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Clinical Trials in Canada / NCT05826457
Enrolling by invitation Observational

North American Prodromal Synucleinopathy Consortium Stage 2

NCT05826457 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2022-08-12
Last updated
2026-05-13

Condition(s) studied

REM Sleep Behavior DisorderParkinson DiseaseLewy Body DementiaDementia With Lewy BodiesMultiple System AtrophyREM Sleep Parasomnias

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 complex activities of daily living independently based on informant or physician report Exclusion Criteria for Control Group 1. History of dream enactment behavior to suggest RBD 2. Parkinsonism, MSA, dementia, or mild cognitive impairment 3. Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning. 4. Contraindications to complete MRI. 5. Contraindications to lumbar puncture. 6. Participation in a clinical trial, except by specific permission by the Executive Committee 7. In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
University of California Los Angeles Los Angeles California
Stanford University Redwood City California
Emory University Atlanta Georgia
Massachusetts General Hospital Boston Massachusetts
University of Minnesota Minneapolis Minnesota
Mayo Clinic Rochester Rochester Minnesota
Washington University School of Medicine St Louis Missouri
Oregon Health Sciences University Portland Oregon
McGill University Health Centre Research Institute Montreal Quebec

More Washington University School of Medicine trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05826457 on ClinicalTrials.gov ↗ ← All trials in Canada