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

This study has been completed.
Sponsor:
Collaborators:
acromion GmbH
Geny Research Corp.
Information provided by:
Ever Neuro Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00947531
First received: April 20, 2009
Last updated: September 24, 2009
Last verified: September 2009
Results First Received: April 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Vascular Dementia
Interventions: Drug: Cerebrolysin
Drug: 0.9% Saline Solution

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Date of recruitment period: 24-Oct-2006 - 02-Feb-2007 Type of location: Hospitals, Medical Universities, Medical Military Academy, Research Institutes

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded from the trial before assignment to a group when not all inclusion criteria were met or when exclusion criteria were applicable.

Reporting Groups
  Description
Cerebrolysin No text entered.
0.9% Saline Solution No text entered.

Participant Flow:   Overall Study
    Cerebrolysin     0.9% Saline Solution  
STARTED     121     121  
COMPLETED     107     110  
NOT COMPLETED     14     11  
Withdrawal by Subject                 10                 7  
Administrative Reason                 0                 1  
Adverse Event                 2                 2  
Lack of Efficacy                 1                 0  
unknown                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cerebrolysin No text entered.
0.9% Saline Solution No text entered.
Total Total of all reporting groups

Baseline Measures
    Cerebrolysin     0.9% Saline Solution     Total  
Number of Participants  
[units: participants]
  121     121     242  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     38     39     77  
>=65 years     83     82     165  
Age  
[units: years]
Mean ± Standard Deviation
  67.1  ± 8.0     67.6  ± 8.0     67.3  ± 8.0  
Gender  
[units: participants]
     
Female     82     72     154  
Male     39     49     88  
Region of Enrollment  
[units: participants]
     
Russian Federation     121     121     242  



  Outcome Measures

1.  Primary:   Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24   [ Time Frame: baseline and week 24 ]

2.  Primary:   CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24   [ Time Frame: week 24 ]
Results not yet posted.   Anticipated Posting Date:   09/2009   Safety Issue:   No

3.  Secondary:   Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry, Urinalysis ), ECG (Electrocardiogram)   [ Time Frame: Baseline, week 4, 12, 16, 24 ]
Results not yet posted.   Anticipated Posting Date:   09/2009   Safety Issue:   Yes

4.  Secondary:   Change From Baseline in ADAS-COG+ (Alzheimer’s Disease Assessment Scale Cognitive Subpart)   [ Time Frame: week 4, 12, 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   ADAS-COG+ Response   [ Time Frame: week 4, 12, 16, 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change From Baseline for Original ADAS-COG   [ Time Frame: week 4, 12, 16, 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   CIBIC+ Sscore   [ Time Frame: week 4, 12, 16 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   CIBIC+ Response   [ Time Frame: week 4, 12, 16, 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   CIBIS+ (Clinicians Interview-Based Impression of Severity)   [ Time Frame: week 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Change From Baseline in MMSE (Mini-Mental State Examination) Score   [ Time Frame: week 4, 12, 16, 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)   [ Time Frame: week 4, 12, 16, 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Change From Baseline in Trail-making Test   [ Time Frame: week 4, 12, 16, 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Change From Baseline in Clock-drawing Test   [ Time Frame: week 4, 12, 16, 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Combined Response, i.e. Response in ADAS-COG+ and CIBIC+   [ Time Frame: week 4, 12, 16, 24 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Philipp Novak
Organization: Ebewe Neuro Pharma
phone: +43 7665 8123 ext 733
e-mail: philipp.novak@ebewe-neuro.com


No publications provided


Responsible Party: Philipp Novak, PhD, EBEWE Neuro Pharma
ClinicalTrials.gov Identifier: NCT00947531     History of Changes
Other Study ID Numbers: EBE-RU-051201
Study First Received: April 20, 2009
Results First Received: April 20, 2009
Last Updated: September 24, 2009
Health Authority: Russia: Ministry of Health of the Russian Federation