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North American Prodromal Synucleinopathy Consortium (NAPS)

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ClinicalTrials.gov Identifier: NCT03623672
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
University of California, Los Angeles
McGill University
Emory University
Massachusetts General Hospital
National Institute on Aging (NIA)
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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: North American Prodromal Synucleinopathy Consortium
Estimated Study Start Date : August 1, 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


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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03623672


Contacts
Contact: Yo-El Ju, MD 314-747-6124 info@naps-rbd.org
Contact: Jennifer McLeland naps@wustl.edu

Locations
United States, California
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Amanda Gonzales    310-825-0703    amgonzales@mednet.ucla.edu   
Principal Investigator: Alon Avidan, MD         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Cathy Wood-Siverio    404-712-6988    cwoodsi@emory.edu   
Principal Investigator: Daniel Huddleston, MD         
Sub-Investigator: Donald Bliwise, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02145
Contact: Jessica Tran    617-724-2644    jtran20@mgh.harvard.edu   
Principal Investigator: Aleksandar Videnovic, MD         
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Michael Howell, MD    612-624-9025    howel020@umn.edu   
Principal Investigator: Michael Howell, MD         
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Ruth Kraft    507-284-1324    kraft.ruth@mayo.edu   
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    naps@wustl.edu   
Principal Investigator: Yo-El Ju, MD         
Canada, Quebec
McGill University Not yet recruiting
Montréal, Quebec, Canada, HGH 2R9
Contact: Amelie Pelletier    514-934-1934 ext 45462    amelie.pelletier@mail.mcgill.ca   
Principal Investigator: Ronald Postuma, MD         
Sponsors and Collaborators
Washington University School of Medicine
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
University of California, Los Angeles
McGill University
Emory University
Massachusetts General Hospital
National Institute on Aging (NIA)
Investigators
Principal Investigator: Yo-El Ju, MD Washington University School of Medicine
Principal Investigator: Bradley Boeve, MD Mayo Clinic

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03623672     History of Changes
Other Study ID Numbers: 201712025
R34AG056639 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
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
URL: http://naps-rbd.org

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:
sleep
REM
rapid eye movement
parkinson
lewy body disease
dementia with lewy bodies
Multiple System Atrophy
parasomnia
synuclein
synucleinopathy

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Atrophy
Mental Disorders
Multiple System Atrophy
Shy-Drager Syndrome
Lewy Body Disease
REM Sleep Behavior Disorder
Parasomnias
Sleep Wake Disorders
REM Sleep Parasomnias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms