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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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] 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.


Detailed Summary:
Sponsor: Ever Neuro Pharma GmbH

Current Primary Outcome:

  • Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24 [ Time Frame: baseline and week 24 ]
  • CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 [ Time Frame: week 24 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry, Urinalysis ), ECG (Electrocardiogram) [ Time Frame: Baseline, week 4, 12, 16, 24 ]
  • Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart) [ Time Frame: week 4, 12, 16 ]
  • ADAS-COG+ Response [ Time Frame: week 4, 12, 16, 24 ]
  • Change From Baseline for Original ADAS-COG [ Time Frame: week 4, 12, 16, 24 ]
  • CIBIC+ Sscore [ Time Frame: week 4, 12, 16 ]
  • CIBIC+ Response [ Time Frame: week 4, 12, 16, 24 ]
  • CIBIS+ (Clinicians Interview-Based Impression of Severity) [ Time Frame: week 24 ]
  • Change From Baseline in MMSE (Mini-Mental State Examination) Score [ Time Frame: week 4, 12, 16, 24 ]
  • Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale) [ Time Frame: week 4, 12, 16, 24 ]
  • Change From Baseline in Trail-making Test [ Time Frame: week 4, 12, 16, 24 ]
  • Change From Baseline in Clock-drawing Test [ Time Frame: week 4, 12, 16, 24 ]
  • Combined Response, i.e. Response in ADAS-COG+ and CIBIC+ [ Time Frame: week 4, 12, 16, 24 ]


Original Secondary Outcome: Same as current

Information By: Ever Neuro Pharma GmbH

Dates:
Date Received: April 20, 2009
Date Started: October 2006
Date Completion:
Last Updated: September 24, 2009
Last Verified: September 2009