The purpose of this study was to explore factors that influence the clinical safety and tolerability
associated with galantamine administration in Thai Alzheimer’s disease patients with or without cerebrovascular
disease and vascular dementia. This was an analysis of previous study. Tolerability and safety profile
were analyzed according to sex, age, body weight, Thai mental state examination (TMSE) score, Alzheimer’s
disease assessment scale-cognitive subscale (ADAS-cog) score, and Alzheimer’s disease cooperative study/
activities of daily living (ADCS/ADL) score.

The most common adverse events were nausea, dizziness, and weight loss which more often occurred
during the dose-escalation phase. Mean body weight lost at week 24 was 0.9 kg. Sex, age, body weight, and
ADAS-cog score did not influence the incidence of any adverse events. Dizziness was more likely to occur in
patients with low TMSE and high ADCS/ADL score (p = 0.02 and p = 0.050, respectively). Patients with TMSE
score equal or higher than 23 more often experienced muscle cramps and fatigue than who had TMSE lower
23 (p < 0.05). However, flexible dose escalation of galantamine with a 4-week schedule was safe and well
tolerated in Thai AD patients.

Keywords: Alzheimer disease, Dementia, Vascular, Drug tolerance, Galantamine, Safety