Multicenter controlled randomized clinical trial of akatinol memantine for treatment of Aizheimer's disease / 中华神经科杂志

ABSTRACT

Objective To evaluate the clinical efficacy and safety of akatinol memantine in the treatment of Alzheimer's disease (AD).Methods Two hundred and forty-one patients with AD were randomly assigned to receive 10 mg of donepezil daily or 20 mg of memantine daily for 24 weeks.The primary efficacy variables were the Clinician' s Interview-Based Impression of Change Plus (CIBIC-Plus),the Alzheimer Disease Assessment Scale-cognition (ADAS-cog) and the Activities of Daily Living (ADL).The secondary efficacy variables were the Neuropsychiatric Inventory (NPI) and the Mini-Mental Status Examination (MMSE).Results Two hundred and seven patients completed the study and were evaluated at week 24.Both memantine and donepezil had significant efficacies at the end point, according to the ADAS-cog, the ADL, the NPI and the MMSE.Patients receiving memantine had a similar outcome as those receiving donepezil, according to the results of all the variables changes (CIBIC-Plus memantine 3.4±0.8vs donepezil 3.5±0.8; ADAS-cog memantine-4.7±5.8 vs donepezil-4.6±6.5; ADL memantine -2.4±6.7 vs donepezil-2.2±5.3 ; NP1 memantine-5.8±9.0 vs donepezil-3.1±8.5 ; MMSEmemantine 1.7±3.1 vs donepezil 1.8±2.8, all P >0.05).The adverse events were as following donepezil group 41.88% and memanintine group 30.58%.Conclusion The memantine as a new drug for AD, has the similar efficacy as donepezil, and it is safe.