Any other disease/conditions that may affect the safety assessment, such as: a. history of systemic cancer within the past two years b. history of myocardial infarction in the past year or unstable or severe cardiovascular disease (including uncontrolled hypertension and/or history of unstable hypertension not compensated by antihypertensive therapy) c. any clinically significant laboratory abnormalities at screening d. uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (HbA1c >87 mmol/mol)
- Use of concomitant medication with neuroprotective/neurotrophic/nootropic effects (e.g. ginkgo biloba, erythropoietin, citicoline, amantadine, piracetam)
See the full eligibility criteria
Who can join
- Patients of ≥18 years of age, all genders
- Diagnosis of CADASIL based on clinical symptoms, MRI, and genetic analysis
- MoCA >11
- Adequate visual, auditory, and language skills (no language interpreter required) to follow study procedures
- Patient is not of childbearing potential (i.e. women are post-menopausal for two years, surgically sterile, or using adequate method of contraception such as hormonal contraception in combination with a barrier method, the use of an intrauterine device or hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence)
- Patient participates voluntarily and gave written informed consent
What rules you out
- Any significant neurological disease/conditions other than CADASIL
- Focal lesions that may be responsible for the cognitive status of the patient (e.g. infectious disease, space-occupying lesion, normal pressure hydrocephalus)
- Any other diseases/conditions that may affect compliance with the protocol, such as: a. severe psychiatric disorders within the last three months b. delusional symptoms c. history of schizophrenia, schizoaffective disorder, bipolar affective disorder d. major depressive disorder newly identified within eight weeks before screening e. history of alcohol or substance abuse or dependence within the past two years
- Any circumstances that -in the investigator’s opinion- may result in the patient’s non-compliance with study procedures, e.g. fragile or thin veins that prevent many i.v. infusions
- Any other disease/conditions that may affect the safety assessment, such as: a. history of systemic cancer within the past two years b. history of myocardial infarction in the past year or unstable or severe cardiovascular disease (including uncontrolled hypertension and/or history of unstable hypertension not compensated by antihypertensive therapy) c. any clinically significant laboratory abnormalities at screening d. uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (HbA1c >87 mmol/mol)
- Use of concomitant medication with neuroprotective/neurotrophic/nootropic effects (e.g. ginkgo biloba, erythropoietin, citicoline, amantadine, piracetam)
- Any condition that would represent a contraindication for Cerebrolysin administration: a. hypersensitivity to one of the components of the drug b. epilepsy c. severe renal impairment (estimated Glomerular Filtration Rate [eGFR] <30 ml/min/1.73 m2 as assessed at local laboratory within one month before screening)
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.