Objectives: The efficacy of donepezil for the treatment of cognitive dysfuntion in Alzheimer's disease has been demonstrated. The objective [corrected] of this study was to evaluate the effectiveness of donepezil in different neuropsychological areas of mild or moderate AD patients over a period of twelve months compared with data from untreated patients (historical control).
Methods: This was an open-label study where 100 patients received donepezil 5mg or 10 mg/day for twelve months. Because the study was uncontrolled, data were compared with historical data from 81 patients who had not received anticholinesterase inhibitors. The CAMCOG neuropsychological battery was used in both groups at baseline and at month 12.
Results: A hundred patients (30% male and 70% female) were enrolled in the study receiving donepezil 5 or 10 mg/day (average age: 74.3 6.1 years). The historical control group consisted of 81 people (average age 72.9 6.5 years), 29.6% of whom were men. There were no significant differences with respect to age, sex and CAMCOG score at baseline. The differences within the groups were significant in the following neuropsychological areas: recent, remote and learning memory, attention, calculation and abstract verbal thinking. Differences in expressive language and learning memory between both groups were confirmed by the multivariative analysis of baseline.
Conclusion: The rate of cognitive deterioration observed in mild to moderate AD patients receiving open-label donepezil treatment was less than expected if this cohort had not been treated. The cognitive beneficial effects observed during one year treatment with donepezil were mainly focused on memory and verbal expression.