To compare the efficacy and safety between domestic and imported donepezil hydrochloride tablets for mild-moderate Alzheimer's disease.

Clinical data of 250 patients with mild-moderate Alzheimer's disease were analyzed. The patients were randomly divided into experimental group (n=125, receiving domestic donepezil) and control group (n=125, receiving imported donepezil). The efficacy and adverse reactions between groups were analyzed by 4 aspects including cognitive ability, general impression, daily activities and behavioral and psychological symptoms before and 1, 3, 6 months after treatment.

There was no significant difference in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) scale in control group before versus 1 month after treatment, and in experimental group before versus 6 after treatment. There were no significant differences in Clinical Dementia Rating (CDR) scores in both groups between before and 1, 3, 6 months after treatment. The mini-mental state examination (MMSE), Montreal cognitive assessment (MOCA), cognitive part of the Alzheimer's Disease Assessment Scale (ADAS-cog), Neuropsychiatric Inventory (NPI-Q), Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus) and Hamilton Depression Scale (HAMD) were improved in the two group after treatment as compared before treatment (all P<0.05). There were no differences in the changes in cognition, function, behavior and global assessments between the two groups after 1, 3, 6 months of treatment (all P>0.05). The adverse reaction rate had no difference between the two groups (P>0.05).

The efficacy and safety between equal-dose domestic and imported donepezil hydrochloride tablets are the same in treating mild-moderate Alzheimer's disease.

Alzheimer's disease; Cholinesterase inhibitors; Neuropsychological tests