Memantine treatment in Alzheimer disease:a randomized double-blind controlled trial

AIM To evaluate the efficacy and safety of memantine hydrochloride in the treatment of patients with Alzheimer's disease(AD).METHODS The study was designed as a randomized,double blind,double-dummy,active control trial with flexible dosage.Fifty-eight AD patients were randomly assigned into memantine group(5-20 mg·d-1,po,qd)or donepezil group(5-10 mg·d-1,po,qd).The treatment lasted for 16 wk.At baseline and every 4 wk the patients were assessed by mini-mental state examination(MMSE),activity of daily living scale(ADL), clinical global impression(CGI) global improvement and treatment emergent symptom scale(TESS).RESULTS The MMSE scores increased mildly in both treatment groups.After 12 wk and 16wk treatment,MMSE scores increased significantly compared with baseline(P0.01) in both groups.There was no significant difference in the increasing MMSE scores between 2 groups(P0.05).No significant difference in CGI improvement was found between 2 groups(P0.05).ADL scores in each group didn't change significantly(P0.05).One patient(3.4%) in memantine group was reported on mild dizziness,while 6(20.7%) patients taking donepezil was reported on nausea,losing appetite or overexcitement.The rate of adverse drug reaction(ADR) was significantly lower in memantine group than that in donepezil group(P0.05).CONCLUSION Memantine is useful to improve or stabilize the cognitive function of AD patients as donepezil.The ADR rate of memantine is rare so it is safe.