Objective: To investigate the long-term safety and efficacy of galantamine in patients diagnosed with probable vascular dementia (VaD).
Background: Dementia is common among the growing elderly population. The most prevalent forms of dementia worldwide are Alzheimer s disease (AD) and VaD. Therapeutic options such as the acetylcholinesterase inhibitors have been available for the treatment of AD for many years; however, limited treatment options exist for patients diagnosed with VaD. Evidence of important cholinergic deficits in patients with VaD suggests that treatment with cholinergic agents may be beneficial. Galantamine is a novel cholinergic drug with a dual mode of action (inhibition of acetylcholinesterase and allosteric nicotinic receptor modulation) currently approved for treatment of mild-to-moderate AD.
Design and Methods: Patients with probable VaD or AD with cerebrovascular disease (AD + CVD) who completed a 6-month, double-blind, placebo-controlled study and a 6-month, open-label extension phase (N = 374) were eligible to enter a further open-label extension study. This study was a multicenter, 2-year, open-label extension trial with fixed daily dose of galantamine 24 mg/day in patients diagnosed with probable VaD or AD + CVD (n = 326). Safety and tolerability were evaluated. Changes in cognitive function were assessed by the Alzheimer s Disease Assessment Scale cognitive subscale (ADAS-cog/11). This analysis was performed in VaD patients at month 12 of the 2-year extension study (total treatment duration: 24 months).
Results: 135 of 326 patients who entered the 2-year, open-label extension had a diagnosis of VaD. Of these, 87 patients had received galantamine continually for 24 months. Continuous galantamine treatment maintained cognitive levels close to baseline levels for 24 months as measured by the ADAS-cog/11 (change from baseline: 0.8 1.00), which was not significantly different statistically from baseline. Adverse events were not increased in this patient population on long-term therapy. The most frequently occurring adverse events in the first year of this 2-year extension study were characteristic of those expected for an elderly population with dementia and included depression, agitation, and insomnia. The incidence of gastrointestinal symptoms decreased as therapy lengthened.
Conclusions: Long-term therapy with galantamine in patients diagnosed with probable VaD is safe and effective in preventing cognitive decline for 24 months. Galantamine treatment has provided a viable option in this group of patients, for whom limited therapeutic interventions are available.
Back to S030 New Findings in the Pharmacology of Dementia
Back to The Eleventh International Congress