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Table of Contents
Vol. 20, No. 2-3, 2005
Issue release date: August 2005
Section title: Original Research Article
Dement Geriatr Cogn Disord 2005;20:120–132
(DOI:10.1159/000086613)

Galantamine Prolonged-Release Formulation in the Treatment of Mild to Moderate Alzheimer’s Disease

Brodaty H.a · Corey-Bloom J.b · Potocnik F.C.V.c · Truyen L.d · Gold M.d · Damaraju C.R.V.d
aUniversity of New South Wales, Sydney, Australia; bUniversity of California, San Diego, Calif., USA; cStikland Hospital, Bellville, South Africa; dJohnson & Johnson Pharmaceutical Research and Development, Titusville, N.J., USA

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Article / Publication Details

First-Page Preview
Abstract of Original Research Article

Received: February 23, 2005
Published online: August 19, 2005
Issue release date: August 2005

Number of Print Pages: 13
Number of Figures: 4
Number of Tables: 4

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

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

Abstract

The primary objective of this study was to evaluate the efficacy and tolerability of a flexible dosing regimen (16 or 24 mg/day) of galantamine prolonged-release capsule (PRC) compared with placebo in subjects with mild to moderate Alzheimer’s disease (AD). This phase III, double-blind, placebo- and active-controlled, parallel-group trial randomized 971 patients to treatment for 6 months. Efficacy endpoints included change in the 11-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog/11), Clinician’s Interview-Based Impression of Change plus caregiver input (CIBIC-plus), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), and Neuropsychiatric Inventory (NPI) scores. Galantamine was associated with significant improvements in the ADAS-cog/11 score but not in the CIBIC-plus or NPI scores. Galantamine PRC was associated with significant improvement in ADCS-ADL scores. Galantamine PRC had similar tolerability and safety profiles compared with twice-daily galantamine, and when administered as a once-daily flexible dosing regimen of 16 or 24 mg/day, was demonstrated to be as safe and effective for the treatment of mild to moderate AD.

© 2005 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Original Research Article

Received: February 23, 2005
Published online: August 19, 2005
Issue release date: August 2005

Number of Print Pages: 13
Number of Figures: 4
Number of Tables: 4

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

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


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