CREGS - Results of a large high-quality comparative effectiveness study

Prof. Brainin presented the newly published CREGS study – a large, prospective, multinational, high-quality registry study investigating the real-world effectiveness of Cerebrolysin in patients with moderate acute ischemic stroke (NIHSS 8-15).

The study, conducted across 16 countries, followed methodological standards and included 1,865 patients. , A registry design was chosen over a randomized controlled trial to assess effectiveness in real clinical practice which has been the “missing link” in the overall clinical development of Cerebrolysin (und dann Gerald’s slide, closing the gap als Abbildung)

The median treatment dosage and treatment duration reflects everyday practice, with patients receiving 30 ml of Cerebrolysin for 10 days. The primary endpoint was the modified Rankin Scale (mRS) score at day 90 and the result showed that patients treated with Cerebrolysin improved their functional outcome significantly. Also, the proportion of patients reaching functional independence (mRS 0–2) and excellent recovery (mRS 0–1) are significantly higher. Cognitive outcomes revealed particularly interesting findings. In patients who were assessed by IQCODE with pre-stroke cognitive decline, Cerebrolysin appeared to stabilize cognitive function, as shown by MoCA scores at day 90.

Further analysis shows consistent benefits across both thrombolysis and non-thrombolysis subgroups, suggesting potential additive effects when combined with thrombolytic therapy. Importantly, Cerebrolysin is well tolerated, with no increase in serious adverse events or deaths compared to controls. Prof. Brainin summarised that the CREGS study demonstrates that Cerebrolysin is effective in real-world practice across multiple countries. It supports early and sustained functional recovery.

Finally, the ongoing CODEC-study is currently investigating Cerebrolysin’s effects on post-stroke cognitive decline using four treatment cycles and an extensive neuropsychological assessment battery. Prof. Brainin and the other investigators expect the results towards the end of next year and they are curious  to see if CODEC further confirms the promising findings from CREGS.