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Vol. 17, No. 1-2, 2004
Issue release date: December 2003
Section title: Original Research Article
Dement Geriatr Cogn Disord 2004;17:29–34
(DOI:10.1159/000074140)

Management of Patients with Alzheimer’s Disease plus Cerebrovascular Disease: 12-Month Treatment with Galantamine

Bullock R. · Erkinjuntti T. · Lilienfeld S. · GAL-INT-6 Study Group G.
aKingshill Research Centre, Victoria Hospital, Swindon, UK; bHelsinki University Central Hospital, Helsinki, Finland, and cJanssen Pharmaceutica, Titusville, N.J., USA

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Article / Publication Details

First-Page Preview
Abstract of Original Research Article

Received: 6/3/2003
Published online: 12/11/2003

Number of Print Pages: 6
Number of Figures: 1
Number of Tables: 3

ISSN: 1420-8008 (Print)
eISSN: 1421-9824 (Online)

For additional information: http://www.karger.com/DEM

Abstract

We evaluated the long-term cognitive effects and safety of galantamine 24 mg/day in patients with Alzheimer’s disease plus cerebrovascular disease (AD + CVD or mixed dementia). Subgroup analysis was performed of patients with AD + CVD who participated in a 6-month, multicenter, randomized, double-blind, parallel-group study and a 6-month, open-label, active-treatment extension. Method: Two hundred and eighty-five patients with AD + CVD were randomized to receive either placebo (n = 97) or galantamine 24 mg/day (n = 188) for 6 months. Two hundred and thirty-eight (84%) patients continued with the open-label phase of the study (86 from the placebo group, 152 from the galantamine group) and were treated with galantamine 24 mg/day. The primary efficacy measure was cognitive performance as assessed using the eleven-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog/11). Standard safety evaluations and adverse-event monitoring were performed throughout the 12-month study period. Patients with AD + CVD treated with galantamine experienced statistically and clinically significant improvement in cognition at month 6 (mean change in ADAS-cog/11 score –1.1; p ≤ 0.05 vs. baseline) and maintained their cognitive function for the entire 12-month study (mean change in ADAS-cog/11 score +0.1). In contrast, the cognitive function deteriorated among those in the placebo group (mean change in ADAS-cog/11 at month 6 +2.0; p ≤ 0.001 vs. baseline). Patients with AD + CVD who were switched from placebo to galantamine for the open-label phase of the trial did show improvement in cognitive function; however, they never attained the same cognitive level as patients who had been treated with galantamine for the entire 12 months [mean (± SE) ADAS-cog/11 scores in the placebo/galantamine group 25.7 ± 1.32 and 24.2 ± 1.57 at months 6 and 12, respectively, and in the galantamine/galantamine group 21.5 ± 0.87 and 22.2 ± 1.06 at months 6 and 12, respectively]. The results of this subgroup analysis indicate that galantamine is effective for long-term maintenance of the cognitive function in patients with AD + CVD and is safe and well tolerated in this patient population.


  

Author Contacts

Roger Bullock, MD
Kingshill Research Centre, Victoria Hospital
Okus Road
Swindon SN4 9PU (UK)
Tel. +44 1793 437501, Fax +44 1793 437636, E-Mail roger.bullock@kingshill-research.org

  

Article Information

Accepted: May 27, 2003
Published online: October 13, 2003
Number of Print Pages : 6
Number of Figures : 1, Number of Tables : 3, Number of References : 26

  

Publication Details

Dementia and Geriatric Cognitive Disorders

Vol. 17, No. 1-2, Year 2004 (Cover Date: December 2003)

Journal Editor: V. Chan-Palay, New York, N.Y.
ISSN: 1420–8008 (print), 1421–9824 (Online)

For additional information: http://www.karger.com/journals/dem


Article / Publication Details

First-Page Preview
Abstract of Original Research Article

Received: 6/3/2003
Published online: 12/11/2003

Number of Print Pages: 6
Number of Figures: 1
Number of Tables: 3

ISSN: 1420-8008 (Print)
eISSN: 1421-9824 (Online)

For additional information: http://www.karger.com/DEM


Copyright / Drug Dosage

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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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