North American Prodromal Synucleinopathy Consortium
NAPS
2 other identifiers
observational
500
2 countries
10
Brief Summary
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.
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 2018
Longer than P75 for all trials
10 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
First Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedStudy Start
First participant enrolled
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
November 6, 2024
November 1, 2024
7.9 years
August 6, 2018
November 4, 2024
Conditions
Keywords
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.
2 years
Eligibility Criteria
Idiopathic REM sleep behavior disorder, adults.
You may qualify if:
- Idiopathic REM sleep behavior disorder
You may not qualify if:
- REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia, Parkinson's Disease, etc)
- Other neurological disorder
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 on Aging (NIA)collaborator
- Stanford Universitycollaborator
- Portland VA Medical Centercollaborator
- Banner Healthcollaborator
Study 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
Related Publications (2)
Postuma R, Vorasoot N, St Louis EK, Pelletier A, Lim MM, Elliott J, Gagnon JF, Gan-Or Z, Forsberg LK, Fields JA, Ross OA, Singer W, Huddleston DE, Bliwise DL, Avidan AY, Howell M, Schenck CH, McLeland J, Davis AA, Criswell SR, Videnovic A, During EH, Miglis MG, Boeve BF, Ju YS, McKeon A; as the North American Prodromal Synucleinopathy (NAPS) Consortium. IGLON5 Frequency in Idiopathic REM Sleep Behavior Disorder: A Multicenter Study. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200311. doi: 10.1212/NXI.0000000000200311. Epub 2024 Sep 13.
PMID: 39270144DERIVEDElliott JE, Bryant-Ekstrand MD, Keil AT, Ligman BR, Lim MM, Zitser J, During EH, Gagnon JF, St Louis EK, Fields JA, Huddleston DE, Bliwise DL, Avidan AY, Schenck CH, McLeland J, Criswell SR, Davis AA, Videnovic A, Lee-Iannotti JK, Postuma R, Boeve BF, Ju YS, Miglis MG; for North American Prodromal Synucleinopathy (NAPS) Consortium. Frequency of Orthostatic Hypotension in Isolated REM Sleep Behavior Disorder. Neurology. 2023 Dec 12;101(24):e2545-e2559. doi: 10.1212/WNL.0000000000207883. Epub 2023 Oct 19.
PMID: 37857496DERIVED
Biospecimen
Blood (plasma, buffy coat, extracted DNA) and cerebrospinal fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yo-El Ju, MD
Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Bradley Boeve, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2018
First Posted
August 9, 2018
Study Start
August 29, 2018
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
November 6, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be made available after primary analyses planned by NAPS investigators in 2020. Data will be available indefinitely.
- Access Criteria
- IPD and sample requests will be determined by a Steering Committee
This project will develop a large database of potential neurocognitive and polysomnographic biomarkers in rapid eye movement sleep behavior disorder (RBD), as well as a biobank of blood, DNA, and cerebrospinal fluid from individuals with RBD. Since individuals with RBD frequently develop synucleinopathies including Parkinson Disease, Dementia with Lewy Bodies (DLB), and Multiple System Atrophy, we anticipate that the data and samples we collect will be valuable for investigators interested in synucleinopathies, other dementias such as Alzheimer's Disease (AD), and sleep disorders. The neurocognitive battery will contain all components of the Uniform Dataset version 3 (UDS 3) with the additional DLB module, to harmonize with research efforts in AD and DLB. Biofluid samples will be banked at the National Cell Repository for Alzheimer's Disease (NCRAD) to facilitate distribution to other investigators.