Galantamine Prolonged-Release Formulation in the Treatment of Mild to Moderate Alzheimer’s DiseaseBrodaty H. · Corey-Bloom J. · Potocnik F.C.V. · Truyen L. · Gold M. · Damaraju C.R.V.
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
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.
Henry Brodaty, MD, FRACP, FRANZCP
Aged Care Psychiatry
Prince of Wales Hospital, Avoca Street
Randwick, New South Wales, 2031 (Australia)
Tel. +61 2 9382 3759, Fax +61 2 9382 3762, E-Mail firstname.lastname@example.org
Dr. Brodaty has received consultancy fees and a grant from Janssen and has been a sponsored speaker.
Accepted: February 23, 2005
Published online: June 30, 2005
Number of Print Pages : 13
Number of Figures : 4, Number of Tables : 4, Number of References : 29
Dementia and Geriatric Cognitive Disorders
Vol. 20, No. 2-3, Year 2005 (Cover Date: Released August 2005)
Journal Editor: Chan-Palay, V. (New York, N.Y.)
ISSN: 1420–8008 (print), 1421–9824 (Online)
For additional information: http://www.karger.com/dem