Combination treatment in Alzheimer's disease: results of a randomized, controlled trial with cerebrolysin and donepezil.

Alvarez XA, Cacabelos R, Sampedro C, Couceiro V, Aleixandre M, Vargas M, Linares C, Granizo E, García-Fantini M, Baurecht W, Doppler E, Moessler H

Current Alzheimer research1 Aug 2011Cited by 38 (Europe PMC)

PMID21679156DOI10.2174/156720511796391863PepBankPUB-21679156

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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 study14

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Alzheimer's disease, cognitive effects did not differ significantly between Cerebrolysin plus donepezil and donepezil alone.
In plain wordsIn Alzheimer's disease, cognitive effects did not differ significantly between Cerebrolysin plus donepezil and donepezil alone.
Peptide
Cerebrolysin
Outcome
No significant changeCombination cognitive treatment effects
Study
n = 133
Comparator
Donepezil alone
Analysis
Primary
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
10 mlAs given in this study (human).
Measurements
Mean change in cognitive performance
−2.3
Cerebrolysin plus donepezil
SD of change in cognitive performance
6
Cerebrolysin plus donepezil
Mean change in cognitive performance
−1.2
Donepezil alone
SD of change in cognitive performance
6.1
Donepezil alone
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
Summary
Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: -2.3±6.0) with best scores in the combined therapy group at all study visits.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
Report a problemFND-2167915602
02HumanRandomized controlled trialEfficacy outcome
In mild-to-moderate Alzheimer's disease, global outcome improvements favored Cerebrolysin plus donepezil over donepezil alone.
In plain wordsIn Alzheimer's disease, Cerebrolysin plus donepezil improved global outcome more than donepezil alone.
Peptide
Cerebrolysin
Outcome
IncreaseCombination global outcome
Study
n = 133
Comparator
Donepezil alone
Analysis
Primary
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
10 mlAs given in this study (human).
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
Report a problemFND-2167915611
03HumanRandomized controlled trialEfficacy outcome
In mild-to-moderate Alzheimer's disease, cognitive treatment effects did not differ significantly between Cerebrolysin alone and donepezil alone.
In plain wordsIn mild-to-moderate Alzheimer's disease, cognitive effects did not differ significantly between Cerebrolysin alone and donepezil alone.
Peptide
Cerebrolysin
Outcome
No significant changeCognitive treatment effects
Study
n = 130
Comparator
Donepezil
Analysis
Primary
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
10 mlAs given in this study (human).
Measurements
Mean change in cognitive performance
−1.7
Cerebrolysin alone
SD of change in cognitive performance
7.5
Cerebrolysin alone
Mean change in cognitive performance
−1.2
Donepezil alone
SD of change in cognitive performance
6.1
Donepezil alone
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
Summary
Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: -2.3±6.0) with best scores in the combined therapy group at all study visits.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
Report a problemFND-2167915607
04HumanRandomized controlled trialEfficacy outcome
In mild-to-moderate Alzheimer's disease, global outcome improvements favored Cerebrolysin over donepezil.
In plain wordsIn Alzheimer's disease, global outcome improvements favored Cerebrolysin over donepezil.
Peptide
Cerebrolysin
Outcome
IncreaseGlobal outcome
Study
n = 130
Comparator
Donepezil
Analysis
Primary
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
10 mlAs given in this study (human).
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
Report a problemFND-2167915610
05HumanRandomized controlled trialEfficacy outcome
In mild-to-moderate Alzheimer's disease, cognitive performance improved in all groups, including Cerebrolysin, with mean change -1.7±7.5.
In plain wordsIn Alzheimer's disease, cognition improved from baseline in all groups, including Cerebrolysin.
Peptide
Cerebrolysin
Outcome
DecreaseCognitive change from baseline
Study
n = 64
Analysis
Primary
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
10 mlAs given in this study (human).
Measurements
Mean change in cognitive performance
−1.7
Cerebrolysin 10 ml
SD of change in cognitive performance
7.5
Cerebrolysin 10 ml
Source sentences
Summary
Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: -2.3±6.0) with best scores in the combined therapy group at all study visits.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
Report a problemFND-2167915612
06HumanRandomized controlled trialEfficacy outcome
In Alzheimer's disease, functional effects did not differ significantly between Cerebrolysin plus donepezil and donepezil alone.
In plain wordsIn Alzheimer's disease, functional effects did not differ significantly between Cerebrolysin plus donepezil and donepezil alone.
Peptide
Cerebrolysin
Outcome
No significant changeCombination functional treatment effects
Study
n = 133
Comparator
Donepezil alone
Analysis
Secondary
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
10 mlAs given in this study (human).
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
Report a problemFND-2167915604
07HumanRandomized controlled trialEfficacy outcome
In Alzheimer's disease, behavioral effects did not differ significantly between Cerebrolysin plus donepezil and donepezil alone.
In plain wordsIn Alzheimer's disease, behavioral effects did not differ significantly between Cerebrolysin plus donepezil and donepezil alone.
Peptide
Cerebrolysin
Outcome
No significant changeCombination behavioral treatment effects
Study
n = 133
Comparator
Donepezil alone
Analysis
Secondary
Outcome group
Psychiatric symptoms · Mental health and mood
Studied dose
10 mlAs given in this study (human).
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
Report a problemFND-2167915606
08HumanRandomized controlled trialEfficacy outcome
In mild-to-moderate Alzheimer's disease, functional treatment effects did not differ significantly between Cerebrolysin alone and donepezil alone.
In plain wordsIn mild-to-moderate Alzheimer's disease, functional effects did not differ significantly between Cerebrolysin alone and donepezil alone.
Peptide
Cerebrolysin
Outcome
No significant changeFunctional treatment effects
Study
n = 130
Comparator
Donepezil
Analysis
Secondary
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
10 mlAs given in this study (human).
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
Report a problemFND-2167915608
09HumanRandomized controlled trialEfficacy outcome
In mild-to-moderate Alzheimer's disease, behavioral treatment effects did not differ significantly between Cerebrolysin alone and donepezil alone.
In plain wordsIn mild-to-moderate Alzheimer's disease, behavioral effects did not differ significantly between Cerebrolysin alone and donepezil alone.
Peptide
Cerebrolysin
Outcome
No significant changeBehavioral treatment effects
Study
n = 130
Comparator
Donepezil
Analysis
Secondary
Outcome group
Psychiatric symptoms · Mental health and mood
Studied dose
10 mlAs given in this study (human).
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
Report a problemFND-2167915609

Studies that did not test the peptide alone5

In this study, Cerebrolysin was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Cerebrolysin.

10HumanNot a test of Cerebrolysin aloneRandomized controlled trialEfficacy outcome
In Alzheimer's disease, cognitive effects did not differ significantly between Cerebrolysin plus donepezil and Cerebrolysin alone.
In plain wordsIn Alzheimer's disease, cognitive effects did not differ significantly between Cerebrolysin plus donepezil and Cerebrolysin alone.
Peptide
Cerebrolysin
Outcome
No significant changeCombination cognitive treatment effects
Study
n = 131
Comparator
Cerebrolysin alone
Analysis
Primary
Outcome group
Cognition and memory · Nervous system and cognition
Measurements
Mean change in cognitive performance
−2.3
Cerebrolysin plus donepezil
SD of change in cognitive performance
6
Cerebrolysin plus donepezil
Mean change in cognitive performance
−1.7
Cerebrolysin alone
SD of change in cognitive performance
7.5
Cerebrolysin alone
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
Summary
Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: -2.3±6.0) with best scores in the combined therapy group at all study visits.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
In this study, Cerebrolysin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Cerebrolysin.
Report a problemFND-2167915601
11HumanNot a test of Cerebrolysin aloneRandomized controlled trialEfficacy outcome
In mild-to-moderate Alzheimer's disease, cognition improved in all groups, with mean change -2.3±6.0 for Cerebrolysin plus donepezil.
In plain wordsIn Alzheimer's disease, cognition improved from baseline in all groups, including Cerebrolysin plus donepezil.
Peptide
Cerebrolysin
Outcome
DecreaseCombination cognitive change
Study
n = 67
Analysis
Primary
Outcome group
Cognition and memory · Nervous system and cognition
Measurements
Mean change in cognitive performance
−2.3
Cerebrolysin plus donepezil
SD of change in cognitive performance
6
Cerebrolysin plus donepezil
Source sentences
Summary
Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: -2.3±6.0) with best scores in the combined therapy group at all study visits.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
In this study, Cerebrolysin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Cerebrolysin.
Report a problemFND-2167915613
12HumanNot a test of Cerebrolysin aloneRandomized controlled trialEfficacy outcome
In Alzheimer's disease, functional effects did not differ significantly between Cerebrolysin plus donepezil and Cerebrolysin alone.
In plain wordsIn Alzheimer's disease, functional effects did not differ significantly between Cerebrolysin plus donepezil and Cerebrolysin alone.
Peptide
Cerebrolysin
Outcome
No significant changeCombination functional treatment effects
Study
n = 131
Comparator
Cerebrolysin alone
Analysis
Secondary
Outcome group
Exercise and physical function · Nervous system and cognition
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
In this study, Cerebrolysin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Cerebrolysin.
Report a problemFND-2167915603
13HumanNot a test of Cerebrolysin aloneRandomized controlled trialEfficacy outcome
In Alzheimer's disease, behavioral effects did not differ significantly between Cerebrolysin plus donepezil and Cerebrolysin alone.
In plain wordsIn Alzheimer's disease, behavioral effects did not differ significantly between Cerebrolysin plus donepezil and Cerebrolysin alone.
Peptide
Cerebrolysin
Outcome
No significant changeCombination behavioral treatment effects
Study
n = 131
Comparator
Cerebrolysin alone
Analysis
Secondary
Outcome group
Psychiatric symptoms · Mental health and mood
Source sentences
Summary
Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
In this study, Cerebrolysin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Cerebrolysin.
Report a problemFND-2167915605
14HumanNot a test of Cerebrolysin aloneRandomized controlled trialSafety outcome
In mild-to-moderate Alzheimer's disease, the study reported Cerebrolysin plus donepezil as safe.
In plain wordsIn Alzheimer's disease, the study reported Cerebrolysin plus donepezil as safe.
Peptide
Cerebrolysin
Outcome
Not applicableCombination safety
Study
n = 67
Outcome group
Adverse events · Whole body
Source sentences
Summary
Cerebrolysin was as effective as donepezil, and the combination of neurotrophic (Cerebrolysin) and cholinergic (donepezil) treatment was safe in mild-to-moderate AD.
1 context sentence(design, population, supporting numbers)
Summary · context
We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial.
In this study, Cerebrolysin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Cerebrolysin.
Report a problemFND-2167915616

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 2Results postedNCT00911807

Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease

Ever Neuro Pharma GmbHn = 217Oct 2004 to Apr 2008

Alzheimer Disease

Trial page ClinicalTrials.govUpdated 10 Jun 2009

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.

Publication types

MeSH terms

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