Background: Disturbing behavioral and psychological symptoms in Alzheimer’s disease (AD) do not only impair the patient’s quality of life but are also distressing for caregivers and often contribute to the patient’s institutionalization. Galantamine, a novel AD drug with unique nicotinic receptors modulating features, has shown in its large controlled trial program to reduce pre-existing and to delay the onset of newly emerging behavioral symptoms in AD.
Objective: To assess the efficacy of galantamine in behavioral symptoms and behavior-related caregiver burden in a natural setting.
Design: A 3-month, Swiss multicenter trial was performed in patients with mild-to-moderate AD, receiving galantamine at doses escalating from 8mg/day to 24mg/day.
Materials and Methods: All patients completing the 3-month treatment (observed cases, OC) were assessed with the Neuropsychiatric Inventory (NPI) for frequency and severity of behavioral symptoms and related caregiver burden. With the Nurses Observation Scale for Geriatric patients (NOSGER) activities of daily living (ADL) were addressed and responders with stabilized or improved symptoms such as changes in subscales were evaluated. The physicians’ overall impression on galantamine treatment effects was rated with the Clinical Global Impression (CGI) of changes. The intention-to-treat (ITT) safety analysis included all patients receiving at least one dose of galantamine.
Results: From 124 patients enrolled in the study, N=91 (56% female, mean 75 years, 54% moderate AD at baseline and mean 93 weeks since AD diagnose) completed according to protocol (OC sample), N=13 discontinued and N=20 were not included into the final analysis due to protocol violations. Almost each fourth patient had been pre-treated with common cholinesterase inhibitors. After 3 months of galantamine treatment the NPI total score had significantly improved versus baseline (mean 11.3 ± 1.2 versus 14.9 ± 1.2, p<0.005). The most obvious improvements (i.e. reduction in scores) were seen for anxiety, aberrant motor behavior, delusion, euphoria and night-time-behavior (-38% to –31%). The symptoms with highest baseline scores (irritability, depression, apathy and agitation) were improved by –27% to –19%. These pronounced reductions in behavioral symptoms by galantamine treatment led to a significant reduction in mean NPI caregiver burden (p<0.001); 9.4% of all distressed caregivers rated their burden “extremely improved” versus baseline. According to NOSGER 65% of all patients were stabilized or improved (p<0.01); the biggest improvement was seen for "disturbing behavior". The physicians rated the majority of all patients slightly improved, 20% moderately and 2% markedly improved at month 3. Galantamine was well tolerated and few adverse events were seen in >5% of the whole sample.
Conclusion: This open trial has confirmed earlier results from controlled clinical trials in AD patients and provided first evidence that galantamine may significantly improve behavioral symptoms over baseline after 3 months. The treatment success corresponded to a significant reduction in related caregiver distress and a pronounced improvement in the physicians’ global evaluation.
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