North American Prodromal Synucleinopathy Consortium

Parkinson Disease Clinical Trial

— NAPS  

Official title:

North American Prodromal Synucleinopathy Consortium

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03623672
• Other study ID #: 201712025
• Secondary ID: R34AG056639
• Status: Enrolling by invitation
• Start date: August 29, 2018
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease
• Mental Disorders
• Multiple System Atrophy
• Parasomnias
• Parkinson Disease
• REM Sleep Behavior Disorder
• REM Sleep Parasomnias
• Shy-Drager Syndrome

Locations

Country	Name	City	State
Canada	McGill University	Montréal	Quebec
United States	Emory University	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of California Los Angeles	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Portland VA Medical Center	Portland	Oregon
United States	Stanford University	Redwood City	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	Banner Sun Health Research Institute	Sun City	Arizona

Sponsors (11)

Lead Sponsor	Collaborator
Washington University School of Medicine	Banner Health, Emory University, Massachusetts General Hospital, Mayo Clinic, McGill University, National Institute on Aging (NIA), Portland VA Medical Center, Stanford University, University of California, Los Angeles, University of Minnesota

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prodromal Synucleinopathy Rating Scale	Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.	2 years