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NCT03623672: NAPS
North American Prodromal Synucleinopathy Consortium
trial in REM Sleep Behavior Disorder in 500 participants. Enrolling by invitation.
31 July 2026
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 29 August 2018 |
| Primary completion | 31 July 2026 |
| Estimated completion | 31 July 2026 |
| Sites | 10 locations across Canada, United States |
Conditions studied
- REM Sleep Behavior Disorder — all drugs for REM Sleep Behavior Disorder →
- Parkinson Disease — all drugs for Parkinson Disease →
- Lewy Body Disease — all drugs for Lewy Body Disease →
- Dementia With Lewy Bodies — all drugs for Dementia With Lewy Bodies →
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):
-
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 -
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 -
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 -
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 -
"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 -
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 -
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:
- PubMed search for NCT03623672
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for REM Sleep Behavior Disorder
Currently open trials in the same condition.
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- NCT07443293 — IMPACT 360 for Parkinson's Disease · Phase 2 · recruiting
- NCT06629207 — Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder · NA · recruiting
- NCT06441864 — Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder · NA · recruiting
- NCT06270290 — The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls · recruiting
Other Washington University School of Medicine trials
Trials by the same sponsor.
- NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
- NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
- NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
- NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
- NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03623672 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
- Last refreshed: 6 November 2024
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing