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.