Clinical trial NCT00947531: A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vascular Dementia
Lead sponsor: Ever Neuro Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: acromion GmbH
name: Geny Research Corp.
First posted: 2009-07-28
Enrollment: 242
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
timeFrame: baseline and week 24
measure: CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24
timeFrame: week 24
Secondary outcomes:
measure: Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)
timeFrame: week 4, 12, 16
measure: ADAS-COG+ Response
timeFrame: week 4, 12, 16, 24
measure: Change From Baseline for Original ADAS-COG
timeFrame: week 4, 12, 16, 24
measure: CIBIC+ Score
timeFrame: week 4, 12, 16
measure: CIBIC+ Response
timeFrame: week 4, 12, 16, 24
measure: CIBIS+ (Clinicians Interview-Based Impression of Severity)
timeFrame: week 24
measure: Change From Baseline in MMSE (Mini-Mental State Examination) Score
timeFrame: week 4, 12, 16, 24
measure: Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)
timeFrame: week 4, 12, 16, 24
measure: Change From Baseline in Trail-making Test
timeFrame: week 4, 12, 16, 24
measure: Change From Baseline in Clock-drawing Test
timeFrame: week 4, 12, 16, 24
measure: Combined Response, i.e. Response in ADAS-COG+ and CIBIC+
timeFrame: week 4, 12, 16, 24
Other outcomes:
Locations:
city: Chita
country: Russian Federation
facility: Chita State Medical Academy/Regional Psychiatric Hospital No. 2
city: Chita
country: Russian Federation
facility: Chita State Medical Academy/Veterans Hospital
city: Irkutsk
country: Russian Federation
facility: Irkutsk State Institute of Postgraduate Education/Regional Clinical Hospital
city: Kazan
country: Russian Federation
facility: Kazan State Medical University/Municipal Clinical Hospital No. 6
city: Kazan
country: Russian Federation
facility: Kazan State Medical University/Republican Clinical Hospital
city: Kursk
country: Russian Federation
facility: Kursk Medical University/Kursk Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: I. M. Sechenov Moscow Medical Academy
city: Moscow
country: Russian Federation
facility: Mental Health Research Center of RAMS/Psychiatric Clinical Hospital No. 15
city: Moscow
country: Russian Federation
facility: Mental Health Research Center of RAMS
city: Moscow
country: Russian Federation
facility: Russian Medical Academy of Postgraduate Education/S. P. Botkin Municipal Clinical Hospital
city: Moscow
country: Russian Federation
facility: Russian State Medical University/N. I. Pirogov Municipal Clinical Hospital No. 1
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Neurology of RAMS
city: Nizhniy Novgorod
country: Russian Federation
facility: Municipal Clinical Hospital No. 5
city: Nizhniy Novgorod
country: Russian Federation
facility: N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital
city: Reutov
country: Russian Federation
facility: Central Municipal Hospital
city: Saratov
country: Russian Federation
facility: Saratov Regional Psychiatric Hospital of Snt. Sofia
city: St. Petersburg
country: Russian Federation
facility: I. P. Pavlov St. Petersburg State Medical University
city: St. Petersburg
country: Russian Federation
facility: S. M. Kirkov Medical Military Academy of the Ministry of Defense of RF
city: St. Petersburg
country: Russian Federation
facility: V. M. Bekhterev St. Petersburg Scientific Research Psychoneurological Institute
city: Ufa
country: Russian Federation
facility: Bashkirian State Medical University/Emergency Medical Care Hospital
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl State Medical Academy/Yaroslavl Clinical Hospital No. 8
Study officials:
affiliation: EBEWE Neuro Pharma
name: Philipp Novak, PhD
role: STUDY_DIRECTOR
References:
citation: 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.