NCT05826457Enrolling by invitation
North American Prodromal Synucleinopathy Consortium Stage 2
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 8 Feb 2023
- Start date
- 12 Aug 2022
- Primary completion date
- 1 May 2027
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Lewy body dementia, Parkinson disease
- NCT number
- NCT05826457
What you commit to
- Study type: Observational
- Planned participants: 500
- From 12 Aug 2022 to the primary completion date, 1 May 2027
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Centre Research Institute Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Oregon Health Sciences University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Redwood City | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
Related publications
- The Prodromal Synucleinopathy Rating Scale: An Assessment in Patients With REM Sleep Behavior Disorder.Neurology · 2026 · PMID 42302227
- The North American Prodromal Synucleinopathy study: protocol for a multi-site, longitudinal, observational study of idiopathic/isolated rapid eye movement sleep behavior disorder.Sleep Adv · 2026 · PMID 41725984
This page is information, not medical advice. Discuss any trial with your doctor.