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

NCT00947531 | Completed Phase 4 Results

• 1 other identifier: EBE-RU-051201
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 21

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

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24

  The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.

  baseline and week 24

• CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24

  This rating scale is based on the health care provider's "general clinical impressions" with the informant input (i.e. family members). It evaluates global function and is scored from 1 (marked improvement) to 7 (marked worsening).

  week 24

Secondary Outcomes (11)

• Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)

  week 4, 12, 16

• ADAS-COG+ Response

  week 4, 12, 16, 24

• Change From Baseline for Original ADAS-COG

  week 4, 12, 16, 24

• CIBIC+ Score

  week 4, 12, 16

• CIBIC+ Response

  week 4, 12, 16, 24

Study Arms (2)

Cerebrolysin

EXPERIMENTAL

Drug: Cerebrolysin

0.9% Saline Solution

PLACEBO COMPARATOR

Drug: 0.9% Saline Solution

Interventions

Cerebrolysin DRUG

Cerebrolysin

0.9% Saline Solution DRUG

0.9% Saline Solution

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ever Neuro Pharma GmbH: lead
• acromion GmbH: collaborator
• Geny Research Corp.: collaborator

Study Sites (21)

Chita State Medical Academy/Regional Psychiatric Hospital No. 2

Chita, Russia

Location

Chita State Medical Academy/Veterans Hospital

Chita, Russia

Location

Irkutsk State Institute of Postgraduate Education/Regional Clinical Hospital

Irkutsk, Russia

Location

Kazan State Medical University/Municipal Clinical Hospital No. 6

Kazan', Russia

Location

Kazan State Medical University/Republican Clinical Hospital

Kazan', Russia

Location

Kursk Medical University/Kursk Regional Clinical Hospital

Kursk, Russia

Location

I. M. Sechenov Moscow Medical Academy

Moscow, Russia

Location

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

Moscow, Russia

Location

Mental Health Research Center of RAMS

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

Scientific Research Institute of Neurology of RAMS

Moscow, Russia

Location

Municipal Clinical Hospital No. 5

Nizhny Novgorod, Russia

Location

N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital

Nizhny Novgorod, Russia

Location

Central Municipal Hospital

Reutov, Russia

Location

I. P. Pavlov St. Petersburg State Medical University

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Saratov Regional Psychiatric Hospital of Snt. Sofia

Saratov, Russia

Location

Bashkirian State Medical University/Emergency Medical Care Hospital

Ufa, Russia

Location

Yaroslavl State Medical Academy/Yaroslavl Clinical Hospital No. 8

Yaroslavl, Russia

Location

Related Publications (1)

• 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.

  PMID: 20656516 RESULT

MeSH Terms

Conditions

Dementia, Vascular

Interventions

cerebrolysin; Saline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Head of R&D
• Organization: EVERNeuro Pharma

stefan.winter@everpharma.com

+43 7665 20555

Study Officials

• Philipp Novak, PhD

  EBEWE Neuro Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: July 28, 2009
• Study Start: October 1, 2006
• Study Completion: August 1, 2007
• Last Updated: February 21, 2024
• Results First Posted: July 28, 2009

Record last verified: 2024-02

Locations

RU (21)