NCT05611372撤回2 期
Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 732 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 732
- 主要终点
- Disease-free survival time
研究概览
简要总结
To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PSG confirmed RBD with subtle motor symptoms (4≤MDS-UPDRS-III≤10 at baseline)
- •no clinical diagnosis of Parkinson's disease or dementia at baseline
- •age 30-75
- •no concomitant or previous use of any other anti-parkinson medications
- •provide written informed consent
排除标准
- •diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic)
- •secondary RBD (eg., drug-induced, immune-mediated)
- •nervous system comorbidities (eg., stroke, epilepsy, encephalitis)
- •severe psychiatric comorbidities
- •allergic to rasagiline
- •severe systemic diseases (eg., end-stage kidney disease, liver failure)
研究组 & 干预措施
Early Intervention
Experimental
0-52 week: rasagiline 1 mg/day
干预措施: Rasagiline (Drug)
Delayed Intervention
Active Comparator
0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day
干预措施: Rasagiline (Drug)
结局指标
主要结局
Disease-free survival time
时间窗: 3 years after starting rasagiline treatment
Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy)
次要结局
- MoCA(0-3 years after starting rasagiline treatment)
- MMSE(0-3 years after starting rasagiline treatment)
- Striatal dopaminergic innervation(0-3 years after starting rasagiline treatment)
- HAMA(0-3 years after starting rasagiline treatment)
- HAMD(0-3 years after starting rasagiline treatment)
- PSQI(0-3 years after starting rasagiline treatment)
- MDS-UPDRS-III(0-3 years after starting rasagiline treatment)
- RBDQ-HK(0-3 years after starting rasagiline treatment)
- PDQ39(0-3 years after starting rasagiline treatment)
- SCOPA-AUT(0-3 years after starting rasagiline treatment)
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