ClinicalTrials.gov record NCT03623672
North American Prodromal Synucleinopathy Consortium
North American Prodromal Synucleinopathy Consortium
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 prospective observational study enrolls adults with idiopathic REM sleep behavior disorder (RBD) — it excludes RBD secondary to another cause (for example narcolepsy, dementia, Parkinson's Disease) and other neurological disorders. The study collects standardized clinical assessments, questionnaires, blood samples, and at some sites an optional lumbar puncture to build a trial-ready registry. Participants are followed over time (target duration about 3 years).
What it is studying. Collecting clinical and biological data to develop biomarkers of prodromal synucleinopathies and to create a registry of people with idiopathic RBD for future neuroprotective trials.
What the researchers hope to learn. To collect standardized clinical assessments and biofluids, develop biomarkers for prodromal synucleinopathies, and build a trial-ready participant registry 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 rapid eye movement (REM) sleep behavior disorder (RBD), 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
- Idiopathic REM sleep behavior disorder
Exclusion criteria
- REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia, Parkinson's Disease, etc)
- Other neurological disorder
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 rare 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 (NAPS) Consortium was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective treatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and other data in order to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants. Participants procedures will include a ~2-hour clinical assessment (medical history and physical exam), questionnaires, blood draw, and (at select sites) optional 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 will have a roughly 2-hour clinical visit including medical history and a physical exam, complete questionnaires, and give blood samples. The study collects standardized clinical data and biofluids and follows participants over time (target duration about 3 years). At select sites, an optional lumbar puncture (spinal tap) may be offered. Participation involves these assessments and sample collections; other procedures are not specified in the registry record.
How the study is structured. A prospective observational cohort study: people with idiopathic RBD are followed over time (target about 3 years) with standardized clinical assessments and sample collection; no experimental treatment is given.
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
Important dates
- Study start
- Aug 29, 2018
- Primary completion
- Jul 31, 2026 (estimated)
- Study completion
- Jul 31, 2026 (estimated)
- Target enrollment
- 500 participants (estimated)
- Last updated on registry
- Nov 6, 2024
- 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 on Aging (NIA)
- Stanford University
- Portland VA Medical Center
- Banner Health
Participating sites (10)
- Banner Sun Health Research Institute
Sun City, Arizona, 85351 · United States
- 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, 55455 · United States
- Mayo Clinic
Rochester, Minnesota, 55905 · United States
- Washington University
St Louis, Missouri, 63110 · United States
- Portland VA Medical Center
Portland, Oregon, 97239 · United States
- McGill University
Montreal, Quebec, HGH 2R9 · 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.
- 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.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- 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.
- 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.
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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