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

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ClinicalTrials.gov Identifier: NCT00947531
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : July 28, 2009
Last Update Posted : September 30, 2009
Sponsor:
Collaborators:
acromion GmbH
Geny Research Corp.
Information provided by:
Ever Neuro Pharma GmbH

Tracking Information
First Submitted Date  ICMJE April 20, 2009
First Posted Date  ICMJE July 28, 2009
Results First Submitted Date  ICMJE April 20, 2009
Results First Posted Date  ICMJE July 28, 2009
Last Update Posted Date September 30, 2009
Study Start Date  ICMJE October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
  • 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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00947531 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vascular Dementia
Intervention  ICMJE
  • Drug: Cerebrolysin
  • Drug: 0.9% Saline Solution
Study Arms  ICMJE
  • Experimental: Cerebrolysin
    Intervention: Drug: Cerebrolysin
  • Placebo Comparator: 0.9% Saline Solution
    Intervention: Drug: 0.9% Saline Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2009)
242
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947531
Other Study ID Numbers  ICMJE EBE-RU-051201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philipp Novak, PhD, EBEWE Neuro Pharma
Study Sponsor  ICMJE Ever Neuro Pharma GmbH
Collaborators  ICMJE
  • acromion GmbH
  • Geny Research Corp.
Investigators  ICMJE
Study Director: Philipp Novak, PhD EBEWE Neuro Pharma
PRS Account Ever Neuro Pharma GmbH
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP