Galantamine improves behavioural disturbances in outpatients with mild to moderate Alzheimer's disease

Background: Data on cholinesterase inhibitor therapy of patients with mild to moderate Alzheimer's disease (AD) that are suffering from behavioural disturbances are limited. The REMINDER non-interventional study (GAL-ALZ-4014) included the assessment of the effectiveness of galantamine and nootropics on behavioural disturbances and cognition in a set of outpatients with mild to moderate AD under everyday practice conditions.

Methods: During this 12-month, open-label, non-interventional, German, multicenter study patients (>50 years;) were treated either with galantamine or with nootropics, such as piracetame or ginkgo biloba. Treatment decision was made before start of documentation by the treating physician. Effectiveness variables included dementia associated symptoms (behavioural disturbances) and Mini-Mental State Examination (MMSE).

Results: 987 patients were enrolled (ITT population; age 74.9 y, 61% females), 779 receiving galantamine (38% mild, 62% moderate AD) and 208 receiving nootropics (64% mild, 36% moderate AD). Mean MMSE-score improved from baseline to study end by 0.1±4.09 points in the galantamine group and worsened by 1.1±3.16 points in the nootropic group (p<0.001). Changes from baseline of all dementia associated symptoms (risk to self and others, daytime tiredness, aggressiveness, agitation, apathy/social retreat, delusions, hallucinations, night-time awakening, night-time shouting/screaming, night-time perambulation, unsteadiness when walking, vertigo) as assessed by a 7-point-Likert-Scale indicated significant improvements for the galantamine group compared to the nootropics group (p=0.010; Chi² test). Adverse events with a causal relation to galantamine occurred in 6.0% of the patients. Gastrointestinal disorders were most prominent (2.2%), followed by nervous system disorders (1.7%) and vertigo (0.8%). One serious adverse event (circulatory collapse) has been rated as possibly associated with galantamine. In patients receiving nootropics 1.8% adverse events with a causal relationship to the treatment, all being gastrointestinal disorders, have been reported. No serious adverse events have been classified as being associated with nootropics.

Conclusions: In patients with mild to moderate AD effects of galantamine on behavioural disturbances and cognition revealed superiority to nootropics under everyday clinical conditions, as assessed in a pragmatic non-interventional study over 12 months.