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Randomized Controlled Trial Multicenter Study
Donepezil decreases annual rate of hippocampal atrophy in suspected prodromal Alzheimer's disease.
- Bruno Dubois, Marie Chupin, Harald Hampel, Simone Lista, Enrica Cavedo, Bernard Croisile, Guy Louis Tisserand, Jacques Touchon, Alain Bonafe, Pierre Jean Ousset, Amir Ait Ameur, Olivier Rouaud, Fréderic Ricolfi, Alain Vighetto, Florence Pasquier, Christine Delmaire, Mathieu Ceccaldi, Nadine Girard, Carole Dufouil, Stéphane Lehericy, Isabelle Tonelli, Françoise Duveau, Olivier Colliot, Line Garnero, Marie Sarazin, Didier Dormont, “Hippocampus Study Group”, and Hippocampus Study Group.
- Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A), Département de Neurologie, Hôpital de la Pitié-Salpêtrière, AP-HP, Paris, France; INSERM, CNRS, UMR-S975, Institut du Cerveau et de la Moelle Epinière (ICM), Paris, France; Sorbonne Universités, Université Pierre et Marie Curie-Paris 6, Paris, France. Electronic address: bruno.dubois@psl.aphp.fr.
- Alzheimers Dement. 2015 Sep 1; 11 (9): 1041-9.
IntroductionThe purpose of this study was to study the effect of donepezil on the rate of hippocampal atrophy in prodromal Alzheimer's disease (AD).MethodsA 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.ResultsTwo-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.DiscussionA 45% reduction of rate of hippocampal atrophy was observed in prodromal AD following 1 year of treatment with donepezil compared with placebo.Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.
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