NCT00947531

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

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Ever Neuro Pharma GmbH · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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 \[intravenous\] 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.

Conditions

• Vascular Dementia

Interventions

Type	Name	Description
DRUG	Cerebrolysin
DRUG	0.9% Saline Solution

Timeline

• Start date: 2006-10-01
• Completion: 2007-08-01
• First posted: 2009-07-28
• Last updated: 2024-02-21
• Results posted: 2009-07-28

Locations

21 sites across 1 country: Russia