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:
Ever Neuro Pharma GmbH
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
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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 May 16, 2013