Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Alon Avidan, MD, MPH
Headshot of Alon Avidan
Alon Avidan

Description

Summary

This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.

Details

REM sleep behavior disorder (RBD) is a 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 Consortium Stage 2 (NAPS2) was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective trreatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and neuroimaging data. The RBD group will also undergo two overnight sleep studies. Some of this data will be used to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants.

RBD group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI and DaTscan), polysomnogram (sleep study), and optional lumbar puncture.

Control group procedures include a clinical assessment, questionnaires, blood draw, neuroimaging (MRI), and lumbar puncture.

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

for RBD Group

1. Polysomnogram-confirmed RBD by ICSD-3 criteria 2. Capable of providing informed consent at time of study enrollment 3. Age > 18 years

You CAN'T join if...

for RBD Group

1. Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1. 2. Narcolepsy-associated RBD 3. RBD secondary to any known cause except prodromal synucleinopathy. 4. Participation in a clinical trial, except by specific permission by the Executive Committee 5. In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol Inclusion Criteria for Control Group 1. Ability to provide written consent 2. Age > 18 years 3. Must meet age, sex, and race matching criteria per the Data Management and Statistical core recommendations for the site 4. Must be willing to undergo all testing procedures, including neuroimaging and lumbar puncture. 5. Normal capacity to perform complex activities of daily living independently based on informant or physician report Exclusion Criteria for Control Group 1. History of dream enactment behavior to suggest RBD 2. Parkinsonism, MSA, dementia, or mild cognitive impairment 3. Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning. 4. Contraindications to complete MRI. 5. Contraindications to lumbar puncture. 6. Participation in a clinical trial, except by specific permission by the Executive Committee 7. In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol

Locations

  • University of California Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • Stanford University not yet accepting patients
    Redwood City California 94063 United States
  • Oregon Health Sciences University accepting new patients
    Portland Oregon 97239 United States
  • University of Minnesota accepting new patients
    Minneapolis Minnesota 55414 United States

Lead Scientist at UCLA

  • Alon Avidan, MD, MPH
    Alon. Y. Avidan, MD, MPH, FAAN, FAASM Dr. Avidan is a Professor of Neurology at UCLA where he serves as Director of the UCLA Sleep Disorders Center. He completed his Neurology Residency at the Georgetown University Medical Center, and Fellowship in Sleep Medicine at the Cleveland Clinic.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Washington University School of Medicine
Links
Sign up for this study
ID
NCT05826457
Study Type
Observational
Participants
Expecting 500 study participants
Last Updated