Efficacy and safety of a transdermal donepezil patch in patients with mild-to-moderate Alzheimer's disease: A 24-week, randomized, multicenter, double-blind, parallel group, non-inferiority study

Aim: To assess non-inferiority of a donepezil patch 27.5 mg compared with donepezil hydrochloride tablets 5 mg in patients with mild-to-moderate Alzheimer's disease; and to compare the efficacy and safety profiles of a donepezil patch 27.5 mg with donepezil hydro-chloride tablets 5 mg.Methods: This was a 24-week, multicenter, randomized, double-blind, double-dummy, parallel group, non-inferiority (phase III) study carried out in Japan. The primary end-point was the change in the Alzheimer's Disease Assessment Scale-cognitive component-Japanese version from baseline to week 24, with the aim of evaluating the non-inferiority of the done-pezil patch 27.5 mg compared with donepezil hydrochloride tablets 5 mg.Results: Of 340 randomized patients, 303 completed the double-blind period. Changes from baseline in the Alzheimer's Disease Assessment Scale-cognitive component-Japanese version at week 24 (least squares mean + standard error) were-0.7 + 0.4 (donepezil patch 27.5 mg) and 0.2 + 0.4 (donepezil hydrochloride tablet 5 mg). The difference in the least squares means (95% confidence interval) was-0.9 (-2.01 to 0.14). The upper bound of the 95% confidence interval for the difference between groups was less than the predefined non-inferiority margin of 2.15. The donepezil patches 27.5 mg also had a safety profile that showed good tolerability comparable with donepezil hydrochloride tablets 5 mg. Conclusions: Non-inferiority on suppression of cognitive decline was shown for the done-pezil patch 27.5 mg when compared with donepezil hydrochloride tablets 5 mg in Japanese patients with mild-to-moderate Alzheimer's disease. Geriatr Gerontol Int 2023; center dot center dot: center dot center dot-center dot center dot.