Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial.

Guekht AB, Moessler H, Novak PH, Gusev EI

Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association24 Jul 2010Cited by 36 (Europe PMC)

PMID20656516DOI10.1016/j.jstrokecerebrovasdis.2010.01.012PepBankPUB-20656516

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In vascular dementia, Cerebrolysin improved ADAS-cog+ more than placebo at week 24.
In plain wordsIn vascular dementia, Cerebrolysin improved cognition more than placebo at week 24.
Peptide
Cerebrolysin
Outcome
DecreaseADAS-cog+ at week 24
Study
n = 242
Comparator
Placebo with basic acetylsalicylic acid treatment
Analysis
Primary
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
20 mL · IntravenousAs given in this study (human).
Measurements
ADAS-cog+ improvement
10.6 points
Cerebrolysin
ADAS-cog+ improvement
4.4 points
placebo
Least squares mean difference
−6.17 points
versus placebo
P value for ADAS-cog+ improvement
< 0.0001
Cerebrolysin versus placebo at week 24
Source sentences
Summary
At week 24, ADAS-cog+ score improved by 10.6 points in the Cerebrolysin group, compared with 4.4 points in the placebo group (least squares mean difference, -6.17; P < .0001 vs placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD.
Summary · context
Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid.
Report a problemFND-2065651601
02HumanRandomized controlled trialEfficacy outcome
In vascular dementia, Cerebrolysin improved CIBIC+ more than placebo at week 24.
In plain wordsIn vascular dementia, Cerebrolysin improved global clinical function more than placebo at week 24.
Peptide
Cerebrolysin
Outcome
DecreaseCIBIC+ at week 24
Study
n = 242
Comparator
Placebo with basic acetylsalicylic acid treatment
Analysis
Primary
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
20 mL · IntravenousAs given in this study (human).
Measurements
CIBIC+
2.84 score
Cerebrolysin
CIBIC+
3.68 score
placebo
Treatment difference
0.84 score
versus placebo
P value for CIBIC+ improvement
< 0.0001
Cerebrolysin versus placebo at week 24
Source sentences
Summary
CIBIC+ showed a mean improvement of 2.84 in the treatment arm and 3.68 in the placebo arm, a treatment difference of 0.84 (P < .0001 vs placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD.
Summary · context
Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid.
Report a problemFND-2065651602
03HumanRandomized controlled trialEfficacy outcome
In vascular dementia, Cerebrolysin increased the proportion with ADAS-cog+ improvement of ≥4 points versus placebo.
In plain wordsIn vascular dementia, Cerebrolysin produced more cognition responders than placebo.
Peptide
Cerebrolysin
Outcome
IncreaseADAS-cog+ responder proportion
Study
n = 242
Comparator
Placebo with basic acetylsalicylic acid treatment
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
20 mL · IntravenousAs given in this study (human).
Measurements
Responders
82.1%
Cerebrolysin
Responders
52.2%
placebo
Source sentences
Summary
These findings were confirmed by responder analyses demonstrating higher rates in the Cerebrolysin group (ADAS-cog+ improvement of ≥4 points from baseline, 82.1% vs 52.2%; CIBIC+ score of <4 at week 24, 75.3% vs 37.4%; combined response in ADAS-cog+ and CIBIC+, 67.5% vs 27.0%).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD.
Summary · context
Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid.
Report a problemFND-2065651603
04HumanRandomized controlled trialEfficacy outcome
In vascular dementia, Cerebrolysin increased the proportion with CIBIC+ score <4 at week 24 versus placebo.
In plain wordsIn vascular dementia, Cerebrolysin produced more global clinical responders than placebo.
Peptide
Cerebrolysin
Outcome
IncreaseCIBIC+ responder proportion
Study
n = 242
Comparator
Placebo with basic acetylsalicylic acid treatment
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
20 mL · IntravenousAs given in this study (human).
Measurements
Responders
75.3%
Cerebrolysin
Responders
37.4%
placebo
Odds ratio
5.08
favorable CIBIC+ response
P value for Favorable CIBIC+ response odds ratio
< 0.05
Cerebrolysin versus placebo at week 24
Source sentences
Summary
These findings were confirmed by responder analyses demonstrating higher rates in the Cerebrolysin group (ADAS-cog+ improvement of ≥4 points from baseline, 82.1% vs 52.2%; CIBIC+ score of <4 at week 24, 75.3% vs 37.4%; combined response in ADAS-cog+ and CIBIC+, 67.5% vs 27.0%).
3 context sentences(design, population, supporting numbers)
Summary · context
For Cerebrolysin, the odds ratio for achieving a favorable CIBIC+ response was 5.08 (P < .05), and that for achieving a favorable combined response was 5.63 (P < .05).
Summary · context
We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD.
Summary · context
Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid.
Report a problemFND-2065651604
05HumanRandomized controlled trialEfficacy outcome
In vascular dementia, Cerebrolysin increased combined ADAS-cog+ and CIBIC+ response versus placebo.
In plain wordsIn vascular dementia, Cerebrolysin produced more combined cognition and global clinical responders than placebo.
Peptide
Cerebrolysin
Outcome
IncreaseCombined ADAS-cog+ and CIBIC+ response
Study
n = 242
Comparator
Placebo with basic acetylsalicylic acid treatment
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
20 mL · IntravenousAs given in this study (human).
Measurements
Combined response
67.5%
Cerebrolysin
Combined response
27%
placebo
Odds ratio
5.63
favorable combined response
P value for Favorable combined ADAS-cog+ and CIBIC+ response odds ratio
< 0.05
Cerebrolysin versus placebo at week 24
Source sentences
Summary
These findings were confirmed by responder analyses demonstrating higher rates in the Cerebrolysin group (ADAS-cog+ improvement of ≥4 points from baseline, 82.1% vs 52.2%; CIBIC+ score of <4 at week 24, 75.3% vs 37.4%; combined response in ADAS-cog+ and CIBIC+, 67.5% vs 27.0%).
3 context sentences(design, population, supporting numbers)
Summary · context
For Cerebrolysin, the odds ratio for achieving a favorable CIBIC+ response was 5.08 (P < .05), and that for achieving a favorable combined response was 5.63 (P < .05).
Summary · context
We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD.
Summary · context
Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid.
Report a problemFND-2065651605
06HumanRandomized controlled trialSafety outcome
In vascular dementia, Cerebrolysin was reported as safe and well tolerated.
In plain wordsIn vascular dementia, the study reported Cerebrolysin as safe and well tolerated.
Peptide
Cerebrolysin
Outcome
Not applicableSafety and tolerability
Study
n = 242
Outcome group
Adverse events · Whole body
Studied dose
20 mL · IntravenousAs given in this study (human).
Source sentences
Summary
Cerebrolysin was safe and well tolerated.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD.
Summary · context
Intravenous Cerebrolysin 20 mL was administered once daily over the course of 2 treatment cycles as add-on therapy to basic treatment with acetylsalicylic acid.
Report a problemFND-2065651606

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT00947531

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

Ever Neuro Pharma GmbHn = 242Oct 2006 to Aug 2007

Vascular Dementia

Trial page ClinicalTrials.govUpdated 21 Feb 2024

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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