North American Prodromal Synucleinopathy Consortium Stage 2
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 18
- 主要终点
- Prodromal Synucleinopathy Rating Scale
研究概览
简要总结
This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls 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 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 Consortium Stage 2 (NAPS2) was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective trreatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and neuroimaging data. The RBD group will also undergo two overnight sleep studies. Some of this data will be used to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants.
RBD group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI and DaTscan), polysomnogram (sleep study), and optional lumbar puncture.
Control group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI), and lumbar puncture.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •for RBD Group
- •Polysomnogram-confirmed RBD by ICSD-3 criteria
- •Capable of providing informed consent at time of study enrollment
- •Age > 18 years
排除标准
- •for RBD Group
- •Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS
- •Narcolepsy-associated RBD
- •RBD secondary to any known cause except prodromal synucleinopathy.
- •Participation in a clinical trial, except by specific permission by the Executive Committee
- •In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
- •Inclusion Criteria for Control Group
- •Ability to provide written consent
- •Age > 18 years
- •Must meet age, sex, and race matching criteria per the Data Management and Statistical core recommendations for the site
- •Must be willing to undergo all testing procedures, including neuroimaging and lumbar puncture.
- •Normal capacity to perform complex activities of daily living independently based on informant or physician report
- •Exclusion Criteria for Control Group
- •History of dream enactment behavior to suggest RBD
- •Parkinsonism, MSA, dementia, or mild cognitive impairment
- •Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning.
- •Contraindications to complete MRI.
- •Contraindications to lumbar puncture.
- •Participation in a clinical trial, except by specific permission by the Executive Committee
- •In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
结局指标
主要结局
Prodromal Synucleinopathy Rating Scale
时间窗: up to 5 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