North American Prodromal Synucleinopathy Consortium

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.

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Key information

Conditions

REM Sleep Behavior Disorder Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Dementia With Lewy Bodies Lewy Body Disease Mental Disorders Metabolic Diseases Movement Disorders Multiple System Atrophy Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Parasomnias Parkinson Disease Parkinsonian Disorders Primary Dysautonomias Proteostasis Deficiencies REM Sleep Parasomnias Sleep Wake Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University, Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Acronym: NAPS

Important dates

Study start: 2018
Primary completion: 2026
Study completion: 2026
First posted: Aug 9, 2018
Registry last updated: Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation