CERebrolysin In CADASIL (NCT05755997) | Clinical Trial Compass
Active — Not RecruitingPhase 2
CERebrolysin In CADASIL
Czechia30 participantsStarted 2023-11-29
Plain-language summary
The objective of this trial is the global risk-benefit assessment of Cerebrolysin as compared to Placebo in patients with genetically proven CADASIL. In addition, a traditional approach will be taken based on an evaluation of the separate risk and benefit domains in comparison with placebo.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Patient participates voluntarily and gave written informed consent
Exclusion criteria
✕. Any significant neurological disease/conditions other than CADASIL
✕. Focal lesions that may be responsible for the cognitive status of the patient (e.g.
✕. Any other diseases/conditions that may affect compliance with the protocol, such as:
✕. severe psychiatric disorders within the last three months
✕. delusional symptoms
✕. history of schizophrenia, schizoaffective disorder, bipolar affective disorder
✕. major depressive disorder newly identified within eight weeks before screening