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

NCT ID: NCT00947531

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-08-31

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.

Conditions

Vascular Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cerebrolysin

Group Type: EXPERIMENTAL

Cerebrolysin

Intervention Type: DRUG

0.9% Saline Solution

Group Type: PLACEBO_COMPARATOR

0.9% Saline Solution

Intervention Type: DRUG

Interventions

Cerebrolysin

Intervention Type: DRUG

0.9% Saline Solution

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

acromion GmbH

INDUSTRY

Sponsor Role: collaborator

Geny Research Corp.

UNKNOWN

Sponsor Role: collaborator

Ever Neuro Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

EBEWE Neuro Pharma

Principal Investigators

Philipp Novak, PhD

Role: STUDY_DIRECTOR

EBEWE Neuro Pharma

Locations

Chita State Medical Academy/Regional Psychiatric Hospital No. 2

Chita, , Russia

Chita State Medical Academy/Veterans Hospital

Chita, , Russia

Irkutsk State Institute of Postgraduate Education/Regional Clinical Hospital

Irkutsk, , Russia

Kazan State Medical University/Municipal Clinical Hospital No. 6

Kazan', , Russia

Kazan State Medical University/Republican Clinical Hospital

Kazan', , Russia

Kursk Medical University/Kursk Regional Clinical Hospital

Kursk, , Russia

I. M. Sechenov Moscow Medical Academy

Moscow, , Russia

Mental Health Research Center of RAMS/Psychiatric Clinical Hospital No. 15

Moscow, , Russia

Mental Health Research Center of RAMS

Moscow, , Russia

Russian Medical Academy of Postgraduate Education/S. P. Botkin Municipal Clinical Hospital

Moscow, , Russia

Russian State Medical University/N. I. Pirogov Municipal Clinical Hospital No. 1

Moscow, , Russia

Scientific Research Institute of Neurology of RAMS

Moscow, , Russia

Municipal Clinical Hospital No. 5

Nizhny Novgorod, , Russia

N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital

Nizhny Novgorod, , Russia

Central Municipal Hospital

Reutov, , Russia

I. P. Pavlov St. Petersburg State Medical University

Saint Petersburg, , Russia

S. M. Kirkov Medical Military Academy of the Ministry of Defense of RF

Saint Petersburg, , Russia

V. M. Bekhterev St. Petersburg Scientific Research Psychoneurological Institute

Saint Petersburg, , Russia

Saratov Regional Psychiatric Hospital of Snt. Sofia

Saratov, , Russia

Bashkirian State Medical University/Emergency Medical Care Hospital

Ufa, , Russia

Yaroslavl State Medical Academy/Yaroslavl Clinical Hospital No. 8

Yaroslavl, , Russia

Countries

Russia

References

Guekht AB, Moessler H, Novak PH, Gusev EI; Cerebrolysin Investigators. Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial. J Stroke Cerebrovasc Dis. 2011 Jul-Aug;20(4):310-8. doi: 10.1016/j.jstrokecerebrovasdis.2010.01.012. Epub 2010 Jul 24.

Reference Type: RESULT

PMID: 20656516 (View on PubMed)

Other Identifiers

EBE-RU-051201

Identifier Type: -

Identifier Source: org_study_id