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

Ever Neuro Pharma

Status and phase

Completed

Phase 4

Conditions

Vascular Dementia

Treatments

Drug: 0.9% Saline Solution

Drug: Cerebrolysin

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00947531

EBE-RU-051201

Details and patient eligibility

About

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] per day). The study was performed as prospective, randomised, double-blind, placebo-controlled, parallel group, multicentre study with 2 study groups.

Group 1: 20 mL Cerebrolysin and 100 mg (milligram) acetylsalicylic acid Group 2: Placebo (0.9% NaCl [sodium chloride]) and 100 mg acetylsalicylic acid The study drug was given once daily by intravenous infusion (20ml in 250ml saline solution) for 4 weeks on five consecutive days per week. This treatment regimen was repeated after a two-month treatment-free interval. Acetylsalicylic acid was given orally, once daily throughout the study duration of 24 weeks.

Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24 were necessary.

Enrollment

242 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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 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