North American Prodromal Synucleinopathy Consortium

• Conditions: Parkinson Disease; REM Sleep Parasomnias; REM Sleep Behavior Disorder; Dementia With Lewy Bodies; Multiple System Atrophy; Lewy Body Disease

• Registration Number: NCT03623672
• Lead Sponsor: Washington University School of Medicine

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 Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Study Start: 2018-08-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prodromal Synucleinopathy Rating Scale	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.

Trial Locations

Locations (10)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Stanford University; 🇺🇸 Redwood City, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

McGill University; 🇨🇦 Montréal, Quebec, Canada