COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

North American Prodromal Synucleinopathy Consortium (NAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03623672
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : July 16, 2020
Mayo Clinic
University of Minnesota
University of California, Los Angeles
McGill University
Emory University
Massachusetts General Hospital
National Institute on Aging (NIA)
Stanford University
Banner Health
Portland VA Medical Center
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease
REM Sleep Behavior Disorder Parkinson Disease Lewy Body Disease Dementia With Lewy Bodies Multiple System Atrophy REM Sleep Parasomnias

Detailed Description:
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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: North American Prodromal Synucleinopathy Consortium
Actual Study Start Date : August 29, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Primary Outcome Measures :
  1. Prodromal Synucleinopathy Rating Scale [ Time Frame: 2 years ]
    Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.

Biospecimen Retention:   Samples With DNA
Blood (plasma, buffy coat, extracted DNA) and cerebrospinal fluid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Idiopathic REM sleep behavior disorder, adults.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03623672

Layout table for location contacts
Contact: Yo-El Ju, MD 314-747-6124
Contact: Jennifer McLeland

Layout table for location information
United States, Arizona
Banner Sun Health Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact: Daneva MinerRose    623-832-5468   
Contact: Marissa Keane    623-832-6512   
Principal Investigator: David Shprecher, DO         
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Adreanne Rivera    310-794-0213   
Principal Investigator: Alon Avidan, MD         
Stanford University Recruiting
Redwood City, California, United States, 94063
Contact: Adrian Ekelmans    650-721-5489   
Principal Investigator: Emmanuel During, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kelsey Tucker    404-712-3529   
Principal Investigator: Daniel Huddleston, MD         
Sub-Investigator: Donald Bliwise, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02145
Contact: Matthew Stauder    617-726-9589   
Principal Investigator: Aleksandar Videnovic, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Josh De Kam    612-626-8052   
Principal Investigator: Michael Howell, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ruth Kraft    507-284-1324   
Principal Investigator: Bradley Boeve, MD         
Sub-Investigator: Erik St Louis, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jennifer McLeland    314-747-6124   
Principal Investigator: Yo-El Ju, MD         
United States, Oregon
Portland VA Medical Center Recruiting
Portland, Oregon, United States, 97239
Contact: Alisha McBride    503-220-8262 ext 5320   
Principal Investigator: Miranda Lim, MD, PhD         
Canada, Quebec
McGill University Recruiting
Montréal, Quebec, Canada, HGH 2R9
Contact: Amelie Pelletier    514-934-1934 ext 45462   
Principal Investigator: Ronald Postuma, MD         
Sponsors and Collaborators
Washington University School of Medicine
Mayo Clinic
University of Minnesota
University of California, Los Angeles
McGill University
Emory University
Massachusetts General Hospital
National Institute on Aging (NIA)
Stanford University
Banner Health
Portland VA Medical Center
Layout table for investigator information
Principal Investigator: Yo-El Ju, MD Washington University School of Medicine
Principal Investigator: Bradley Boeve, MD Mayo Clinic
Additional Information:

Layout table for additonal information
Responsible Party: Washington University School of Medicine Identifier: NCT03623672    
Other Study ID Numbers: 201712025
R34AG056639 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
rapid eye movement
lewy body disease
dementia with lewy bodies
Multiple System Atrophy
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Parkinson Disease
Lewy Body Disease
REM Sleep Behavior Disorder
REM Sleep Parasomnias
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Sleep Wake Disorders