Objective: To evaluate the behavioral benefits of galantamine in patients with vascular dementia (VaD) or Alzheimer's disease with cerebrovascular disease (AD + CVD).
Design: This was a randomized, double-blind, parallel-group, placebo-controlled, 6-month trial undertaken in Canada, Denmark, Finland, France, Germany, Israel, Poland, The Netherlands, and the United Kingdom. Following a 6-week dose-escalation phase, patients were randomized to receive placebo or galantamine 24 mg/day for 6 months. Galantamine and placebo were administered as identical single tablets taken orally twice daily.
Materials and methods: Behavioral changes were assessed using the total Neuropsychiatric Inventory (NPI) scores. Unadjusted mean changes from baseline were assessed for 10 NPI individual items (aberrant motor behavior, agitation/aggression, anxiety, apathy/indifference, delusions, depression/dysphoria, disinhibition, elation/euphoria, hallucinations, irritability/lability). Patients were monitored for adverse events.
Results: At 6 months, the galantamine group had a significantly better outcome on total NPI than the placebo group (–1.2 vs 1.0 points, p = 0.011). Treatment with galantamine 24 mg/day was superior to placebo on all items except 2 (agitation/aggression and depression/dysphoria), with statistical significant differences (p < 0.05) for anxiety, apathy/indifference, and delusions. In the VaD and AD + CVD subgroups, galantamine was superior to placebo for all but 3 items (depression/dysphoria, hallucinations, irritability/lability) and 4 (agitation/aggression, depression/dysphoria, disinhibition, elation/euphoria) items, respectively. Galantamine was well tolerated. Most adverse events related to galantamine were gastrointestinal in nature, of mild-to-moderate severity, and mainly confined to the dose-escalation period.
Conclusions: Galantamine improves behavioral symptoms in patients with VaD or AD + CVD. Improving behavioral symptoms may enhance quality of life, ease caregiver burden, and postpone placing the patient in a long-term care facility.
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