Thursday, 21 August 2003
This presentation is part of : Thursday Poster Sessions

PD-022 The Effect of Galantamine on Behavior Changes in Patients with Vascular Dementia and Alzheimer's Disease with Cerebrovascular Disease

Howard Feldman, Division of Neurology, UBC Hospital, Vancouver, BC, Canada, Sean Lilienfeld, Janssen Pharmaceutica, Inc., Titusville, NJ, USA, and Atul R. Mahableshwarkar, Janssen Pharmaceutica Products, L.P., Titusville, NJ, USA.

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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