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临床试验/NCT03623672
NCT03623672Enrolling By Invitation不适用

North American Prodromal Synucleinopathy Consortium

Washington University School of Medicine10 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2018年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
500
试验地点
10
主要终点
Prodromal Synucleinopathy Rating Scale

研究概览

简要总结

This study will enroll participants with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD), for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.

详细描述

REM sleep behavior disorder (RBD) is a rare disorder where people act out their dreams. People with RBD often, but not always, develop Parkinson's Disease, dementia with Lewy bodies, multiple system atrophy, or other neurodegenerative diseases of the synucleinopathy type. The North American Prodromal Synucleinopathy (NAPS) Consortium was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective treatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and other data in order to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants. Participants procedures will include a ~2-hour clinical assessment (medical history and physical exam), questionnaires, blood draw, and (at select sites) optional lumbar puncture.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic REM sleep behavior disorder

排除标准

  • REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia, Parkinson's Disease, etc)
  • Other neurological disorder

结局指标

主要结局

Prodromal Synucleinopathy Rating Scale

时间窗: 2 years

Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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