Clinical trial NCT03623672: North American Prodromal Synucleinopathy Consortium
Official title: North American Prodromal Synucleinopathy Consortium
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: REM Sleep Behavior Disorder
Parkinson Disease
Lewy Body Disease
Dementia With Lewy Bodies
Multiple System Atrophy
REM Sleep Parasomnias
Keywords: sleep
REM
rapid eye movement
parkinson
lewy body disease
dementia with lewy bodies
Multiple System Atrophy
parasomnia
synuclein
synucleinopathy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: University of Minnesota
name: University of California, Los Angeles
name: McGill University
name: Emory University
name: Massachusetts General Hospital
name: National Institute on Aging (NIA)
name: Stanford University
name: Portland VA Medical Center
name: Banner Health
First posted: 2018-08-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Idiopathic REM sleep behavior disorder, adults.

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.

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.

Eligibility 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

Primary outcomes:
measure: Prodromal Synucleinopathy Rating Scale
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Washington University School of Medicine
name: Yo-El Ju, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Bradley Boeve, MD
role: PRINCIPAL_INVESTIGATOR
References: