Study summary · research use only
Cerebrolysin in mild-to-moderate Alzheimer's disease: a meta-analysis of randomized controlled clinical trials
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This meta-analysis summarized benefit and risk of Cerebrolysin in patients with mild-to-moderate Alzheimer's disease (AD), pooling randomized double-blind placebo-controlled trials of 30 ml/day Cerebrolysin. The abstract reports 6 eligible trials and analyses using odds ratios, standardized mean differences (SMD), and the Mann-Whitney statistic. It states Cerebrolysin differed significantly from placebo at 4 weeks for cognitive function (SMD -0.40; 95% CI -0.66 to -0.13; p=0.0031), at 4 weeks and 6 months for global clinical change (OR 3.32 and 4.98), and for combined 'global benefit' (MW 0.57), with safety comparable to placebo. The authors describe an overall beneficial effect and favorable benefit-risk ratio.
Abstract
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. This is a meta-analysis of randomized double-blind placebo-controlled clinical trials. 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. All randomized double-blind placebo-controlled studies on 30 ml/day of Cerebrolysin in mild-to-moderate AD were included. 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. 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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