ABSTRACT
Aim: To evaluate the efficacy and tolerability of MLC601 in patients with mild to moderate Alzheimer disease (AD). Study Design: This is an open-label pilot study. Place and Duration of Study: It was conducted at three university referral centres in Iran from September 2009 until November 2011. Methodology: One-hundred and twenty four outpatients with mild to moderate AD who had previously failed to tolerate or benefit from treatment with Rivastigmine for 6 months at a dose of 2 to 12 mg per day were switched to a MLC601 regimen of one capsule three times per day for up to 18 months. Outcome measures included adverse events (AEs), withdrawal rate, and changes in the Mini-Mental State Examination (MMSE) and the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements. Results: Two patients were lost to follow up, and 122 patients completed the 18-month trial. The mean age of the participants was 65.3±6.4 years (range 54-82), and 77 (63.1%) of the participants were female. Improved cognitive function was observed in the first 6 months of the regimen (ADAS-cog=-3.1±10.1; MMSE=1.2±3.0), and the stabilisation of cognitive decline was observed over the remaining 12 months (ADAScog=- 1.6±7.6; MMSE=0.8±4.2). AEs were predominantly gastrointestinal and occurred in 7.3% of patients. Conclusions: MLC601 showed good tolerability and promising effects on cognitive function in AD patients during 18 months of treatment.