North American Prodromal Synucleinopathy Consortium Stage 2 (NAPS2)
This study is looking for people with REM sleep behavior disorder (RBD), a condition where you act out your dreams, and healthy volunteers. People with RBD often develop conditions like Parkinson's disease or Lewy body dementia later on. This study isn't testing a new treatment yet. Instead, it's preparing for future studies by collecting information like clinical assessments, blood samples, and brain scans (neuroimaging) from 500 participants. This data will help researchers understand synucleinopathies (a group of brain disorders) in their early stages and build a list of people who might be interested in future treatment trials. The main goal is to track changes using a scale called the Prodromal Synucleinopathy Rating Scale for up to five years.
- Study design
- This is an observational study, meaning no specific intervention is being tested. It plans to enroll 500 participants.
- What's involved
- If you have RBD, you would have a clinical assessment, fill out questionnaires, give blood, have brain scans (MRI and DaTscan), undergo two overnight sleep studies, and potentially a spinal tap (lumbar puncture). Healthy volunteers would have similar procedures, but only one MRI and an optional lumbar puncture.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years to measure changes on the Prodromal Synucleinopathy Rating Scale.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
North American Prodromal Synucleinopathy Consortium Stage 2
At a glance
Conditions
NCT05826457
Where you'd take part
This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Emory University
Atlanta, Georgiano site contact published
Massachusetts General Hospital
Boston, Massachusettsno site contact published
Mayo Clinic Rochester
Rochester, Minnesotano site contact published
McGill University Health Centre Research Institute
Montreal, Quebec, Canadano site contact published
Oregon Health Sciences University
Portland, Oregonno site contact published
Stanford University
Redwood City, Californiano site contact published
University of California Los Angeles
Los Angeles, Californiano site contact published
University of Minnesota
Minneapolis, Minnesotano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Yo-El Ju, MD, MCSI · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
- Brad Boeve, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
- Ron Postuma, MD · PRINCIPAL_INVESTIGATOR · McGill University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Prodromal Synucleinopathy Rating Scaleup 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.