Background: Alzheimer’s disease (AD) is characterized by a progressive decline in cognitive and global functions in advanced stages of the disease. Galantamine, a novel AChE-inhibiting drug with a unique feature of nicotinic receptor modulation has shown significant improvements on cognition in large placebo-controlled clinical trials.
Objective: To assess the long-term delay in disease progression with galantamine in AD patients over 4 years based on two controlled clinical trials with open-label extensions and additional safety evaluation.
Design: A long-term follow-up of two international 3-6 month placebo-controlled clinical trials with open-label extension trials was performed to investigate the efficacy of galantamine 24mg/day in Alzheimer’s disease (AD) patients for a total of 48 months.
Materials and Methods: 240 patients with initially mild-to-moderate AD out of the open-label extensions up to 36 months were included in a further 12-month extension trial. Changes were recorded from the initial visit to month 12 (of the current extension trial) and from baseline to month 48 (since the beginning of the double-blind trials that were pooled during open-label extension phases) or until withdrawal. The patients’ cognition was assessed by ADAS-cog/11 and compared to the predicted deterioration in untreated patients (Stern equation) over 48 months. The safety recordings comprised treatment-emergent adverse events.
Results: The decline in ADAS-cog scores in galantamine treated patients was much slower over the course of the follow-up trials with a trend towards increasing difference over time compared to the predictions in untreated patients. After 48 months the patients showed only a mean decline in ADAS-cog scores of 12.6 points, whereas for untreated patients the Stern equation would have predicted a mean deterioration of 28 points over 4 years. Discontinuation rate in the actual follow-up trial was 23% (N=55/240), whereof only 5.4% were related to adverse events. In the 4th year of treatment the incidence of side effects such as nausea and vomiting was 2.9% and 1.3%, respectively.
Conclusion: Galantamine shows sustained efficacy and has a favorable safety profile in long-term treatment over 4 years. The cognitive decline with galantamine treatment is less than half of the predicted decline in untreated patients and shows an increasing difference over time. It may be concluded that AD patients may still benefit from galantamine treatment even after 4 years. Continuous long-term treatment with galantamine may offer significant benefits for patients and caregivers and may avoid early institutionalization.
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