Objective: To explore the potential differing effects of 2 acetylcholinesterase inhibitors (AChEIs), galantamine and donepezil, on sleep, attention, and gastrointestinal side effects, as well as methodologies for measuring these effects, in patients with mild-to-moderate Alzheimer’s disease (AD).
Design: A double-blind, multicenter pilot study was conducted, with 1:1 randomization to 2 treatment arms with a 3-times-daily dosing schedule used to ensure blinding. Following a 2-week, single-blind, run-in phase, 90 subjects were randomized into a double-blind assessment phase with galantamine 16 mg/day (8 mg bid plus placebo qhs) or donepezil 10 mg/day (10 mg qhs with placebo bid) to reach a target of at least 60 patients completing the trial and all its assessments. The double-blind assessment phase continued for 8 weeks, followed by an extension phase of 6 to 32 weeks, which allowed patients to continue their assigned treatment until the randomization code was unblinded.
Materials and Methods: No standardized method has been adopted for assessing sleep and attention in patients with AD. In this study, sleep disturbances were measured primarily by actigraphy (wrist-worn watch-type device that records motion), a sleep log, and a questionnaire on sleep quality. Sleep disturbances were also measured in caregivers. Multiple measures were used to assess attention deficits, including the Choice Reaction Time/Simple Reaction Time in the Cognitive Drug Research Computerized Assessment for Demented Patients, the Stroop Word Color Test, and the Verbal Series Attention Test. Conventional efficacy measures, including outcomes instruments, and adverse event reporting were used to evaluate efficacy and tolerability.
Results: Clinical results will be presented.
Conclusion: Although previous head-to-head studies comparing AChEIs have been presented, all of these studies have been open-label trials with blinded raters. This is the first true double-blind comparison between AChEIs.
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