North American Prodromal Synucleinopathy Consortium (NAPS)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease; Lewy Body Disease; Multiple System Atrophy; REM Sleep Behavior Disorder; Dementia With Lewy Bodies; 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
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, HGH 2R9
      • McGill University
• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research Institute
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Redwood City, California, United States, 94063
      • Stanford University
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Massachusetts
    • Boston, Massachusetts, United States, 02145
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Portland VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Idiopathic REM sleep behavior disorder, adults.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Massachusetts General Hospital; Mayo Clinic; McGill University; University of California, Los Angeles; Emory University; National Institute on Aging (NIA); Stanford University; University of Minnesota; Portland VA Medical Center; Banner Health
• Investigators: Principal Investigator: Yo-El Ju, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 29, 2018
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): July 31, 2022

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (ACTUAL): August 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: sleep; Multiple System Atrophy; parkinson; REM; rapid eye movement; lewy body disease; dementia with lewy bodies; parasomnia; synuclein; synucleinopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Proteostasis Deficiencies; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension; Parkinson Disease; Mental Disorders; Parasomnias; Dementia; Atrophy; Lewy Body Disease; Multiple System Atrophy; Shy-Drager Syndrome; Synucleinopathies; REM Sleep Behavior Disorder; REM Sleep Parasomnias
• Other Study ID Numbers: 201712025; R34AG056639 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data will be made available after primary analyses planned by NAPS investigators in 2020. Data will be available indefinitely.
• IPD Sharing Access Criteria: IPD and sample requests will be determined by a Steering Committee
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No