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| Name | Class |
|---|---|
| acromion GmbH | INDUSTRY |
| Geny Research Corp. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebrolysin | Experimental |
| |
| 0.9% Saline Solution | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebrolysin | Drug |
| ||
| 0.9% Saline Solution |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart) | The modified Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG+) is a psychometric instrument used by a neuropsychologist that evaluates memory, attention, reasoning, language, orientation and praxis. | week 4, 12, 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Novak, PhD | EBEWE Neuro Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chita State Medical Academy/Regional Psychiatric Hospital No. 2 | Chita | Russia | ||||
| Chita State Medical Academy/Veterans Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20656516 | Result | 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. |
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Patients were excluded from the trial before assignment to a group when not all inclusion criteria were met or when exclusion criteria were applicable.
Date of recruitment period: 24-Oct-2006 - 02-Feb-2007 Type of location: Hospitals, Medical Universities, Medical Military Academy, Research Institutes
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| ID | Title | Description |
|---|---|---|
| FG000 | Cerebrolysin | |
| FG001 | 0.9% Saline Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ADAS-COG+ Response |
A patient with an improvement from baseline of ≥ 4 points in the ADAS-COG+ score at a particular visit is considered to have an ADAS-COG+ response at that visit. |
| week 4, 12, 16, 24 |
| Change From Baseline for Original ADAS-COG | The Original Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+. | week 4, 12, 16, 24 |
| CIBIC+ Score | The Clinician Interview-based Impression of Change (CIBIC+) score is assigned by an experienced physician familiar with the manifestations of dementia after interviewing the patient and the caregiver. | week 4, 12, 16 |
| CIBIC+ Response | A patient with a CIBIC+ score of 1 to 3 at a particular visit is considered to have a CIBIC+ response at that visit. Patients with a score of 0, indicating that the assessment was not performed, are considered to be non-responders. | week 4, 12, 16, 24 |
| CIBIS+ (Clinicians Interview-Based Impression of Severity) | The Clinician Interview-based Impression of Disease Severity (CIBIS+) score is assigned by an experienced physician, familiar with the manifestations of dementia, after interviewing the patient and the caregiver. | week 24 |
| Change From Baseline in MMSE (Mini-Mental State Examination) Score | The Mini-Mental State Examination (MMSE) is a frequently used screening instrument for clinical trials conducted in patients with Alzheimer's Disease. It evaluates orientation, registration, attention and calculation, recall and language. | week 4, 12, 16, 24 |
| Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale) | The ADCS-ADL is a measure of functional disability. The ADCS-ADL assessment of activities of daily living is based on an interview with the caregiver. | week 4, 12, 16, 24 |
| Change From Baseline in Trail-making Test | The Trail-making test is a frequently used instrument for the assessment of executive function. | week 4, 12, 16, 24 |
| Change From Baseline in Clock-drawing Test | The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients. | week 4, 12, 16, 24 |
| Combined Response, i.e. Response in ADAS-COG+ and CIBIC+ | week 4, 12, 16, 24 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cerebrolysin | |
| BG001 | 0.9% Saline Solution | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary and confirmatory analysis is based on the ITT analysis set. The LOCF method is applied to account for missing data. The ITT analysis set consists of all randomized patients, who received at least one dose of study medication and had a baseline and at least one post-baseline assessment for both primary efficacy measures. | Posted | Jun 2008 | Mean | Standard Deviation | points on a scale | baseline and week 24 |
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| Primary | 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). | Posted | Count of Participants | Participants | week 24 |
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| Secondary | Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart) | The modified Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG+) is a psychometric instrument used by a neuropsychologist that evaluates memory, attention, reasoning, language, orientation and praxis. | Not Posted | week 4, 12, 16 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ADAS-COG+ Response | A patient with an improvement from baseline of ≥ 4 points in the ADAS-COG+ score at a particular visit is considered to have an ADAS-COG+ response at that visit. | Not Posted | week 4, 12, 16, 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Original ADAS-COG | The Original Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+. | Not Posted | week 4, 12, 16, 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CIBIC+ Score | The Clinician Interview-based Impression of Change (CIBIC+) score is assigned by an experienced physician familiar with the manifestations of dementia after interviewing the patient and the caregiver. | Not Posted | week 4, 12, 16 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CIBIC+ Response | A patient with a CIBIC+ score of 1 to 3 at a particular visit is considered to have a CIBIC+ response at that visit. Patients with a score of 0, indicating that the assessment was not performed, are considered to be non-responders. | Not Posted | week 4, 12, 16, 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CIBIS+ (Clinicians Interview-Based Impression of Severity) | The Clinician Interview-based Impression of Disease Severity (CIBIS+) score is assigned by an experienced physician, familiar with the manifestations of dementia, after interviewing the patient and the caregiver. | Not Posted | week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in MMSE (Mini-Mental State Examination) Score | The Mini-Mental State Examination (MMSE) is a frequently used screening instrument for clinical trials conducted in patients with Alzheimer's Disease. It evaluates orientation, registration, attention and calculation, recall and language. | Not Posted | week 4, 12, 16, 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale) | The ADCS-ADL is a measure of functional disability. The ADCS-ADL assessment of activities of daily living is based on an interview with the caregiver. | Not Posted | week 4, 12, 16, 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Trail-making Test | The Trail-making test is a frequently used instrument for the assessment of executive function. | Not Posted | week 4, 12, 16, 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clock-drawing Test | The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients. | Not Posted | week 4, 12, 16, 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Combined Response, i.e. Response in ADAS-COG+ and CIBIC+ | Not Posted | week 4, 12, 16, 24 | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cerebrolysin | 3 | 0 | 117 | ||||
| EG001 | 0.9% Saline Solution | 0 | 0 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
| ||
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Rectosigmoid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D | EVERNeuro Pharma | +43 7665 20555 | 0 | stefan.winter@everpharma.com |
| ID | Term |
|---|---|
| D015140 | Dementia, Vascular |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C006952 | cerebrolysin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| Male |
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| Superiority or Other (legacy) |
|