By InvitationNot Applicable

North American Prodromal Synucleinopathy Consortium Stage 2

United States, Canada500 participantsStarted 2022-08-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Polysomnogram-confirmed RBD by ICSD-3 criteria
. Capable of providing informed consent at time of study enrollment
. Age \> 18 years

Exclusion criteria

. Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
. 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
. In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prodromal Synucleinopathy Rating Scale

Timeframe: up to 5 years

Trial details

NCT IDNCT05826457

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-05-01

View on ClinicalTrials.gov More REM Sleep Behavior Disorder trials