RecruitingNCT05826457

North American Prodromal Synucleinopathy Consortium Stage 2

Sponsor

Washington University School of Medicine

Enrollment

500 participants

Start Date

Aug 12, 2022

Study Type

OBSERVATIONAL

Conditions

Multiple System Atrophy Parkinson Disease Dementia With Lewy Bodies Lewy Body Dementia REM Sleep Behavior Disorder REM Sleep Parasomnias

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

Min Age: 18 Years

Inclusion Criteria8

Polysomnogram-confirmed RBD by ICSD-3 criteria
Capable of providing informed consent at time of study enrollment
Age \> 18 years
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 Criteria12

Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
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
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