title: Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials.
abstract: 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.
  
  
  METHODS
  This is a meta-analysis of randomized double-blind placebo-controlled clinical trials.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: McGill Center for Studies in Aging, Montreal, Que., Canada.
authors.forename: Serge
authors.initials: S
authors.lastname: Gauthier
authors.forename: Jefferson Voltaire
authors.initials: JV
authors.lastname: Proaño
authors.forename: Jianping
authors.initials: J
authors.lastname: Jia
authors.forename: Lutz
authors.initials: L
authors.lastname: Froelich
authors.forename: Johannes Christophe
authors.initials: JC
authors.lastname: Vester
authors.forename: Edith
authors.initials: E
authors.lastname: Doppler
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D000596:Amino Acids / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects; D006801:Humans; D018697:Nootropic Agents / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000596:Amino Acids; D018697:Nootropic Agents; C006952:cerebrolysin