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

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ClinicalTrials.gov Identifier: NCT00947531
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : July 28, 2009
Last Update Posted : September 30, 2009
Sponsor:
Collaborators:
acromion GmbH
Geny Research Corp.
Information provided by:
Ever Neuro Pharma GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Vascular Dementia
Interventions Drug: Cerebrolysin
Drug: 0.9% Saline Solution
Enrollment 242
Recruitment Details Date of recruitment period: 24-Oct-2006 - 02-Feb-2007 Type of location: Hospitals, Medical Universities, Medical Military Academy, Research Institutes
Pre-assignment Details Patients were excluded from the trial before assignment to a group when not all inclusion criteria were met or when exclusion criteria were applicable.
Arm/Group Title Cerebrolysin 0.9% Saline Solution
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 121 121
Completed 107 110
Not Completed 14 11
Reason Not Completed
Withdrawal by Subject             10             7
Administrative Reason             0             1
Adverse Event             2             2
Lack of Efficacy             1             0
Other             1             1
Arm/Group Title Cerebrolysin 0.9% Saline Solution Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 121 121 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 121 participants 242 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  31.4%
39
  32.2%
77
  31.8%
>=65 years
83
  68.6%
82
  67.8%
165
  68.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 121 participants 242 participants
67.1  (8.0) 67.6  (8.0) 67.3  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 121 participants 242 participants
Female
82
  67.8%
72
  59.5%
154
  63.6%
Male
39
  32.2%
49
  40.5%
88
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russian Federation Number Analyzed 121 participants 121 participants 242 participants
121 121 242
1.Primary Outcome
Title Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cerebrolysin 0.9% Saline Solution
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 117 115
Mean (Standard Deviation)
Unit of Measure: points on a scale
-10.60  (7.77) -4.49  (8.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cerebrolysin, 0.9% Saline Solution
Comments The null-hypothesis stated no difference between the two treatment groups. A sample size of 103 evaluable patients per treatment group was estimated to allow for the detection of a significant group difference of 4.1 points in ADAS-cog+ weak 24 change score (standard deviation [SD] 9.0) in favor of Cerebrolysin with a power of 90% and a probability level of alpha-level 0.025 (one-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value obtained from the F-test statistic of Cerebrolysin versus Placebo as part of ANCOVA (analysis of covariance). No adjustment for multiple comparisons was needed. The overall significance level alpha was fixed at alpha = 0.05 (two-sided).
Method ANCOVA
Comments The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple comparisons was needed.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.17
Confidence Interval 95%
-8.22 to -4.13
Estimation Comments [Not Specified]
2.Primary Outcome
Title CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24
Hide Description [Not Specified]
Time Frame week 24
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry, Urinalysis ), ECG (Electrocardiogram)
Hide Description [Not Specified]
Time Frame Baseline, week 4, 12, 16, 24
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change From Baseline in ADAS-COG+ (Alzheimer’s Disease Assessment Scale Cognitive Subpart)
Hide 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
Outcome Measure Data Not Reported
5.Secondary Outcome
Title ADAS-COG+ Response
Hide 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
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change From Baseline for Original ADAS-COG
Hide 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
Outcome Measure Data Not Reported
7.Secondary Outcome
Title CIBIC+ Sscore
Hide 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
Outcome Measure Data Not Reported
8.Secondary Outcome
Title CIBIC+ Response
Hide 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
Outcome Measure Data Not Reported
9.Secondary Outcome
Title CIBIS+ (Clinicians Interview-Based Impression of Severity)
Hide 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
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change From Baseline in MMSE (Mini-Mental State Examination) Score
Hide 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
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)
Hide 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
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Change From Baseline in Trail-making Test
Hide Description The Trail-making test is a frequently used instrument for the assessment of executive function.
Time Frame week 4, 12, 16, 24
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Change From Baseline in Clock-drawing Test
Hide 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
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Combined Response, i.e. Response in ADAS-COG+ and CIBIC+
Hide Description [Not Specified]
Time Frame week 4, 12, 16, 24
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cerebrolysin 0.9% Saline Solution
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Cerebrolysin 0.9% Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cerebrolysin 0.9% Saline Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3      0    
Infections and infestations     
Pyelonephritis acute   1/117 (0.85%)  1 0/115 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant   1/117 (0.85%)  1 0/115 (0.00%)  0
Rectosigmoid cancer   1/117 (0.85%)  1 0/115 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cerebrolysin 0.9% Saline Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Philipp Novak
Organization: Ebewe Neuro Pharma
Phone: +43 7665 8123 ext 733
Responsible Party: Philipp Novak, PhD, EBEWE Neuro Pharma
ClinicalTrials.gov Identifier: NCT00947531     History of Changes
Other Study ID Numbers: EBE-RU-051201
First Submitted: April 20, 2009
First Posted: July 28, 2009
Results First Submitted: April 20, 2009
Results First Posted: July 28, 2009
Last Update Posted: September 30, 2009