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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 : July 3, 2019
Sponsor:
Collaborators:
Mayo Clinic
University of Minnesota
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

Tracking Information
First Submitted Date August 6, 2018
First Posted Date August 9, 2018
Last Update Posted Date July 3, 2019
Actual Study Start Date August 29, 2018
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2018)
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.
Original Primary Outcome Measures
 (submitted: August 6, 2018)
  • Prodromal Synucleinopathy Rating Scale [ Time Frame: 2 years ]
    Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision, functions
  • REM sleep without atonia (RSWA) [ Time Frame: 2 years ]
    Quantified RSWA
  • Cerebrospinal fluid alpha-synuclein Real-time quaking-induced conversion [ Time Frame: 2 years ]
    RT-QuIC seeded with human recombinant alpha-synuclein
Change History Complete list of historical versions of study NCT03623672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title North American Prodromal Synucleinopathy Consortium
Official Title North American Prodromal Synucleinopathy Consortium
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.
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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:
Blood (plasma, buffy coat, extracted DNA) and cerebrospinal fluid
Sampling Method Non-Probability Sample
Study Population Idiopathic REM sleep behavior disorder, adults.
Condition
  • REM Sleep Behavior Disorder
  • Parkinson Disease
  • Lewy Body Disease
  • Dementia With Lewy Bodies
  • Multiple System Atrophy
  • REM Sleep Parasomnias
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 6, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yo-El Ju, MD 314-747-6124 info@naps-rbd.org
Contact: Jennifer McLeland naps@wustl.edu
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03623672
Other Study ID Numbers 201712025
R34AG056639 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators
  • Mayo Clinic
  • University of Minnesota
  • 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
PRS Account Washington University School of Medicine
Verification Date July 2019