A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular
Intervention: Cerebrolysin; 0.9% Saline Solution
Intervention MeSH terms: Cerebrolysin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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