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<p>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; <i>p</i> = 0.817), or in secondary outcomes including MIBG parameters and motor and cognitive functions. Non-motor symptoms worsened with zonisamide, whereas two placebo recipients developed Parkinson’s disease. Somnolence, fatigue, decreased appetite, and constipation were frequent adverse events. Although findings are inconclusive due to limited power, this study provides valuable methodological insights for preventive LBD trials.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月1日

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  • Keita Hiraga,
  • Makoto Hattori,
  • Daigo Tamakoshi,
  • Yuki Satake,
  • Taiki Fukushima,
  • Yuki Saito,
  • Takashi Uematsu,
  • Takashi Tsuboi,
  • Maki Sato,
  • Katsunori Yokoi,
  • Keisuke Suzuki,
  • Yutaka Arahata,
  • Yoshino Ueki,
  • Fumie Kinoshita,
  • Hiroshi Matsuda,
  • Akihiro Murata,
  • Masayuki Yamamoto,
  • Masakazu Wakai,
  • Noriyuki Matsukawa,
  • Yukihiko Washimi,
  • Masahisa Katsuno

摘要

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 with zonisamide, whereas two placebo recipients developed Parkinson’s disease. Somnolence, fatigue, decreased appetite, and constipation were frequent adverse events. Although findings are inconclusive due to limited power, this study provides valuable methodological insights for preventive LBD trials.