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NCT05826457 | RECRUITING | REM Sleep Behavior Disorder

North American Prodromal Synucleinopathy Consortium Stage 2
Sponsor:

Washington University School of Medicine

Brief 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.

Condition or disease

REM Sleep Behavior Disorder

Parkinson Disease

Lewy Body Dementia

Dementia With Lewy Bodies

Multiple System Atrophy

REM sleep parasomnias

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : North American Prodromal Synucleinopathy Consortium Stage 2
Actual Study Start Date : 2022-08-12
Estimated Primary Completion Date : 2025-05-01
Estimated Study Completion Date : 2025-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria 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
    • Exclusion Criteria 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
    • North American Prodromal Synucleinopathy Consortium Stage 2

    Location Details

    NCT05826457

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, California

    University of California Los Angeles

    Los Angeles, California, United States, 90095

    RECRUITING

    United States, California

    Stanford University

    Redwood City, California, United States, 94063

    RECRUITING

    United States, Georgia

    Emory University

    Atlanta, Georgia, United States, 30322

    RECRUITING

    United States, Massachusetts

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02145

    RECRUITING

    United States, Minnesota

    University of Minnesota

    Minneapolis, Minnesota, United States, 55414

    RECRUITING

    United States, Minnesota

    Mayo Clinic Rochester

    Rochester, Minnesota, United States, 55905

    RECRUITING

    United States, Missouri

    Washington University School of Medicine

    St Louis, Missouri, United States, 63110

    RECRUITING

    United States, Oregon

    Oregon Health Sciences University

    Portland, Oregon, United States, 97239

    RECRUITING

    Canada, Quebec

    McGill University Health Centre Research Institute

    Montreal, Quebec, Canada, H4A 3J1