NAPS: North American Prodromal Synucleinopathy Consortium

Sponsor

Washington University School of Medicine (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03623672

Collaborator

Mayo Clinic (Other), University of Minnesota (Other), University of California, Los Angeles (Other), McGill University (Other), Emory University (Other), Massachusetts General Hospital (Other), National Institute on Aging (NIA) (NIH), Stanford University (Other), Banner Health (Other), Portland VA Medical Center (U.S. Fed)

500

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
REM Sleep Behavior Disorder Parkinson Disease Lewy Body Disease Dementia With Lewy Bodies Multiple System Atrophy REM Sleep Parasomnias

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

North American Prodromal Synucleinopathy Consortium

Actual Study Start Date :

Aug 29, 2018

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Sun Health Research Institute	Sun City	Arizona	United States	85351
2	University of California Los Angeles	Los Angeles	California	United States	90095
3	Stanford University	Redwood City	California	United States	94063
4	Emory University	Atlanta	Georgia	United States	30322
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02145
6	University of Minnesota	Minneapolis	Minnesota	United States	55455
7	Mayo Clinic	Rochester	Minnesota	United States	55905
8	Washington University	Saint Louis	Missouri	United States	63110
9	Portland VA Medical Center	Portland	Oregon	United States	97239
10	McGill University	Montréal	Quebec	Canada	HGH 2R9