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

This study has been completed.
Sponsor:
Collaborators:
acromion GmbH
Geny Research Corp.
Information provided by:
Ever Neuro Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00947531
First received: April 20, 2009
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Vascular Dementia
Drug: Cerebrolysin
Drug: 0.9% Saline Solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ever Neuro Pharma GmbH:

Primary Outcome Measures:
  • Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24 [ Time Frame: baseline and week 24 ] [ Designated as safety issue: No ]
  • CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry, Urinalysis ), ECG (Electrocardiogram) [ Time Frame: Baseline, week 4, 12, 16, 24 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart) [ Time Frame: week 4, 12, 16 ] [ Designated as safety issue: No ]
  • ADAS-COG+ Response [ Time Frame: week 4, 12, 16, 24 ] [ Designated as safety issue: No ]
  • Change From Baseline for Original ADAS-COG [ Time Frame: week 4, 12, 16, 24 ] [ Designated as safety issue: No ]
  • CIBIC+ Sscore [ Time Frame: week 4, 12, 16 ] [ Designated as safety issue: No ]
  • CIBIC+ Response [ Time Frame: week 4, 12, 16, 24 ] [ Designated as safety issue: No ]
  • CIBIS+ (Clinicians Interview-Based Impression of Severity) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in MMSE (Mini-Mental State Examination) Score [ Time Frame: week 4, 12, 16, 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale) [ Time Frame: week 4, 12, 16, 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Trail-making Test [ Time Frame: week 4, 12, 16, 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Clock-drawing Test [ Time Frame: week 4, 12, 16, 24 ] [ Designated as safety issue: No ]
  • Combined Response, i.e. Response in ADAS-COG+ and CIBIC+ [ Time Frame: week 4, 12, 16, 24 ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: October 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Experimental: Cerebrolysin Drug: Cerebrolysin
Placebo Comparator: 0.9% Saline Solution Drug: 0.9% Saline Solution

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947531

Locations
Russian Federation
Chita State Medical Academy/Veterans Hospital
Chita, Russian Federation
Chita State Medical Academy/Regional Psychiatric Hospital No. 2
Chita, Russian Federation
Irkutsk State Institute of Postgraduate Education/Regional Clinical Hospital
Irkutsk, Russian Federation
Kazan State Medical University/Republican Clinical Hospital
Kazan, Russian Federation
Kazan State Medical University/Municipal Clinical Hospital No. 6
Kazan, Russian Federation
Kursk Medical University/Kursk Regional Clinical Hospital
Kursk, Russian Federation
I. M. Sechenov Moscow Medical Academy
Moscow, Russian Federation
Mental Health Research Center of RAMS
Moscow, Russian Federation
Scientific Research Institute of Neurology of RAMS
Moscow, Russian Federation
Russian Medical Academy of Postgraduate Education/S. P. Botkin Municipal Clinical Hospital
Moscow, Russian Federation
Russian State Medical University/N. I. Pirogov Municipal Clinical Hospital No. 1
Moscow, Russian Federation
Mental Health Research Center of RAMS/Psychiatric Clinical Hospital No. 15
Moscow, Russian Federation
Municipal Clinical Hospital No. 5
Nizhniy Novgorod, Russian Federation
N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital
Nizhniy Novgorod, Russian Federation
Central Municipal Hospital
Reutov, Russian Federation
Saratov Regional Psychiatric Hospital of Snt. Sofia
Saratov, Russian Federation
V. M. Bekhterev St. Petersburg Scientific Research Psychoneurological Institute
St. Petersburg, Russian Federation
I. P. Pavlov St. Petersburg State Medical University
St. Petersburg, Russian Federation
S. M. Kirkov Medical Military Academy of the Ministry of Defense of RF
St. Petersburg, Russian Federation
Bashkirian State Medical University/Emergency Medical Care Hospital
Ufa, Russian Federation
Yaroslavl State Medical Academy/Yaroslavl Clinical Hospital No. 8
Yaroslavl, Russian Federation
Sponsors and Collaborators
Ever Neuro Pharma GmbH
acromion GmbH
Geny Research Corp.
Investigators
Study Director: Philipp Novak, PhD EBEWE Neuro Pharma
  More Information

No publications provided

Responsible Party: Philipp Novak, PhD, EBEWE Neuro Pharma
ClinicalTrials.gov Identifier: NCT00947531     History of Changes
Other Study ID Numbers: EBE-RU-051201
Study First Received: April 20, 2009
Results First Received: April 20, 2009
Last Updated: September 24, 2009
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrolysin
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014