Galantamine improves non-cognitive symptoms as compared to nootropics in outpatients with mild to moderate Alzheimer's disease

Aims: In the present non-interventional study (NIS) the effectiveness of galantamine (GAL) and nootropics on non-cognitive symptoms (NCS) in outpatients with Alzheimer's disease (AD) has been investigated under every day routine conditions. Methods: Open-label, multicenter NIS. Patients (61% female) were treated for 12 months either with GAL or nootropics. Primay outcomes were dementia-associated NCS (risk to self and others, daytime tiredness, aggressiveness, agitation, apathy, delusions, hallucinations, night-time awakening, -screaming, -perambulation, unsteadiness when walking, vertigo) as assessed by use of a 7-point Likert scale. Results: 987 patients were enrolled (74.9 y), GAL N=779 (38% mild, 62% moderate AD), nootropics N=208 (64% mild, 36% mod. AD). Changes from baseline of all dementia associated NCS showed improvements for GAL vs. nootropics (p=0.01). Treatment emergent adverse events (TEAE) occurred in 6.0% for GAL group. Gastrointestinal disorders (GID) (2.2%), CNS disorders (1.7%) and vertigo (0.8%) were most prevalent. In patients receiving nootropics 1.8% TEAE were reported, all being GID. One serious TEAE (circulatory collapse) occurred in the GAL group. Conclusions: In patients with mild to moderate AD galantamine showed superior long-term therapeutic effects on dementia-associated non-cognitive symptoms as compared to nootropics. These results from everyday routine conditions complete positive data on NCS from randomized controlled studies.