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.


CONCLUSIONS
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.
Monsch
Andreas U
AU
Memory Clinic, Geriatric University Hospital, Basel, Switzerland. andreas.monsch@unibas.ch
Giannakopoulos
Panteleimon
P
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000451:nursing / Q000523:psychology*; D017028:Caregivers / Q000523:psychology*; D005260:Female; D005702:Galantamine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy*; D008875:Middle Aged; D018697:Nootropic Agents / Q000627:therapeutic use*; D013557:Switzerland
D018697:Nootropic Agents; D005702:Galantamine