JPRN-jRCTs041180125已完成3 期
The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies - The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies
Washimi Yukihiko0 个研究点目标入组 25 人开始时间: 2019年3月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
The results of the present study showed no trend for improvement in the BPSD of DLB with zonisamide, which was seen in our exploratory study, based on the amount of change in NPI after 2 and 4 weeks, and zonisamide was not shown to be effective against the BPSD of DLB.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 55age old 至 <= 84age old（—）
- 性别
- All
入选标准
- •1 Probable DLB with the criteria of DLB workshop 2005
- •2 BPSD is present on NPI
- •3 MMSE score 10 26
- •4 WBC platelet Serum AST ALT ALP GTP level should be in normal range
- •5 Have a study partner able to provide an independent evaluation of functioning
- •6 Agreement to sign an informed consent
排除标准
- •1 Patient with non DLB.
- •2 No focal lesion exists in brain MRI.
- •3 Has current serious illness, psychiatric problem or drug abuse.
- •4 Those who have used Zonisamide over before.
- •5 Those who have joined any clinical trial within 3 month.
- •6 Those who have received medications that affected the central nervous system within 4 weeks.
- •7 Dose of chronic medications that affect CNS should be stable for at least 4 weeks before Visit0.
- •8 Those who are judged inadequate by their doctor.
研究者
相似试验
已完成
2 期
The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies. A randomized, single-blind, placebo-control trial.Dementia with Lewy bodiesJPRN-UMIN000010631ational Center for Geriatrics and Gerontology24
尚未招募
3 期
The efficacy of Zonisamide for BPSD in Dementia with Lewy bodiesDementia with Lewy bodiesJPRN-UMIN000027312ational Center for Geriatrics and Gerontology90
尚未招募
1 期
Zonisamide a new drug drug for parkinson disease as additional drug to ongoing treatment for Parkinson: a randomized double blind placebo control studyCTRI/2019/11/022095Atul Goel
已完成
不适用
on-inferiority study of zonisamide versus levodopa preparations in DLB parkinsonismParkinsonism with Dementia with Lewy bodiesJPRN-jRCTs051200054Ikeda Manabu130
已完成
4 期
The pharmacoepidemiological study of Zonisamide for Parkinson's diseaseParkinson's DiseaseJPRN-UMIN000026890Ehime University Graduate School of Medicine9,157