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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with REM sleep behavior disorder (RBD) confirmed by a sleep study, and healthy adults as a control group.
- Age
- Adults over 18 years.
- Sex
- All sexes can join.
- Disease stage
- RBD group: REM sleep behavior disorder confirmed by an overnight sleep study (polysomnogram). Control group: no sign of RBD.
Main reasons for not taking part
- RBD group: Parkinson's disease, any dementia, or multiple system atrophy (MSA), unless the person took part in NAPS1
- RBD group: narcolepsy-related RBD, or RBD with a known cause other than an early synucleinopathy
- Control group: history of acting out dreams, parkinsonism, MSA, dementia or mild cognitive impairment
- Control group: cannot have a full MRI or a lumbar puncture
- Both groups: taking part in another clinical trial, unless the study's Executive Committee gives permission
Read by machine on 12 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.