Abstract Details

Title Long-Term Efficacy for Parkinsonism and Safety of Zonisamide in Patients with Dementia with Lewy Bodies: A Phase III Trial

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-011

Objective To evaluate the long-term efficacy for parkinsonism and tolerability of zonisamide in patients with dementia with Lewy bodies (DLB)

Background Not applicable

Design/Methods Outpatients diagnosed with probable DLB were randomized into 3 groups (placebo, zonisamide 25 and 50 mg/day) and then treated with fixed dose of test drugs for 12 weeks in a double-blind (DB) manner. Subsequently, all patients received 25-mg/day zonisamide over 2 weeks and then the flexible dose (25 or 50 mg/day) was allowed according to patients’ conditions in a 40-week, open-label (OL) extension phase. The efficacy (UPDRS part 3, MMSE and NPI-10) and safety were evaluated.

Results After randomization, 346 patients who took zonisamide at least once after the DB phase were included in the analyses (At baseline; mean age, 77.2 years; mean durations of dementia and movement dysfunction, 3.6 and 2.7 years; mean levodopa dose, 251 mg/day). Approximately 60% of patients took zonisamide 50 mg more frequently than 25 mg in the final 4-week period. The score reduction in UPDRS part 3 continued until 24-28 weeks around, and then the score maintained until the final evaluation time point (31.9 to 25.6 in the 25-mg/day group; 31.2 to 25.1 in the 50-mg/day group). No remarkable score change in MMSE or NPI-10 showed throughout the trial. Adverse events newly developed in the OL phase or largely increased compared with those developed in the DB phase were not found.

Conclusions Zonisamide shows the long-term efficacy for DLB parkinsonism without deterioration of cognitive function, BPSD and safety in DLB patients.

Authors/Disclosures
Shunji Toya PRESENTER	Shunji Toya has received personal compensation for serving as an employee of Sumitomo Dainippon Pharma Co., Ltd..
	No disclosure on file
	No disclosure on file
Kazuko Hasegawa, MD (Dept Neurology, Sagamihara Natl Hospital)	Dr. Hasegawa has nothing to disclose.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

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