Objective: To assess the effect of galantamine on behavioral disturbances and associated caregiver burden in community-dwelling patients with AD.
Background: Behavioral and psychotic disturbances occur in up to 90% of patients with Alzheimer's disease (AD), have a substantial impact on both patients and caregivers, and are often associated with the decision to institutionalize patients. Galantamine is a dual-action cholinergic AD treatment (inhibition of acetylcholinesterase and allosteric modulation of nicotinic receptors) that delays the onset of behavioral symptoms, and may decrease behavior-associated caregiver distress.
Design/Methods: In a 3-month, open-label, phase IV, multicenter study conducted in Switzerland, patients with mild-to-moderate AD received galantamine treatment (escalated from 8 mg/day to 24 mg/day over 8 weeks). Efficacy was assessed, based on patients completing 3 months of treatment (observed case [OC] analysis), using the Neuropsychiatric Inventory (NPI) (primary outcome) and the Clinical Global Impression (CGI) (secondary outcome). Safety and tolerability were monitored.
Results: 124 patients (mean age 75.2 years; 55.6% women) received galantamine and were included in the intent-to-treat safety analysis. Significant improvements from baseline in NPI scores (p = 0.004) were seen in the OC efficacy analysis (n = 91); mean ± SE total NPI scores were 14.93 ± 1.17 at baseline and 11.25 ± 1.16 at Month 3. Eleven of 12 NPI domains showed improvement with galantamine. The greatest improvements (30%–38%) were for anxiety, aberrant motor behavior, delusions, euphoria, and nighttime behavior. Significant overall reductions in NPI caregiver burden scores were observed at Month 3 (p = 0.004). Eighty-eight percent of patients showed either improvement or no change in CGI ratings. Adverse events were mostly gastrointestinal in nature.
Conclusion: Galantamine was well tolerated and significantly reduced behavioral disturbances in this general clinical population, an effect that positively impacted on behavior-related caregiver burden.
Back to PD Thursday Poster Sessions
Back to The Eleventh International Congress