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Recruiting NCT05826457

North American Prodromal Synucleinopathy Consortium Stage 2

Trial Parameters

Condition REM Sleep Behavior Disorder
Sponsor Washington University School of Medicine
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-08-12
Completion 2025-05-01

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria for RBD Group 1. Polysomnogram-confirmed RBD by ICSD-3 criteria 2. Capable of providing informed consent at time of study enrollment 3. Age \> 18 years Exclusion Criteria for RBD Group 1. Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1. 2. Narcolepsy-associated RBD 3. RBD secondary to any known cause except prodromal synucleinopathy. 4. Participation in a clinical trial, except by specific permission by the Executive Committee 5. 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 1. Ability to provide written consent 2. Age \> 18 years 3. Must meet age, sex, and race matching criteria per the Data Management and Statistical core recommendations for the site 4. Must be willing to undergo all testing procedures, including neuroimaging and lumbar puncture. 5. Normal capacity to perform

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