Status:
COMPLETED
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
Lead Sponsor:
Ever Neuro Pharma GmbH
Collaborating Sponsors:
acromion GmbH
Geny Research Corp.
Conditions:
Vascular Dementia
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
This clinical trial was performed to assess the clinical efficacy and safety of two 4 week treatment courses of daily intravenous administration of Cerebrolysin (20mL \[milliliter\] IV \[intravenous\]...
Eligibility Criteria
Inclusion
- 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
- Gastric ulcer associated with intolerance of acetylsalicylic acid treatment
- Severe psychotic features, schizophrenia, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol
- Any severe systemic illness or unstable medical condition that could lead to difficulty 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's disease, epilepsy, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00947531
Start Date
October 1 2006
End Date
August 1 2007
Last Update
February 21 2024
Active Locations (21)
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1
Chita State Medical Academy/Regional Psychiatric Hospital No. 2
Chita, Russia
2
Chita State Medical Academy/Veterans Hospital
Chita, Russia
3
Irkutsk State Institute of Postgraduate Education/Regional Clinical Hospital
Irkutsk, Russia
4
Kazan State Medical University/Municipal Clinical Hospital No. 6
Kazan', Russia