Observational study on REM sleep behavior disorder and neurodegenerative diseases
North American Prodromal Synucleinopathy Consortium Stage 2
This study is looking for people with REM sleep behavior disorder and healthy volunteers to help gather information that could lead to new treatments for certain brain diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 9 sites (Los Angeles, California and 8 other locations) |
| Trial ID | NCT05826457 on ClinicalTrials.gov |
What this trial studies
This study aims to enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls to prepare for a future clinical trial of neuroprotective treatments targeting synucleinopathies. Participants with RBD will undergo a series of assessments including clinical evaluations, questionnaires, blood draws, neuroimaging, and sleep studies. The data collected will help develop biomarkers for synucleinopathies in their early stages and create a registry of participants ready for future trials. The control group will also participate in similar assessments to provide comparative data.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with polysomnogram-confirmed REM sleep behavior disorder.
Not a fit: Patients with diagnosed Parkinson's Disease, dementia, or multiple system atrophy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of effective neuroprotective treatments for individuals at risk of developing neurodegenerative diseases.
How similar studies have performed: Other studies have shown promise in similar approaches, but this specific study is part of a novel initiative focused on prodromal synucleinopathies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 8 other locations
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- Stanford University — Redwood City, California, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
- Oregon Health Sciences University — Portland, Oregon, United States (Recruiting)
- McGill University Health Centre Research Institute — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Yo-El Ju, MD, MCSI — Washington University School of Medicine
- Study coordinator: Jennifer McLeland, PhD
- Email: mclelandj@wustl.edu
- Phone: 314-747-3819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.