MedTrace Logo

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

NCT00947531 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2024-02-21

Study results available
· View outcomes & findings →

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

DRUG

Cerebrolysin

DRUG

0.9% Saline Solution

Sponsors & Collaborators

  • acromion GmbH

    collaborator INDUSTRY

  • Geny Research Corp.

    collaborator UNKNOWN

  • Ever Neuro Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Philipp Novak, PhD · EBEWE Neuro Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Completion
2007-08-31

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00947531 on ClinicalTrials.gov