Efficacy of FPF 1070 (cerebrolysin) in patients with Alzheimer's disease -A multicentre, randomised, double-blind, placebo-controlled trial

Objective: This study evaluated the efficacy and tolerability of FPF 1070 ( cerebrolysin) in patients with mild to moderately severe Alzheimer's diseas e (AD). Methods: The trial was of a multicentre, double-blind, parallel-group desig n. 157 patients aged 55 to 85 years were randomised to treatment with eithe r FPF 1070 30ml or placebo intravenous infusion once daily from Monday to F riday for 4 weeks. The results were assessed with scales including the Mini -Mental Status Examination (MMSE), Clinical Global Impression, Sandoz Clini cal Assessment-Geriatric (SCAG), Hamilton Depression Scale, Nuremberg Activ ities Inventory (NAI), Activities of Daily Living, acid the modified Trail Making Test (ZVT). Results: Patients treated with FPF 1070 demonstrated statistically signific ant (p < 0.05 or p < 0.01) improvements in MMSE, SCAG and NAI scores and in the ZVT test at the end-point of treatment compared with patients treated with placebo. The MMSE score was increased by an average of 2.5 points in p atients treated with FPF 1070 compared with the baseline MMSE score. The in cidence of treatment-emergent adverse events with FPF 1070 (8%) was very lo w and comparable with that observed with placebo (2%). Conclusion: FPF 1070 produced clinically relevant improvements in cognitive function, non-cognitive psychiatric symptoms and daily activity in patient s with AD. No significant adverse effects were observed during treatment wi th FPF 1070.