Background: Based on the emergence of effective new drugs for Alzheimer’s disease (AD) there is increasing demand not only to slow down the disease progression but also to maintain or even improve the patients’ performance for an extended period of time. Galantamine, unlike standard acetylcholinesterase inhibitors, has an additional unique modulating effect on the nicotinic receptors, thus stimulating the cerebral neurotransmission and increasing the effects on cognition and other affected domains. Galantamine has consistently shown significant short-term and long-term benefits on cognition, activities of daily living and global functions such as on behavioral symptoms in patients with AD and mixed dementia with cerebrovascular components and vascular dementia. The long-term benefits of galantamine treatment have furthermore shown to substantially improve the care giving domain.
Objective: To assess the short-term and long-term efficacy of galantamine 16mg and 24mg in patients with predominantly mild AD.
Design: A 6-month, German multicenter clinical trial including 245 patients with mild AD was followed by an open extension phase for up to one year. Actually, 60 patients are eligible for 12-month results from this ongoing trial.
Materials and Methods: The primary efficacy was assessed by ADAS-cog/11 at month 3, 6, 9, and 12 and confirmed by the Clinical Global Impression (CGI) of changes. Short-term improvements were furthermore rated by quartile analyses for ADAS-cog changes and special attention was drawn to long-term improvements in orientation, language and memory.
Results: 149 out of 245 patients with a mean baseline ADAS-cog score of 24 and a mean age of 72 years responded with significant cognitive improvements after 6 months versus baseline (mean changes in ADAS-cog/11 –1.9 points, p<0.001). Almost ¼ of all patients improved their ADAS-cog score by more than 10 points. In the first 60 patients included in this interim long-term analysis, the mean cognition score remained above baseline throughout the whole observation period over 12 months and the language performance was significantly better compared to baseline in the long-term assessment. The CGI rating was improved in the majority of all patients and rated “excellent” or ”good” in one out of four patients after 12 months. 95% of all galantamine treated patients did not experience adverse events at the CGI rating after 12 months.
Conclusion: Galantamine shows significant improvements in cognition even in mild AD patients and provides distinct long-term improvements over baseline in cognitive and global performance. The favorable safety and tolerability profile supports a long-term treatment with galantamine over the course of the disease.
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