Alzheimer's & dementia : the journal of the Alzheimer's Association · 2015
Donepezil decreases annual rate of hippocampal atrophy in suspected prodromal Alzheimer's disease.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Dubois Bruno, Chupin Marie, Hampel Harald, Lista Simone, Cavedo Enrica, Croisile Bernard, Louis Tisserand Guy, Touchon Jacques, Bonafe Alain, Ousset Pierre Jean, Ait Ameur Amir, Rouaud Olivier, Ricolfi Fréderic, Vighetto Alain, Pasquier Florence, Delmaire Christine, Ceccaldi Mathieu, Girard Nadine, Dufouil Carole, Lehericy Stéphane, Tonelli Isabelle, Duveau Françoise, Colliot Olivier, Garnero Line, Sarazin Marie, Dormont Didier, “Hippocampus Study Group”, Hippocampus Study Group
Аннотация
INTRODUCTION: The purpose of this study was to study the effect of donepezil on the rate of hippocampal atrophy in prodromal Alzheimer's disease (AD).
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.
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%), P < .001. There was no significant difference in neuropsychological performance between treatment groups.
DISCUSSION: A 45% reduction of rate of hippocampal atrophy was observed in prodromal AD following 1 year of treatment with donepezil compared with placebo.
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.
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%), P < .001. There was no significant difference in neuropsychological performance between treatment groups.
DISCUSSION: A 45% reduction of rate of hippocampal atrophy was observed in prodromal AD following 1 year of treatment with donepezil compared with placebo.