Phase II pilot randomized trial of zonisamide for disease modification in prodromal Lewy body disease.

ABSTRACT: Zonisamide exhibits potential neuroprotective properties, but its efficacy during the prodromal stage of Lewy body disease (LBD) remains unclear. In this phase II randomized, double-blind pilot trial, 29 high-risk individuals aged 50-80 years with ≥2 prodromal symptoms and abnormal DaT-SPECT and/or cardiac MIBG were randomized to zonisamide (50-100 mg/day, n = 14) or placebo (n = 15) and treated for 96 weeks. Participants with Parkinson's disease or dementia with Lewy bodies were excluded. No significant between-group difference was observed in the primary outcome, change in DaT-SPECT specific binding ratio from baseline to week 96 (0.072; 95% CI -0.565 to 0.709; p = 0.817), or in secondary outcomes including MIBG parameters and motor and cognitive functions. Non-motor symptoms worsened wi

SUBMITTER: Hiraga K 

PROVIDER: S-EPMC12669779 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature