Tuesday, 19 August 2003
This presentation is part of : Tuesday Poster Sessions

PB-045 26-Week Clinical Trial of Galantamine in Patients with Alzheimer's Disease: Comparison Between the Patients Previously Exposed to Other Acetylcholinesterase Inhibitors and Those Never Exposed

Myeong-Il Han1, Hyeong-Mo Gu1, Hyoung-Suk Lee1, Ki-Rip Jung1, and Doh Kwan Kim2. (1) Psychiatry, Samsung Medical Center, Seoul, South Korea, (2) Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

Objective: The aim of this study was to compare the therapeutic efficacy of galantamine, in the patients with Alzheimer's disease (AD), between the patients previously exposed to other acetylcholinesterase inhibitors (AChEIs) and those never exposed.

Design: This was a prospective 26-week, single blind comparison study.

Materials and Methods: Twenty patients who met the criteria of probable AD according to NINCDS-ADRDA were recruited in this study. The subjects achieved a score range of 10 to 24 on the Mini-Mental State Examination. Six patients had a previous medication history with other AChEIs, donepezil or rivastigmine, for at least 6 months with no clinical benefits. And 14 patients had no history of drug medication with AChEIs. We measured the functional changes of the patients, administered with galantamine for 26 weeks, by using Alzheimer's Disease Assessment Scale-cognitive section (ADAS-cog), Korean version of Mini Mental State Examination (K-MMSE), Instrumental Activities of Daily Living (IADL), Activities of Daily Living (ADL), Clinical Dementia Rate (CDR) and Neuropsychological Inventory (NPI). Interaction effect of time (pre- and post- trial) and group (AChEI switched and never-exposed group) was analyzed by repeated measure of analysis of variance to examine the difference between the groups in terms of time course.

Results: Baseline demographics (age, sex, education year, duration of illness) were similar between two groups. There was no significant difference in ADAS-cog, K-MMSE, IADL, ADL, NPI and CDR at baseline. At 4-week, 13-week and 26-week after galantamine trial, there were no significant differences between two groups in ADAS-cog, K-MMSE, IADL, ADL, and NPI. The patient group who were never exposed to AChEIs showed a trend of positive change in frontal lobe functioning compared to the switched group.

Conclusion: This study showed galantamine has a similar therapeutic efficacy in demented patients regardless of their medication history of other AChEIs. And even the patients who were not responding to other AChEIs had no significant differences in neuropsychological and behavioral changes compared to those never exposed to AChEIs. Further data will be collected and presented.

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