[Clinical efficacy and safety of akatinol memantine in treatment of mild to moderate Alzheimer disease: a donepezil-controlled, randomized trial].

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OBJECTIVE: To evaluate the clinical efficacy and safety of akatinol memantine in the treatment of patients with mild to moderate Alzheimer disease (AD). METHODS: One hundred patients with diagnosis of possible or probable AD and Mini Mental State Examination total scores between 10 and 26 from 6 centers in two cities of China were randomly divided into two groups: akatinol memantine group (n = 50, given akatinol memantine 5 mg/d in first week, 10 mg/d in second week, 15 mg/d in third week and 20 mg/d from fourth to sixteenth week); donepezil group (n = 50, donepezil 5 mg/d). Different scales were used to evaluated cognitive function (MMSE), activity of daily life and behavior and mood (Blessed-Roth scale) as well as the severity of dementia (GDS). Safety evaluation was conducted every 4 weeks. RESULTS: In comparison with the baseline data, there were significant improvements in cognition assessed with MMSE on 16th week in akatinol memantine group (P = 0.000) and donepezil group (P = 0.000) respectively; There also were significant improvements in activity of daily life, behavior and mood assessed by Blessed-Roth scale in akatinol memantine group (P = 0.000) and donepezil group (P = 0.000) on 8th week and 16th week. However there was no improvements in the change of the basic habit of life assessed with the Part II of Blessed-Roth scale (P > 0.05), and nor an improvements in the serious level of dementia assessed with GDS (P > 0.05). In comparison with the data in donepezil group, there were no improvement in the change of MMSE score, Blessed-Roth scale score and GDS score in akatinol memantine group on 16th week (P > 0.05). Mild and transient adverse events were observed in 6% of akatinol memantine group. CONCLUSION: As a safe and effective medicine, akatinol memantine, which has a similar effect as donepezil for AD, can remarkably improve the cognition, behavior, and mood of AD patients.

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