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NCT03623672: NAPS

North American Prodromal Synucleinopathy Consortium

ENROLLING BY INVITATION Last updated 6 November 2024
What this trial tests

trial in REM Sleep Behavior Disorder in 500 participants. Enrolling by invitation.

Timeline
29 August 2018
Primary endpoint
31 July 2026
31 July 2026

Quick facts

Lead sponsorWashington University School of Medicine
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment500
Start date29 August 2018
Primary completion31 July 2026
Estimated completion31 July 2026
Sites10 locations across Canada, United States

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with REM Sleep Behavior Disorder or Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Biomarkers of conversion to α-synucleinopathy in isolated rapid-eye-movement sleep behaviour disorder.
    Miglis MG, Adler CH, Antelmi E, Arnaldi D, et al · · 2021 · cited 201× · PMID 34302789 · DOI 10.1016/s1474-4422(21)00176-9
  2. Frequency of Orthostatic Hypotension in Isolated REM Sleep Behavior Disorder.
    Elliott JE, Bryant-Ekstrand MD, Keil AT, Ligman BR, et al · · 2023 · cited 16× · PMID 37857496 · DOI 10.1212/wnl.0000000000207883
  3. Validation of the RBD Symptom Severity Scale in the North American Prodromal Synucleinopathy Consortium.
    Choudhury P, Lee-Iannotti JK, Busicescu AO, Rangan P, et al · · 2024 · cited 10× · PMID 38181331 · DOI 10.1212/wnl.0000000000208008
  4. Contemporary diagnostic visual and automated polysomnographic REM sleep without atonia thresholds in isolated REM sleep behavior disorder.
    Leclair-Visonneau L, Feemster JC, Bibi N, Gossard TR, et al · · 2024 · cited 10× · PMID 37823585 · DOI 10.5664/jcsm.10862
  5. "Janus-Faced" α-Synuclein: Role in Parkinson's Disease.
    Ray B, Mahalakshmi AM, Tuladhar S, Bhat A, et al · · 2021 · cited 7× · PMID 34124057 · DOI 10.3389/fcell.2021.673395
  6. A Narrative Review on Biochemical Markers and Emerging Treatments in Prodromal Synucleinopathies.
    Rissardo JP, Caprara ALF. · · 2025 · cited 5× · PMID 40136601 · DOI 10.3390/clinpract15030065
  7. IGLON5 Frequency in Idiopathic REM Sleep Behavior Disorder: A Multicenter Study.
    Postuma R, Vorasoot N, St Louis EK, Pelletier A, et al · · 2024 · cited 5× · PMID 39270144 · DOI 10.1212/nxi.0000000000200311

Verify or expand the search:

Other recruiting trials for REM Sleep Behavior Disorder

Currently open trials in the same condition.

Other Washington University School of Medicine trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03623672.

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