ClinicalTrials.gov record NCT05826457

North American Prodromal Synucleinopathy Consortium Stage 2

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age18 years old and older

SexAll

LocationCanada, United States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study enrolls people with idiopathic REM sleep behavior disorder (RBD) and matched healthy controls. Across annual visits for up to five years, it collects clinical assessments, blood samples, brain imaging and other study data. RBD participants undergo two overnight sleep studies and may choose an optional lumbar puncture; control participants undergo lumbar puncture. The study prepares a trial-ready registry and data to support future studies of neuroprotective treatments for synucleinopathies.

What it is studying. The study seeks biomarkers and standardized data that identify early (prodromal) synucleinopathy in people with RBD and to create a registry ready for future neuroprotective trials.

What the researchers hope to learn. To develop and validate biomarkers for prodromal synucleinopathies and to build a standardized, trial-ready registry and dataset to support future neuroprotective clinical trials.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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

Exclusion criteria

for RBD Group
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
Inclusion Criteria for Control Group
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
Exclusion Criteria for Control Group
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.
Contraindications to complete MRI.
Contraindications to lumbar puncture.
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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

REM sleep behavior disorder (RBD) is a disorder where people act out their dreams. People with RBD often, but not always, develop Parkinson's Disease, dementia with Lewy bodies, multiple system atrophy, or other neurodegenerative diseases of the synucleinopathy type. The North American Prodromal Synucleinopathy Consortium Stage 2 (NAPS2) was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective trreatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and neuroimaging data. The RBD group will also undergo two overnight sleep studies. Some of this data will be used to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants. RBD group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI and DaTscan), polysomnogram (sleep study), and optional lumbar puncture. Control group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI), and lumbar puncture.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants have annual study visits for up to 5 years. People in the RBD group will have clinical assessments, questionnaires, blood draws, MRI and DaTscan imaging, two overnight sleep studies (polysomnograms), and may choose to have an optional lumbar puncture (spinal tap). Control participants will have clinical assessments, questionnaires, blood draws, MRI, and lumbar puncture. The study collects and stores clinical data, biofluids, and neuroimaging for research.

How the study is structured. A prospective, case-control observational study with two groups: a polysomnogram-confirmed idiopathic RBD group and matched healthy controls. Participants have annual visits for up to five years. RBD-group procedures include clinical assessments, questionnaires, blood draw, brain imaging (MRI and DaTscan), two overnight sleep studies (polysomnograms), and an optional lumbar puncture. Control-group procedures include clinical assessments, questionnaires, blood draw, brain MRI, and lumbar puncture.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says participants are enrolled by invitation. Who decides who is invited, and how?
The listed sites are in Canada, United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Aug 12, 2022
Primary completion: May 1, 2027 (estimated)
Study completion: May 1, 2028 (estimated)
Target enrollment: 500 participants (estimated)
Last updated on registry: May 13, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Washington University School of Medicine
Collaborators: Mayo Clinic
University of Minnesota
University of California, Los Angeles
McGill University
Emory University
Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Stanford University
National Institutes of Health (NIH)
Oregon Health and Science University
National Institute on Aging (NIA)

Participating sites (9)

Filter by country:

University of California Los Angeles
Los Angeles, California, 90095 · United States
Stanford University
Redwood City, California, 94063 · United States
Emory University
Atlanta, Georgia, 30322 · United States
Massachusetts General Hospital
Boston, Massachusetts, 02145 · United States
University of Minnesota
Minneapolis, Minnesota, 55414 · United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905 · United States
Washington University School of Medicine
St Louis, Missouri, 63110 · United States
Oregon Health Sciences University
Portland, Oregon, 97239 · United States
McGill University Health Centre Research Institute
Montreal, Quebec, H4A 3J1 · Canada

Terms used on this page · explanations by MedicalUpdates.ai

clinical trial: A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Control Group: The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
lumbar puncture: A procedure in which a needle is placed between the bones of the lower back to collect spinal fluid or to give a treatment.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Contraindications: A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
MRI: A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
biomarkers: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
registry: An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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