Journal article
The North American Prodromal Synucleinopathy study: protocol for a multi-site, longitudinal, observational study of idiopathic/isolated rapid eye movement sleep behavior disorder
Sleep advances, Vol.7(1), zpag007
2026
DOI: 10.1093/sleepadvances/zpag007
PMCID: PMC12920605
PMID: 41725984
Abstract
Isolated/idiopathic rapid eye movement sleep behavior disorder (iRBD) is a usually prodromal manifestation of neurodegenerative disorders with α-synuclein pathology: Parkinson’s disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). Clinical trials in the iRBD population face substantial barriers: limited access to well-characterized cohorts, inconsistent assessment protocols across centers, and the absence of validated biomarkers of disease burden. The North American Prodromal Synucleinopathy (NAPS) Consortium was established to address these challenges and facilitate clinical trials for neuroprotective therapies targeting synucleinopathy at the earliest known stages. In this multi-site, longitudinal, observational study, nine academic centers across North America will enroll and follow over 500 individuals with iRBD from existing sleep centers. Sixty control participants, matched for age, sex, and race will also be recruited. A harmonized protocol—including a standardized clinical battery assessing motor, cognitive, autonomic, psychiatric, sensory, and sleep function; structured diagnostic adjudication; biospecimen collection; and centralized analysis of both polysomnography and neuroimaging data—is outlined herein and reflects NAPS Stage 2. Each participants completes these assessments annually, and are replaced in the event of phenoconversion. By unifying assessments and expanding geographic reach, NAPS lays the groundwork for efficient, well-powered clinical trials designed to delay or prevent progression of iRBD to overt PD, DLB, or MSA—ultimately enabling earlier, more effective therapeutic intervention for neurodegenerative disease. Registered at clinicaltrials.gov (NCT05826457).
Details
- Title: Subtitle
- The North American Prodromal Synucleinopathy study: protocol for a multi-site, longitudinal, observational study of idiopathic/isolated rapid eye movement sleep behavior disorder
- Creators
- Miranda M Lim - Oregon Health & Science UniversityLee E Neilson - University of IowaJonathan E Elliott - VA Portland Health Care SystemBianca Hoang-Dang - Oregon Health & Science UniversityJessica R Locke - Oregon Health & Science UniversityHannah Cunningham - Oregon Health & Science UniversityJessica Brewer - Oregon Health & Science UniversityLaura Dennis - Oregon Health & Science UniversityLaura Dovek - Oregon Health & Science UniversityAmélie Pelletier - Canadian Sleep & Circadian NetworkErik K St. Louis - Mayo ClinicStuart J McCarter - Mayo Clinic in ArizonaToji Miyagawa - Mayo Clinic in ArizonaAlbert A Davis - Washington University in St. LouisJennifer S McLeland - Washington University in St. LouisSusan Criswell - Barrow Neurological InstituteMichael J Howell - University of Minnesota Medical CenterCarlos H Schenck - University of Minnesota Medical CenterAlon Y Avidan - University of California, Los AngelesLynn Marie Trotti - Emory UniversityDonald L Bliwise - Emory UniversityDaniel E Huddleston - Emory UniversityAleksandar Videnovic - Mass General BrighamMitchell G Miglis - Stanford UniversityOliver Sum-Ping - Palo Alto UniversityJoyce K Lee-Iannotti - Barrow Neurological InstituteDavid R Shprecher - Banner Sun Health Research InstituteKevin Duff - Oregon Health & Science UniversityTanis J Ferman - Mayo Clinic in FloridaMeghan C Campbell - Washington University in St. LouisJulie A Fields - Mayo Clinic in ArizonaJean-François Gagnon - Université du Québec à MontréalPaul Kotzbauer - Washington University in St. LouisWolfgang Singer - Mayo Clinic in ArizonaZiv Gan-Or - Montreal Neurological Institute and HospitalOwen A Ross - Mayo Clinic in FloridaKejal Kantarci - Mayo Clinic in ArizonaVal J Lowe - Mayo Clinic in ArizonaXiaoping P Hu - University of California, RiversideMichele T Hu - Nuffield Orthopaedic CentreKaylena A Ehgoetz Martens - University of WaterlooChengjie Xiong - Washington University in St. LouisRonald B Postuma - Montreal Neurological Institute and HospitalBradley F Boeve - Mayo Clinic in ArizonaYo-El S Ju - Washington University in St. LouisNAPS Consortium for RBD
- Resource Type
- Journal article
- Publication Details
- Sleep advances, Vol.7(1), zpag007
- DOI
- 10.1093/sleepadvances/zpag007
- PMID
- 41725984
- PMCID
- PMC12920605
- NLM abbreviation
- Sleep Adv
- ISSN
- 2632-5012
- eISSN
- 2632-5012
- Publisher
- Oxford University Press
- Grant note
- NIH: R34 AG056639 (NAPS1) DoD CDMRP PRP: HT9425-24-1-0774
The research reported in this report was supported by NIH grants R34 AG056639 (NAPS1), U19 AG071754 (NAPS2), P50 AG016574, P30 AG062677, P30 AG066518, and U01 NS100620. DoD CDMRP PRP (HT9425-24-1-0774).
- Language
- English
- Date published
- 2026
- Academic Unit
- Neurology
- Record Identifier
- 9985139315902771
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