North American Prodromal Synucleinopathy Consortium

Last updated: November 4, 2024
Sponsor: Washington University School of Medicine
Overall Status: Active - Enrolling

Phase

N/A

Condition

Dementia

Sleep Disorders

Parkinson's With Dementia

Treatment

N/A

Clinical Study ID

NCT03623672
201712025
R34AG056639
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Idiopathic REM sleep behavior disorder

Exclusion

Exclusion Criteria:

  • REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia,Parkinson's Disease, etc)

  • Other neurological disorder

Study Design

Total Participants: 500
Study Start date:
August 29, 2018
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • McGill University

    Montréal, Quebec HGH 2R9
    Canada

    Site Not Available

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University

    Redwood City, California 94063
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02145
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Portland VA Medical Center

    Portland, Oregon 97239
    United States

    Site Not Available

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