An Exploratory Open-Label Trial of Ziprasidone for the Treatment of Behavioral and Psychological Symptoms of Dementia

OBJECTIVE: To evaluate the efficacy and tolerability of ziprasidone in behavioral and psychological symptoms of dementia. METHOD: A 7-week open-label trial of ziprasidone. RESULTS: Of the 25 patients who participated, 15 completed the study. The main reason for discontinuation was adverse events. The mean total Neuropsychiatric Inventory (NPI) score fell significantly from 47.1 +/- 17.1 (baseline) to 25.8 +/- 17.9 (day 49) (p < 0.01). The NPI caregiver burden showed a significant improvement from 22.6 +/- 8.3 at baseline to 11.8 +/- 7.3. The most frequent adverse events were somnolence, gastrointestinal symptoms and parkinsonism. CONCLUSIONS: Ziprasidone was able to significantly improve distressing non-cognitive symptoms of dementia although adverse effects occurred. Additional large-scale, double-blind, well-controlled studies are necessary to evaluate the use of ziprasidone in this indication.