Cerebril™ in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy


Phase 2 Results

Eligibility Criteria

Inclusion Criteria
- Patients must be 55 years of age or older.
- Males and females. Females must be of non-childbearing potential (i.e. surgically sterilized or at least one year post-menopausal).
- Diagnosis of possible or probable CAA based on the Boston Criteria for Diagnosis of CAA-Related Hemorrhage.
- Nonfatal lobar hemorrhage (defined as hemorrhage in the cerebral cortex and underlying white matter sparing the basal ganglia and thalamus) within previous five years diagnosed by CT or MRI scan.
- Patient has no intent to donate blood for 4 weeks after completion of the study.
- Signed informed consent.
Exclusion Criteria
- Other established causes of hemorrhage at the time of the index hemorrhage event. Exclusion causes include excessive anticoagulation (INR > 4.0), associated head trauma or ischemic stroke, CNS tumor, vascular malformation, vasculitis, and blood dyscrasia.
- Patient with a clinically significant and uncontrolled cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, hematological condition or other significant medical disease.
- Presence of any condition that could interfere with the interpretation of study results or compromise patient safety.
- Debilitated neurological state or other known disease likely to result in early death.
- Disability characterized by a modified Rankin score ≥ 4.
- ALT, ALP, AST or total bilirubin ≥ 1.5 the upper limit of normal ranges.
- Contraindications to MRI scan (e.g. cranial metallic implant, cardiac pacemaker, and severe claustrophobia).
- Allergy and/or hypersensitivity to analgesic agents used for the lumbar puncture (for patients undergoing lumbar puncture only).
- Allergy and/or hypersensitivity to any component of the study medication.
- Use of an investigational drug within 30 days prior to Screening visit.
- Use of warfarin or warfarin containing compounds and heparin or heparin containing compounds within 7 days prior to Baseline (Week 0) visit.
- Diagnosis of cystatin C amyloid angiopathy.
- Active alcohol and/or drug abuse.
- Inability to provide legal consent