Back to resultsA Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia (VascDem)
Primary Purpose
Vascular Dementia
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Cerebrolysin
0.9% Saline Solution
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Dementia
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
Sites / Locations
- Chita State Medical Academy/Regional Psychiatric Hospital No. 2
- Chita State Medical Academy/Veterans Hospital
- Irkutsk State Institute of Postgraduate Education/Regional Clinical Hospital
- Kazan State Medical University/Municipal Clinical Hospital No. 6
- Kazan State Medical University/Republican Clinical Hospital
- Kursk Medical University/Kursk Regional Clinical Hospital
- I. M. Sechenov Moscow Medical Academy
- Mental Health Research Center of RAMS/Psychiatric Clinical Hospital No. 15
- Mental Health Research Center of RAMS
- Russian Medical Academy of Postgraduate Education/S. P. Botkin Municipal Clinical Hospital
- Russian State Medical University/N. I. Pirogov Municipal Clinical Hospital No. 1
- Scientific Research Institute of Neurology of RAMS
- Municipal Clinical Hospital No. 5
- N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital
- Central Municipal Hospital
- Saratov Regional Psychiatric Hospital of Snt. Sofia
- I. P. Pavlov St. Petersburg State Medical University
- S. M. Kirkov Medical Military Academy of the Ministry of Defense of RF
- V. M. Bekhterev St. Petersburg Scientific Research Psychoneurological Institute
- Bashkirian State Medical University/Emergency Medical Care Hospital
- Yaroslavl State Medical Academy/Yaroslavl Clinical Hospital No. 8
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cerebrolysin
0.9% Saline Solution
Arm Description
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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.
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.
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+.
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.
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.
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.
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.
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.
Change From Baseline in Trail-making Test
The Trail-making test is a frequently used instrument for the assessment of executive function.
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.
Combined Response, i.e. Response in ADAS-COG+ and CIBIC+
Full Information
NCT ID
NCT00947531
First Posted
April 20, 2009
Last Updated
July 30, 2020
Sponsor
Ever Neuro Pharma GmbH
Collaborators
acromion GmbH, Geny Research Corp.
1. Study Identification
Unique Protocol Identification Number
NCT00947531
Brief Title
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
Acronym
VascDem
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ever Neuro Pharma GmbH
Collaborators
acromion GmbH, Geny Research Corp.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cerebrolysin
Arm Type
Experimental
Arm Title
0.9% Saline Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin
Intervention Type
Drug
Intervention Name(s)
0.9% Saline Solution
Primary Outcome Measure Information:
Title
Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
Description
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.
Time Frame
baseline and week 24
Title
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24
Description
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).
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)
Description
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.
Time Frame
week 4, 12, 16
Title
ADAS-COG+ Response
Description
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.
Time Frame
week 4, 12, 16, 24
Title
Change From Baseline for Original ADAS-COG
Description
The Original Alzheimer's Disease Assessment Scale - Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.
Time Frame
week 4, 12, 16, 24
Title
CIBIC+ Score
Description
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.
Time Frame
week 4, 12, 16
Title
CIBIC+ Response
Description
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.
Time Frame
week 4, 12, 16, 24
Title
CIBIS+ (Clinicians Interview-Based Impression of Severity)
Description
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.
Time Frame
week 24
Title
Change From Baseline in MMSE (Mini-Mental State Examination) Score
Description
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.
Time Frame
week 4, 12, 16, 24
Title
Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)
Description
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.
Time Frame
week 4, 12, 16, 24
Title
Change From Baseline in Trail-making Test
Description
The Trail-making test is a frequently used instrument for the assessment of executive function.
Time Frame
week 4, 12, 16, 24
Title
Change From Baseline in Clock-drawing Test
Description
The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.
Time Frame
week 4, 12, 16, 24
Title
Combined Response, i.e. Response in ADAS-COG+ and CIBIC+
Time Frame
week 4, 12, 16, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Novak, PhD
Organizational Affiliation
EBEWE Neuro Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Chita State Medical Academy/Regional Psychiatric Hospital No. 2
City
Chita
Country
Russian Federation
Facility Name
Chita State Medical Academy/Veterans Hospital
City
Chita
Country
Russian Federation
Facility Name
Irkutsk State Institute of Postgraduate Education/Regional Clinical Hospital
City
Irkutsk
Country
Russian Federation
Facility Name
Kazan State Medical University/Municipal Clinical Hospital No. 6
City
Kazan
Country
Russian Federation
Facility Name
Kazan State Medical University/Republican Clinical Hospital
City
Kazan
Country
Russian Federation
Facility Name
Kursk Medical University/Kursk Regional Clinical Hospital
City
Kursk
Country
Russian Federation
Facility Name
I. M. Sechenov Moscow Medical Academy
City
Moscow
Country
Russian Federation
Facility Name
Mental Health Research Center of RAMS/Psychiatric Clinical Hospital No. 15
City
Moscow
Country
Russian Federation
Facility Name
Mental Health Research Center of RAMS
City
Moscow
Country
Russian Federation
Facility Name
Russian Medical Academy of Postgraduate Education/S. P. Botkin Municipal Clinical Hospital
City
Moscow
Country
Russian Federation
Facility Name
Russian State Medical University/N. I. Pirogov Municipal Clinical Hospital No. 1
City
Moscow
Country
Russian Federation
Facility Name
Scientific Research Institute of Neurology of RAMS
City
Moscow
Country
Russian Federation
Facility Name
Municipal Clinical Hospital No. 5
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Central Municipal Hospital
City
Reutov
Country
Russian Federation
Facility Name
Saratov Regional Psychiatric Hospital of Snt. Sofia
City
Saratov
Country
Russian Federation
Facility Name
I. P. Pavlov St. Petersburg State Medical University
City
St. Petersburg
Country
Russian Federation
Facility Name
S. M. Kirkov Medical Military Academy of the Ministry of Defense of RF
City
St. Petersburg
Country
Russian Federation
Facility Name
V. M. Bekhterev St. Petersburg Scientific Research Psychoneurological Institute
City
St. Petersburg
Country
Russian Federation
Facility Name
Bashkirian State Medical University/Emergency Medical Care Hospital
City
Ufa
Country
Russian Federation
Facility Name
Yaroslavl State Medical Academy/Yaroslavl Clinical Hospital No. 8
City
Yaroslavl
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
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