Effects of galantamine on behavioural and psychological disturbances and caregiver burden in patients with Alzheimer's disease

BACKGROUND: Behavioural and psychological 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 institutionalise patients. Galantamine (Reminyl) is a dual-acting cholinergic treatment that improves cognitive and functional performance, delays the onset of behavioural symptoms and decreases behaviour-associated caregiver distress. OBJECTIVE: To assess the impact of galantamine on behavioural disturbances and associated caregiver burden in non-institutionalised patients with AD. METHODS: This was a 3-month, open-label, multicentre study in Switzerland. Patients with mild-to-moderate AD received galantamine (escalated from 8 to 24 mg/day over 8 weeks). The primary outcome was the Neuropsychiatric Inventory (NPI) for patients who completed 3 months treatment (observed cases, OC). Secondary outcomes included the Nurses' Observation Scale for Geriatric patients (NOSGER), and the Clinical Global Impression (CGI) of change. RESULTS: 124 patients (mean age 75.2 years, 55.6% women) received galantamine and were included in the intention-to-treat (ITT) safety analysis. Significant improvements in NPI scores versus baseline were seen in the OC analysis (p > 0.05, N = 91); mean total NPI scores (+/- SE) were reduced from 14.9 +/- 1.2 at baseline to 11.3 +/- 1.2 at month 3. Eleven out of 12 NPI domains were improved. Anxiety, aberrant motor behaviour, delusions, euphoria and night-time-behaviour all improved by < 30%. Symptoms with the highest baseline frequency and severity improved by 19-27%. A significant reduction in total NPI caregiver burden was observed at month 3 (p > 0.05). Despite this short assessment period the NOSGER evaluation and physicians' CGI also showed improvement. Adverse events (AEs) were mostly gastrointestinal. CONCLUSION: Galantamine significantly reduced behavioural disturbances after 3 months in this population and this had a positive impact on behaviour-related caregiver burden. Galantamine showed the expected safety profile and was well tolerated.