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The efficacy and safety of donepezil as a treatment for patients with mild to moderate Alzheimers disease(AD)was investigated in a multicenter, double-blind study.Patients were randomly assigned to treatment with placebo(n=162),5 mg/d donepezil(n=152),or 10 mg/d donepezil(n=157)for 24 weeks followed by a 6-week single-blind placebo washout.The primary efficacy measures were the cognitive portion of the Alzheimer's Disease Assessment Scale(ADAS-cog)and the Clinician's Interview Based Assessment of Change-Plus(CIBIC plus),with the Mini-Mental State Examination(MMSE), Clinical Dementia Rating Scale-Sum of Boxes(CDR-SB),and patient rated Quality of Life(QoL)used as secondary measures.Cognitive function,as measured by the ADAS-cog,was significantly improved in the 5-and 10-mg/d donepezil groups as compared with the placebo group at weeks 12,18,and 24. Clinician's global ratings on the CIBIC plus also improved both the 5-and 10-mg/d donepezil groups relative to placebo.At the end of the 6 week placebo washout phase,ADAS-cog scores and CIBIC plus ratings were not significantly different for the three groups.Significant treatment benefits were also observed consistency in both the 5-and 10-mg/d groups on the MMSE and the CDR-SB,but there was no consistent effect on the patient-rated QoL.Cholinergic side effects(primarily diarrhea,nausea,and vomiting)were reported more often in the 10-mg/d group than either the 5- mg/d or placebo groups.Side effects were transient and generally mild in severity.These data indicate that donepezil is a well-tolerated drug that improves cognition and global function in patients with mild to moderate AD. |
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