A Cochrane review [Abstract] 1 included 2 RCTs with a total of 1378 subjects. Both trials were of 6 months duration and were testing a galantamine dose of 16-24 mg/day vs. placebo.
The GAL-INT-6 trial included 592 patients with vascular dementia diagnosed according to recognised criteria and patients with Alzheimer's disease and coincidental radiographic findings of cerebrovascular disease. In the whole trial population significant treatment effects in favour of galantamine were noted in cognition (ADAS-cog, MD -2.29, 95% CI -3.46 to -1.12), activities of daily living (DAD, MD 4.10, 95% CI 1.25 to 6.95) and behaviour (NPI, MD -2.06, 95% CI -4.09 to -0.03). Significantly higher numbers of patients dropped out (102/396 galantamine, 33/196 placebo; OR 1.71, 95% CL 1.11 to 2.65) and withdrew due to an adverse event (79/396 galantamine, 16/196 placebo, OR 2.80, 95% CI 1.59 to 4.95), especially gastrointestinal, from the group treated with galantamine.
A second trial (GAL-INT-26) involved 788 patients with vascular dementia, which was diagnosed using standard criteria. Statistically significant benefits favouring galantamine in assessments of cognition (ADAS-cog, MD -1.50, 95% CI -2.39 to -0.61), and favouring placebo for behaviour (NPI, MD 1.80, 95% CI 0.29 to 3.31) were recorded. Significantly higher numbers of patients dropped out from the galantamine group vs. placebo (50/396 galantamine, 25/390 placebo OR 2.11, 95% CL 1.28 to 3.49).
Comment: The quality of evidence is downgraded by imprecise results (limited study size for each comparison) and by indirectness (differences in studied patients; GAL-INT-6 recruited also patient with Alzheimer's disease).
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