A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease.

Alvarez XA, Cacabelos R, Laredo M, Couceiro V, Sampedro C, Varela M, Corzo L, Fernandez-Novoa L, Vargas M, Aleixandre M, Linares C, Granizo E, Muresanu D, Moessler H

European journal of neurology1 Jan 2006Cited by 53 (Europe PMC)

PMID16420392DOI10.1111/j.1468-1331.2006.01222.xPepBankPUB-16420392

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

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

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialSafety outcome
In patients with Alzheimer's disease, adverse-event reporting was similar across Cerebrolysin dose groups and placebo.
In plain wordsIn patients with Alzheimer's disease, adverse-event reporting was similar with Cerebrolysin and placebo.
Peptide
Cerebrolysin
Outcome
No significant changePatients reporting adverse events
Study
n = 279
Comparator
Placebo
Outcome group
Adverse events · Nervous system and cognition
Studied dose
10, 30, 60 ml · iv infusion · 12 weeksAs given in this study (human).
Source sentences
Summary
The percentage of patients reporting adverse events was similar across all study groups.
3 context sentences(design, population, supporting numbers)
Summary · context
The efficacy and safety of three dosages of Cere were investigated in this randomized, double-blind, placebo-controlled, study.
Summary · context
Patients received iv infusions of 10, 30, 60 ml Cere or placebo 5 days/week for the first 4 weeks and thereafter, two iv infusions per week for 8 weeks.
Summary · context
Effects on cognition and clinical global impressions were evaluated 4, 12 and 24 weeks after the beginning of the infusions using the CIBIC+ and the modified Alzheimer's Disease Assessment Scale (ADAS)-cog.
Report a problemFND-1642039207
02HumanRandomized controlled trialEfficacy outcome
In patients with mild to moderate Alzheimer's disease, Cerebrolysin 10 ml significantly improved cognition at week 24 versus placebo (P=0.038).
In plain wordsIn patients with Alzheimer's disease, Cerebrolysin 10 ml improved cognition at week 24 compared with placebo.
Peptide
Cerebrolysin
Outcome
IncreaseADAS-cog at week 24
Study
n: not reported in source
Comparator
Placebo
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
10 ml · iv infusion · 12 weeksAs given in this study (human).
Measurements
P value for ADAS-cog cognitive performance
0.038 p value
Cerebrolysin 10 ml versus placebo at week 24
Source sentences
Summary
At week 24, significant improvement of cognitive performance on the ADAS-cog (P=0.038) and global function (CIBIC+; P>0.001) was observed for the 10 ml dose.
4 context sentences(design, population, supporting numbers)
Title · context
A 24-week, double-blind, placebo-controlled study of three dosages of Cerebrolysin in patients with mild to moderate Alzheimer's disease.
Summary · context
The efficacy and safety of three dosages of Cere were investigated in this randomized, double-blind, placebo-controlled, study.
Summary · context
Patients received iv infusions of 10, 30, 60 ml Cere or placebo 5 days/week for the first 4 weeks and thereafter, two iv infusions per week for 8 weeks.
Summary · context
Effects on cognition and clinical global impressions were evaluated 4, 12 and 24 weeks after the beginning of the infusions using the CIBIC+ and the modified Alzheimer's Disease Assessment Scale (ADAS)-cog.
Report a problemFND-1642039201
03HumanRandomized controlled trialEfficacy outcome
In patients with Alzheimer's disease, Cerebrolysin 10 ml improved global function at week 24 versus placebo, reported as significant (P>0.001).
In plain wordsIn patients with Alzheimer's disease, Cerebrolysin 10 ml improved global function at week 24 compared with placebo.
Peptide
Cerebrolysin
Outcome
IncreaseCIBIC+ at week 24
Study
n: not reported in source
Comparator
Placebo
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
10 ml · iv infusion · 12 weeksAs given in this study (human).
Measurements
P value for CIBIC+ global function
> 0.001 p value
Cerebrolysin 10 ml versus placebo at week 24
Source sentences
Summary
At week 24, significant improvement of cognitive performance on the ADAS-cog (P=0.038) and global function (CIBIC+; P>0.001) was observed for the 10 ml dose.
3 context sentences(design, population, supporting numbers)
Summary · context
The efficacy and safety of three dosages of Cere were investigated in this randomized, double-blind, placebo-controlled, study.
Summary · context
Patients received iv infusions of 10, 30, 60 ml Cere or placebo 5 days/week for the first 4 weeks and thereafter, two iv infusions per week for 8 weeks.
Summary · context
Effects on cognition and clinical global impressions were evaluated 4, 12 and 24 weeks after the beginning of the infusions using the CIBIC+ and the modified Alzheimer's Disease Assessment Scale (ADAS)-cog.
Report a problemFND-1642039202
04HumanRandomized controlled trialEfficacy outcome
In patients with Alzheimer's disease, Cerebrolysin 30 ml significantly improved global outcome versus placebo.
In plain wordsIn patients with Alzheimer's disease, Cerebrolysin 30 ml improved global outcome compared with placebo.
Peptide
Cerebrolysin
Outcome
IncreaseGlobal outcome
Study
n: not reported in source
Comparator
Placebo
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
30 ml · iv infusion · 12 weeksAs given in this study (human).
Source sentences
Summary
The 30 and 60 ml doses showed significant improvement of the global outcome but failed to show significant improvement of cognition.
3 context sentences(design, population, supporting numbers)
Summary · context
The efficacy and safety of three dosages of Cere were investigated in this randomized, double-blind, placebo-controlled, study.
Summary · context
Patients received iv infusions of 10, 30, 60 ml Cere or placebo 5 days/week for the first 4 weeks and thereafter, two iv infusions per week for 8 weeks.
Summary · context
Effects on cognition and clinical global impressions were evaluated 4, 12 and 24 weeks after the beginning of the infusions using the CIBIC+ and the modified Alzheimer's Disease Assessment Scale (ADAS)-cog.
Report a problemFND-1642039203
05HumanRandomized controlled trialEfficacy outcome
In patients with Alzheimer's disease, Cerebrolysin 30 ml did not significantly improve cognition versus placebo.
In plain wordsIn patients with Alzheimer's disease, Cerebrolysin 30 ml did not significantly improve cognition compared with placebo.
Peptide
Cerebrolysin
Outcome
No significant changeCognition
Study
n: not reported in source
Comparator
Placebo
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
30 ml · iv infusion · 12 weeksAs given in this study (human).
Source sentences
Summary
The 30 and 60 ml doses showed significant improvement of the global outcome but failed to show significant improvement of cognition.
3 context sentences(design, population, supporting numbers)
Summary · context
The efficacy and safety of three dosages of Cere were investigated in this randomized, double-blind, placebo-controlled, study.
Summary · context
Patients received iv infusions of 10, 30, 60 ml Cere or placebo 5 days/week for the first 4 weeks and thereafter, two iv infusions per week for 8 weeks.
Summary · context
Effects on cognition and clinical global impressions were evaluated 4, 12 and 24 weeks after the beginning of the infusions using the CIBIC+ and the modified Alzheimer's Disease Assessment Scale (ADAS)-cog.
Report a problemFND-1642039204
06HumanRandomized controlled trialEfficacy outcome
In patients with Alzheimer's disease, Cerebrolysin 60 ml significantly improved global outcome versus placebo.
In plain wordsIn patients with Alzheimer's disease, Cerebrolysin 60 ml improved global outcome compared with placebo.
Peptide
Cerebrolysin
Outcome
IncreaseGlobal outcome
Study
n: not reported in source
Comparator
Placebo
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
60 ml · iv infusion · 12 weeksAs given in this study (human).
Source sentences
Summary
The 30 and 60 ml doses showed significant improvement of the global outcome but failed to show significant improvement of cognition.
3 context sentences(design, population, supporting numbers)
Summary · context
The efficacy and safety of three dosages of Cere were investigated in this randomized, double-blind, placebo-controlled, study.
Summary · context
Patients received iv infusions of 10, 30, 60 ml Cere or placebo 5 days/week for the first 4 weeks and thereafter, two iv infusions per week for 8 weeks.
Summary · context
Effects on cognition and clinical global impressions were evaluated 4, 12 and 24 weeks after the beginning of the infusions using the CIBIC+ and the modified Alzheimer's Disease Assessment Scale (ADAS)-cog.
Report a problemFND-1642039205
07HumanRandomized controlled trialEfficacy outcome
In patients with Alzheimer's disease, Cerebrolysin 60 ml did not significantly improve cognition versus placebo.
In plain wordsIn patients with Alzheimer's disease, Cerebrolysin 60 ml did not significantly improve cognition compared with placebo.
Peptide
Cerebrolysin
Outcome
No significant changeCognition
Study
n: not reported in source
Comparator
Placebo
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
60 ml · iv infusion · 12 weeksAs given in this study (human).
Source sentences
Summary
The 30 and 60 ml doses showed significant improvement of the global outcome but failed to show significant improvement of cognition.
3 context sentences(design, population, supporting numbers)
Summary · context
The efficacy and safety of three dosages of Cere were investigated in this randomized, double-blind, placebo-controlled, study.
Summary · context
Patients received iv infusions of 10, 30, 60 ml Cere or placebo 5 days/week for the first 4 weeks and thereafter, two iv infusions per week for 8 weeks.
Summary · context
Effects on cognition and clinical global impressions were evaluated 4, 12 and 24 weeks after the beginning of the infusions using the CIBIC+ and the modified Alzheimer's Disease Assessment Scale (ADAS)-cog.
Report a problemFND-1642039206

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 stopped early · source ClinicalTrials.gov (opens in a new tab)

WithdrawnPhase 4NCT01822951

Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)

Ever Neuro Pharma GmbHn = 0Completion est. Dec 2016

Alzheimer Disease

Trial page ClinicalTrials.govUpdated 26 Oct 2015

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

Subjects

Terms as the source lists them.

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