Cerebrolysin in mild-to-moderate Alzheimer's Disease: a meta-analysis of randomized controlled clinical trials

Objective: The aim of this study was to provide a systematic and quantitative summary of benefit and risk of Cerebrolysin in patients with mild-to-moderate Alzheimer's disease (AD) and to avoid major deficiencies of an earlier meta-analysis. Design: This is a meta-analysis of randomized double-...

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Hauptverfasser: Gauthier, Serge (VerfasserIn) , Frölich, Lutz (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: March 26, 2015
In: Dementia and geriatric cognitive disorders
Year: 2015, Jahrgang: 39, Heft: 5/6, Pages: 332-347
ISSN:1421-9824
DOI:10.1159/000377672
Online-Zugang:Verlag, Volltext: http://dx.doi.org/10.1159/000377672
Verlag, Volltext: http://www.karger.com.ezproxy.medma.uni-heidelberg.de/Article/Abstract/377672
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Verfasserangaben:Serge Gauthier, Jefferson Voltaire Proaño, Jianping Jia, Lutz Froelich, Johannes Christophe Vester, Edith Doppler

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520 |a Objective: The aim of this study was to provide a systematic and quantitative summary of benefit and risk of Cerebrolysin in patients with mild-to-moderate Alzheimer's disease (AD) and to avoid major deficiencies of an earlier meta-analysis. Design: This is a meta-analysis of randomized double-blind placebo-controlled clinical trials. Data Sources: Trials were identified with the help of PubMed, the Cochrane Dementia Group database, the Center for Collaborative Neurosciences, and references from reviews; no language restrictions were applied. Study Selection: All randomized double-blind placebo-controlled studies on 30 ml/day of Cerebrolysin in mild-to-moderate AD were included. Results: There were 6 eligible randomized controlled trials comparing Cerebrolysin with placebo. For all studies, either individual patient data and/or published data (aggregate data) were available. Analyses were based on the odds ratio (OR) for dichotomized global clinical change and for safety criteria, on the standardized mean difference (SMD) for pooling of cognitive function, and on the Mann-Whitney statistic (MW) for multivariate analysis of ‘global benefit' (combined effect of global clinical change and cognitive function). Cerebrolysin was significantly more effective than placebo at 4 weeks regarding cognitive function (4 weeks: SMD -0.40 points; 95% CI -0.66 to -0.13; p = 0.0031; 6 months: SMD -0.37 points; 95% CI -0.90 to 0.16; p = 0.1710), at 4 weeks and 6 months regarding global clinical change (4 weeks: OR 3.32; 95% CI 1.20-9.21; p = 0.0212; 6 months: OR 4.98; 95% CI 1.37-18.13; p = 0.0150), and at 4 weeks and 6 months regarding ‘global benefit' (combined efficacy criteria; 4 weeks: MW 0.57, 95% CI 0.53-0.61; p = 0.0006; 6 months: MW 0.57; 95% CI 0.53-0.61; p = 0.0010). The safety aspects of Cerebrolysin were comparable to placebo. Conclusion: This meta-analysis provides evidence that Cerebrolysin has an overall beneficial effect and a favorable benefit-risk ratio in patients with mild-to-moderate AD. Cerebrolysin as a therapeutic agent should be considered by clinicians seeking treatment options for mild-to-moderate AD. 
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