2017 Volume 33 Issue 4 Pages 566-571
[Objectives]
A randomized single blinded, placebo–controlled study was conducted to evaluate the efficacy of Zonisamide (ZNS) for treating the Behavioral Psychological Symptoms of Dementia (BPSD) in patients with Dementia with Levy bodies (DLB).
[Subjects]
Thirteen patients with probable DLB diagnosed by the criteria of the Consensus Guidelines for the clinical and pathologic diagnosis of DLB revised by the Consortium on DLB International Workshop in 2005 : 6 assigned to the treatment group with ZNS and 7 assigned to the control group.
[Methods]
The subjects in the treatment group were medicated with ZNS 100mg/day. The primary efficacy endpoints were changes from baseline in the Neuropsychiatric Inventory (NPI) scores over the 2–week and 4–week treatment periods. The secondary endpoints were changes in Mini Mental State Examination (MMSE), The NPI– Brief Questionnaire Form (NPI–Q), and the Unified Parkinson's Disease Rating Scale (UPDRS) ; MMSE and NPI–Q were assessed at 2 and 4 weeks after the start of dosing, while UPDRS was assessed once at 4 weeks after the start of dosing.
[Results]
There were no significant differences in the baseline assessment between the two groups. As the clinical trial results, no significant differences were demonstrated in both the primary and secondary endpoints. However, NPI total scores showed the tendency toward improvement in the treatment group, and regarding the adverse events, hallucination and anorexia were reported in one subject.
[Conclusion]
Statistically significant differences were not demonstrated due to the small sample size. It is required to conduct a dose finding study with larger number of subjects.
