Studies people with REM sleep behavior disorder to prepare future brain-protection trials
Enrolls people with REM sleep behavior disorder and healthy volunteers, to prepare future trials.
Plain-language title generated from the registry record
Registry title: North American Prodromal Synucleinopathy Consortium Stage 2
Key facts
- Where
- Montreal, CanadaSee the site
Where in Canada
- McGill University Health Centre Research InstituteMontreal, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Washington University School of Medicine
- Trial code
- NCT05826457
- Record updated
- 13 May 2026
- Original description
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.Read full original descriptionShow less
North American Prodromal Synucleinopathy Consortium Stage 2
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.
Inclusion: 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: Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1; 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; In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol; 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; Contraindications to complete MRI; Contraindications to lumbar puncture; Participation in a clinical trial, except by specific permission by the Executive Committee.