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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623672
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2018
Last Update Posted : April 8, 2022
Sponsor:
Collaborators:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: North American Prodromal Synucleinopathy Consortium
Actual Study Start Date : August 29, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022





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

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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


Locations
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United States, Arizona
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Stanford University
Redwood City, California, United States, 94063
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02145
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239
Canada, Quebec
McGill University
Montréal, Quebec, Canada, HGH 2R9
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
Investigators
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Principal Investigator: Yo-El Ju, MD Washington University School of Medicine
Principal Investigator: Bradley Boeve, MD Mayo Clinic
Additional Information:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03623672    
Other Study ID Numbers: 201712025
R34AG056639 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
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

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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:
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Parkinson Disease
Dementia
Multiple System Atrophy
Shy-Drager Syndrome
Lewy Body Disease
REM Sleep Behavior Disorder
Synucleinopathies
Parasomnias
REM Sleep Parasomnias
Atrophy
Mental Disorders
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
Sleep Wake Disorders
Proteostasis Deficiencies
Metabolic Diseases