North American Prodromal Synucleinopathy Consortium (NAPS)

• ClinicalTrials.gov Identifier: NCT03623672
• Recruitment Status: Enrolling by invitation
• First Posted: August 9, 2018
• Last Update Posted: April 8, 2022
• Sponsor: Washington University School of Medicine
• Collaborators: Mayo Clinic; University of Minnesota; University of California, Los Angeles; McGill University; Emory University; Massachusetts General Hospital; National Institute on Aging (NIA); Stanford University; Banner Health; Portland VA Medical Center
• Information provided by (Responsible Party): Washington University School of Medicine

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
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]
• Estimated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Years
• Official Title: North American Prodromal Synucleinopathy Consortium
• Actual Study Start Date: August 29, 2018
• Estimated Primary Completion Date: July 31, 2022
• Estimated Study Completion Date: July 31, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Prodromal Synucleinopathy Rating Scale [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA

Blood (plasma, buffy coat, extracted DNA) and cerebrospinal fluid

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Idiopathic REM sleep behavior disorder, adults.

Criteria

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

United States, Arizona

Banner Sun Health Research Institute

Sun City, Arizona, United States, 85351

United States, California

University of California Los Angeles

Los Angeles, California, United States, 90095

Stanford University

Redwood City, California, United States, 94063

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02145

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

United States, Oregon

Portland VA Medical Center

Portland, Oregon, United States, 97239

Canada, Quebec

McGill University

Montréal, Quebec, Canada, HGH 2R9

Sponsors and Collaborators

Washington University School of Medicine

Mayo Clinic

University of Minnesota

University of California, Los Angeles

McGill University

Emory University

Massachusetts General Hospital

National Institute on Aging (NIA)

Stanford University

Banner Health

Portland VA Medical Center

Investigators

• Principal Investigator: Yo-El Ju, MD; Washington University School of Medicine
• Principal Investigator: Bradley Boeve, MD; Mayo Clinic

More Information

Additional Information:

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03623672
• Other Study ID Numbers: 201712025; R34AG056639 ( U.S. NIH Grant/Contract )
• First Posted: August 9, 2018
• Last Update Posted: April 8, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: This project will develop a large database of potential neurocognitive and polysomnographic biomarkers in rapid eye movement sleep behavior disorder (RBD), as well as a biobank of blood, DNA, and cerebrospinal fluid from individuals with RBD. Since individuals with RBD frequently develop synucleinopathies including Parkinson Disease, Dementia with Lewy Bodies (DLB), and Multiple System Atrophy, we anticipate that the data and samples we collect will be valuable for investigators interested in synucleinopathies, other dementias such as Alzheimer's Disease (AD), and sleep disorders. The neurocognitive battery will contain all components of the Uniform Dataset version 3 (UDS 3) with the additional DLB module, to harmonize with research efforts in AD and DLB. Biofluid samples will be banked at the National Cell Repository for Alzheimer's Disease (NCRAD) to facilitate distribution to other investigators.
• Supporting Materials: Study Protocol
• Time Frame: Data will be made available after primary analyses planned by NAPS investigators in 2020. Data will be available indefinitely.
• Access Criteria: IPD and sample requests will be determined by a Steering Committee
• URL: http://naps-rbd.org

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:

sleep; REM; rapid eye movement; parkinson; lewy body disease; dementia with lewy bodies; Multiple System Atrophy; parasomnia; synuclein; synucleinopathy

Additional relevant MeSH terms:

Parkinson Disease; Dementia; Multiple System Atrophy; Shy-Drager Syndrome; Lewy Body Disease; REM Sleep Behavior Disorder; Synucleinopathies; Parasomnias; REM Sleep Parasomnias; Atrophy; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Neurocognitive Disorders; Pathological Conditions, Anatomical; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Sleep Wake Disorders; Proteostasis Deficiencies; Metabolic Diseases