Objective: This study evaluated the efficacy and tolerability of FPF 1070 (cerebrolysin) in patients with mild to moderately severe Alzheimer's disease (AD). Methods: The trial was of a multicentre, double-blind, parallel-group design. 157 patients aged 55 to 85 years were randomised to treatment with either FPF 1070 30 ml or placebo intravenous infusion once daily from Monday to Friday for 4 weeks. The results were assessed with scales including the Mini-Mental Status Examination (MMSE), Clinical Global Impression, Sandoz Clinical Assessment-Geriatric (SCAG), Hamilton Depression Scale, Nuremberg Activities Inventory (NAI), Activities of Daily Living, and the modified Trail Making Test (ZVT). Results: Patients treated with FPF 1070 demonstrated statistically significant (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 patients treated with FPF 1070 compared with the baseline MMSE score. The incidence of treatment-emergent adverse events with FPF 1070 (8) was very low 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 patients with AD. No significant adverse effects were observed during treatment with FPF 1070.