North American Prodromal Synucleinopathy Consortium Stage 2

Recruiting

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

• Registration Number: NCT05826457
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.

Detailed Description

REM sleep behavior disorder (RBD) is a 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 Consortium Stage 2 (NAPS2) was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective trreatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and neuroimaging data. The RBD group will also undergo two overnight sleep studies. Some of this data will be used to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants.

RBD group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI and DaTscan), polysomnogram (sleep study), and optional lumbar puncture.

Control group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI), and lumbar puncture.

Study Timeline

• Study Start: 2022-08-12
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-04-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prodromal Synucleinopathy Rating Scale	up to 5 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 (9)

Emory University; 🇺🇸 Atlanta, Georgia, United States

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

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

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

McGill University Health Centre Research Institute; 🇨🇦 Montréal, Quebec, Canada

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

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