The clinical trial protocol of the Metrifonate in Alzheimer's Trial (MALT).

The promising results of early trials in Alzheimer's disease with the acetylcholinesterase inhibitor metrifonate prompted initiation of the Metrifonate in ALzheimer's Trial (MALT). MALT is an international, randomized, double-blind, placebo-controlled, parallel-group study which was designed to determine, over a 26-week period, the efficacy, tolerability and safety of two doses of metrifonate in patients with probable Alzheimer's disease. A total of 605 patients were randomized to receive either a daily dose of oral metrifonate 40/50 mg (n = 200, by body weight <65 kg/> or =65 kg) or metrifonate 60/80 mg (n = 197, by body weight <65 kg/> or = 65 kg). Patients were assessed in the key symptom domains of Alzheimer's disease, i.e. cognition, behavioural and psychiatric disturbances, activities of daily living and global function. In summary, administration of metrifonate for 26 weeks to the intent-to-treat population significantly benefited cognitive performance, global function and certain aspects of behaviour and functional ability compared with placebo. These efficacy results were associated with high levels of acetylcholinesterase inhibition and a good safety and tolerability profile. The protocol of MALT is discussed here. Full results of the study will be available in a separate publication.