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)
Prodromal Synucleinopathy Rating Scale — up to 5 years Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.
Trial sites (9)
Facility
City
Region
Status
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
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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.
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