Th
e purpos
e of this study was to study th
e eff
ect of don
ep
ezil on th
e rat
e of hippocampal atrophy in prodromal Alzh
eim
er's dis
eas
e (AD).
ec_2">Methods
A double-blind, randomized, placebo-controlled parallel group design using donepezil (10 mg/day) in subjects with suspected prodromal AD. Subjects underwent two brain magnetic resonance imaging scans (baseline and final visit). The primary efficacy outcome was the annualized percentage change (APC) of total hippocampal volume (left + right) measured by an automated segmentation method.
ec_3">Results
Two-hundred and sixteen only subjects were randomized across 28 French expert clinical sites. In the per protocol population (placebo = 92 and donepezil = 82), the donepezil group exhibited a significant reduced rate of hippocampal atrophy (APC = −1.89%) compared with the placebo group (APC = −3.47%), <em>Pem> < .001. There was no significant difference in neuropsychological performance between treatment groups.
ec_4">Discussion
A 45% reduction of rate of hippocampal atrophy was observed in prodromal AD following 1 year of treatment with donepezil compared with placebo.