North American Prodromal Synucleinopathy Consortium Stage 2
NAPS2
2 other identifiers
observational
500
2 countries
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2022
CompletedFirst Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedNovember 6, 2024
November 1, 2024
2.7 years
February 8, 2023
November 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Prodromal Synucleinopathy Rating Scale
Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.
up to 5 years
Study Arms (2)
RBD group
Clinical observation involving annual visits to a study site for up to 5 years.
control group
Clinical observation involving annual visits to a study site for up to 5 years.
Eligibility Criteria
Idiopathic REM sleep behavior disorder, adults.
You may qualify if:
- Polysomnogram-confirmed RBD by ICSD-3 criteria
- Capable of providing informed consent at time of study enrollment
- Age \> 18 years
You may not qualify if:
- 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
- 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
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Mayo Cliniccollaborator
- University of Minnesotacollaborator
- University of California, Los Angelescollaborator
- McGill Universitycollaborator
- Emory Universitycollaborator
- Massachusetts General Hospitalcollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- Stanford Universitycollaborator
- National Institutes of Health (NIH)collaborator
- Oregon Health and Science Universitycollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (9)
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
Biospecimen
Serum, plasma, buffy coat, paxgene, and cerebral spinal fluid.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yo-El Ju, MD, MCSI
Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Brad Boeve, MD
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Ron Postuma, MD
McGill University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2023
First Posted
April 24, 2023
Study Start
August 12, 2022
Primary Completion
May 1, 2025
Study Completion
May 1, 2025
Last Updated
November 6, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Updated datasets will be made available after completion of each semiannual data cleaning and data freeze. De-identified data will be available for at least the duration of the NAPS2 study.
- Access Criteria
- The NAPS2 Administrative Core will receive, process, and track all requests for data/biospecimens. All requests will be reviewed and tracked per the current NAPS Data Access Policy (https://www.naps-rbd.org/resources at the bottom of the webpage) at the time of request. Approved requests will be filled using data that has been de-identified.
De-identified subject level data will be shared upon approved data request. This project will develop a large database of potential neurocognitive, neuroimaging, genetic, and polysomnographic biomarkers in rapid eye movement sleep behavior disorder (RBD), as well as a biobank of blood, DNA, RNA, and cerebrospinal fluid. A large part of the clinical battery is the Uniform Dataset version 3, will be uploaded to the National Alzheimer's Coordinating Center (NACC). Biofluid samples will be banked at the National Cell Repository for Alzheimer's Disease (NCRAD). Genetic data will be submitted to the National Institute on Aging Genetics of Alzheimer's Disease Data Storage (NIAGADS). Brain MRI and DaTscan imaging data will be uploaded to the Laboratory of NeuroImaging (LONI). Polysomnogram data will be uploaded to the National Sleep Research Resource (NSRR).