Background: Cerebrolysin is a peptide preparation acting like endogenous neurotrophic factors. The aim of this study was to assess Cerebrolysin in patients suffering from vascular dementia. Methods: The combined outcome of ADAS-cog+ and CIBIC+ was assessed 24 weeks after baseline. 20ml IV Cerebrolysin were given OD in the course of two treatment-cycles as add-on therapy to basic treatment with acetylsalicylic acid. Results: Of 242 patients randomized a total of 217 (89.7%) completed the study. The therapy with Cerebrolysin resulted in significant improvement of both primary parameters. At week 24, cognition (ADAS-cog+) improved by -10,628 points in the Cerebrolysin group (LS mean difference -6.17; p<.0001 vs. placebo) and the overall clinical functioning (CIBIC+) showed a mean difference of -0.84 (p<.0001 vs. placebo). These findings were confirmed by responder analyses with higher rates in the Cerebrolysin group (ADAS-cog+ improvement of ≥4 points from baseline: 82.1% vs. 52.2%; CIBIC+ score of <4 at week 24: 75.2% vs. 37.4%; combined response in ADAS-cog+ and CIBIC+: 67.5% vs. 27.0). For Cerebrolysin, the odds ratios for achieving a favourable CIBIC+ response was 5.081 (p<0.05) and 5.633 (p<0.05) for the combined response. Cerebrolysin was significantly superior over placebo also in the MMSE, the activities of daily living (ADCS-ADL) and in the executive function (Trail-making test, Clock-drawing test). Conclusions: Cerebrolysin significantly improved the clinical outcome and these benefits lasted for at least six months. Cerebrolysin was safe and well tolerated.
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