Evidence map›Paper›PMID 41725984›Full record

ArticleSleep advances : a journal of the Sleep Research Society2026

The North American Prodromal Synucleinopathy study: protocol for a multi-site, longitudinal, observational study of idiopathic/isolated rapid eye movement sleep behavior disorder.

Miranda M Lim, Lee E Neilson, Jonathan E Elliott, Bianca Hoang-Dang, Jessica R Locke, Hannah Cunningham, Jessica Brewer, Laura Dennis, Laura Dovek, Amélie Pelletier and 36 more

Registry-linked trialAbstract read
In one paragraph

Article in Sleep advances : a journal of the Sleep Research Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05826457 (North American Prodromal Synucleinopathy Consortium Stage 2), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05826457 enrolling by invitationnot on this map

North American Prodromal Synucleinopathy Consortium Stage 2

TypeobservationalSponsorWashington University School of MedicineRan2022 to 2028Enrolled500ConditionsREM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Dementia, Dementia With Lewy Bodies
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

46 authors.

Miranda M LimResearch Service, VA Portland Health Care System, Portland, OR, United States.ORCID https://orcid.org/0000-0003-3876-3196
Lee E NeilsonResearch Service, VA Portland Health Care System, Portland, OR, United States.ORCID https://orcid.org/0000-0002-1866-0344
Jonathan E ElliottResearch Service, VA Portland Health Care System, Portland, OR, United States.ORCID https://orcid.org/0000-0002-6992-6851
Bianca Hoang-DangDepartment of Neurology, Oregon Health and Science University, Portland, OR, United States.
Jessica R LockeResearch Service, VA Portland Health Care System, Portland, OR, United States.
Hannah CunninghamDepartment of Neurology, Oregon Health and Science University, Portland, OR, United States.ORCID https://orcid.org/0000-0001-5093-1741
Jessica BrewerDepartment of Neurology, Oregon Health and Science University, Portland, OR, United States.
Laura DennisResearch Service, VA Portland Health Care System, Portland, OR, United States.
Laura DovekResearch Service, VA Portland Health Care System, Portland, OR, United States.
Amélie PelletierDepartment of Neurology and Neurosurgery, The Neuro (Montreal Neurological Institute-Hospital), McGill University, Montreal QC, Canada.
Erik K St LouisDepartment of Neurology, Mayo Clinic, Rochester, MN, United States.ORCID https://orcid.org/0000-0002-2833-8826
Stuart J McCarterDepartment of Neurology, Mayo Clinic, Rochester, MN, United States.
Toji MiyagawaDepartment of Neurology, Mayo Clinic, Rochester, MN, United States.
Albert A DavisDepartment of Neurology, Washington University School of Medicine, Saint Louis, MO, United States.
Jennifer S McLelandDepartment of Neurology, Washington University School of Medicine, Saint Louis, MO, United States.
Susan CriswellDepartment of Neurology, Barrow Neurological Institute, Phoenix, AZ, United States.ORCID https://orcid.org/0000-0001-8467-371X
Michael J HowellDepartment of Neurology, University of Minnesota Medical School, Minneapolis, MN, United States.
Carlos H SchenckDepartment of Psychiatry, University of Minnesota Medical School, Minneapolis, MN, United States.ORCID https://orcid.org/0000-0002-0095-2680
Alon Y AvidanDepartment of Neurology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, United States.ORCID https://orcid.org/0000-0002-8817-6590
Lynn Marie TrottiDepartment of Neurology, Emory University, Atlanta, GA, United States.ORCID https://orcid.org/0000-0003-2329-6847
Donald L BliwiseDepartment of Neurology, Emory University, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-5079-035X
Daniel E HuddlestonDepartment of Neurology, Emory University, Atlanta, GA, United States.ORCID https://orcid.org/0000-0003-0503-3736
Aleksandar VidenovicDepartment of Neurology, Mass General Brigham, Boston, MA, United States.
Mitchell G MiglisDepartment of Neurology and Neurological Sciences, Stanford University, Palo Alto, CA, United States.ORCID https://orcid.org/0000-0001-8488-0313
Oliver Sum-PingDepartment of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, United States.
Joyce K Lee-IannottiDepartment of Neurology, Barrow Neurological Institute, Phoenix, AZ, United States.
David R ShprecherDepartment of Neurology, Banner Sun Health Research Institute, Sun City, AZ, United States.
Kevin DuffDepartment of Neurology, Oregon Health and Science University, Portland, OR, United States.ORCID https://orcid.org/0000-0002-9336-2400
Tanis J FermanDepartment of Psychiatry and Psychology, Mayo Clinic, Jacksonville, FL, United States.
Meghan C CampbellDepartment of Neurology, Washington University School of Medicine, Saint Louis, MO, United States.
Julie A FieldsDepartment of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, United States.
Jean-François GagnonDepartment of Psychology, Université du Québec à Montréal, Montreal QC, Canada.
Paul KotzbauerDepartment of Neurology, Washington University School of Medicine, Saint Louis, MO, United States.
Wolfgang SingerDepartment of Neurology, Mayo Clinic, Rochester, MN, United States.ORCID https://orcid.org/0000-0003-1263-6850
Ziv Gan-OrDepartment of Neurology and Neurosurgery, The Neuro (Montreal Neurological Institute-Hospital), McGill University, Montreal QC, Canada.ORCID https://orcid.org/0000-0003-0332-234X
Owen A RossDepartment of Neuroscience, Mayo Clinic, Jacksonville, FL, United States.ORCID https://orcid.org/0000-0003-4813-756X
Kejal KantarciDepartment of Radiology, Mayo Clinic, Rochester, MN, United States.ORCID https://orcid.org/0000-0002-8001-2081
Val J LoweDepartment of Radiology, Mayo Clinic, Rochester, MN, United States.
Xiaoping P HuCenter for Advanced Neuroimaging, Department of Bioengineering, University of California, Riverside, CA, United States.
Kaylena A Ehgoetz MartensDepartment of Kinesiology and Health Sciences, University of Waterloo, Waterloo, ON, Canada.
Michele T HuNuffield Department of Clinical Neurosciences, Division of Neurology, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0001-6382-5841
Chengjie XiongCenter for Biostatistics and Data Science, Washington University School of Medicine, Saint Louis, MO, United States.
Ronald B PostumaDepartment of Neurology and Neurosurgery, The Neuro (Montreal Neurological Institute-Hospital), McGill University, Montreal QC, Canada.
Bradley F BoeveDepartment of Neurology, Mayo Clinic, Rochester, MN, United States.ORCID https://orcid.org/0000-0002-4153-8187
Yo-El S JuDepartment of Neurology, Washington University School of Medicine, Saint Louis, MO, United States.
NAPS Consortium for RBD

Funding

Project: Predicting PhenoconversionU19AG071754 · NIA · WASHINGTON UNIVERSITY · PI Bradley F Boeve, Yo-El S Ju · 2021 to 2026
$41.2M
THE PGRN/TDP-43 AXIS IN ALZHEIMER?S DISEASE AND NEURODEGENERATIONP50AG016574 · NIA · MAYO CLINIC ROCHESTER · PI PETERSEN, RONALD C · 1999 to 2018
$36.9M
Research Education ComponentP30AG062677 · NIA · MAYO CLINIC ROCHESTER · PI KEJAL KANTARCI · 2019 to 2026
$33.5M
Research Education ComponentP30AG066518 · NIA · OREGON HEALTH & SCIENCE UNIVERSITY · PI KEVIN M DUFF, Lisa C Silbert · 2020 to 2026
$28.6M
Longitudinal Imaging Biomarkers of Prodromal DLBU01NS100620 · NINDS · MAYO CLINIC ROCHESTER · PI Bradley F Boeve, KEJAL KANTARCI · 2017 to 2026
$19.2M
Neuroprotective Treatment Trial Planning in REM Sleep Behavior DisorderR34AG056639 · NIA · WASHINGTON UNIVERSITY · PI BOEVE, BRADLEY F, JU, YO-EL S · 2018 to 2019
$1.2M
BLRD VA I01 BX006155CSRD VA I01 CX002022NIA NIH HHS P30 AG062677NIA NIH HHS P30 AG066518NIA NIH HHS P50 AG016574NIA NIH HHS R34 AG056639NIA NIH HHS U19 AG071754NINDS NIH HHS U01 NS100620
6 · The paper itself

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).

Indexed as

clinical trial protocolLewy body diseaseneurodegenerative diseasesParkinson diseaseprodromal symptomsREM sleep behavior disordersynucleinopathies

Identifiers

PMID41725984
PMCPMC12920605

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.