A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia

Inclusion Criteria:

• Men or post-menopausal women between 50 and 85 years
• Clinical diagnosis of vascular dementia according to NINDS-AIREN criteria
• CT or MRI results compatible with clinical diagnosis
• MMSE score between 10 and 24, both inclusive
• Modified Hachinski Ischemic Score >4
• Hamilton Depression Scale score of less than or equal to 15
• Adequate visual and auditory acuity to allow neuropsychological testing
• Informed consent given by the patient and/or the next-of-kin

Exclusion Criteria:

• Gastric ulcer associated with intolerance of acetylsalicylic acid treatment
• Severe psychotic features, schizophrenia, depression, agitation or behavioral problemswithin the last three months that could lead to difficulty complying with the protocol
• Any severe systemic illness or unstable medical condition that could lead todifficulty complying with the protocol or significantly limits life span.
• Patients who in the investigator's opinion, would not comply with study procedures
• Any significant neurological disease other than vascular dementia, such as Parkinson'sdisease, epilepsy, Huntington's disease, normal pressure hydrocephalus, brain tumor,progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiplesclerosis
• History of alcohol or substance abuse or dependence within the past two years
• Patients with a history of systemic cancer within the past two years
• Severe congestive heart failure or malignant, uncontrollable hypertension
• Participation in a clinical trial with an investigational drug in the past four weeks