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Table of Contents
Vol. 13, No. 3, 2002
Issue release date: March 2002
Dement Geriatr Cogn Disord 2002;13:183–192

Effects of Rivastigmine on Cognitive Function in Dementia with Lewy Bodies: A Randomised Placebo-Controlled International Study Using the Cognitive Drug Research Computerised Assessment System

Wesnes K.A. · McKeith I.G. · Ferrara R. · Emre M. · Del Ser T. · Spano P.F. · Cicin-Sain A. · Anand R. · Spiegel R.
aCognitive Drug Research Ltd, Reading, and bInstitute for the Health of the Elderly, University of Newcastle upon Tyne, UK; cNovartis Farma, Origgio, and dFacoltàdi Medicina e Chirurgia, Università degli studi Brescia, Italy, eIstanbul Medical School, Istanbul, Turkey; fSection of Neurology, Hospital Severo Ochoa, Leganes, Madrid, Spain; gNovartis Pharma AG, Basel, Switzerland; hNovartis Pharmaceuticals Corporation, Hannover, N.J., USA

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This study was designed to assess the effects of rivastigmine (Exelon®) on the cognitive functioning of patients suffering from dementia with Lewy bodies. This was a prospective, multi-centre, randomised, double-blind, placebo-controlled exploratory study conducted at sites in the UK, Spain and Italy. The treatment period was 20 weeks with a 3-week posttreatment follow-up. The primary outcome measures were the Cognitive Drug Research (CDR) computerised assessment system and the Neuropsychiatric Inventory. Testing was conducted prior to dosing and then again at weeks 12, 20 and 23. Analysis of the data from the 92 patients who completed the study identified a significant pattern of benefits of rivastigmine over placebo on the CDR system. These benefits were seen on tests of attention, working memory and episodic secondary memory. Taking attention for example, patients given placebo showed a significant deterioration from predosing scores at 12 and 20 weeks, whereas patients on rivastigmine performed significantly above their predosing levels. These effects were also large in magnitude, the decline under placebo at week 12 being 19%, while the improvement under rivastigmine was 23%. The clinical relevance of this 23% improvement was that it took the patients 33% towards being normal for their age on this assessment of attention. These benefits to cognitive function were accompanied by a significant improvement of the other primary outcome measure, the Neuropsychiatric Inventory. Three weeks after discontinuation of rivastigmine, most parameters of cognitive performance returned to predrug levels.

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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