Effects of washout and dose-escalation periods on the efficacy, safety, and tolerability of galantamine in patients previously treated with donepezil: ongoing clinical trials.

Rasmusen L, Yan B, Robillard A, Dunbar F

Inova Health Research, Inc,
Kelowna, British Columbia, Canada.

ABSTRACT

With the increasing number of acetylcholinesterase inhibitors (AChEIs) being marketed for the treatment of Alzheimer’s disease (AD), physicians will need protocols for discontinuing one AChEI and initiating another (“switching”). Three clinical trials have been designed to provide data that will assist in the determination of the optimal conditions for switching patients from donepezil (the most widely prescribed AChEI) to galantamine (the most recently approved AChEI). The main objective of these studies is to investigate the effects of different washout periods (0 to 7 days) and dose-escalation schedules (fixed, fast vs slow) on the efficacy, safety, and tolerability of galantamine in patients with AD who were previously taking donepezil. The duration of the trials ranges from 12 to 52 weeks, and the last trial is expected to end in May 2002. No conclusions can yet be drawn from these ongoing trials, but the results should be helpful in establishing guidelines for physicians to use when switching patients with AD from donepezil to galantamine.