North American Prodromal Synucleinopathy Consortium Stage 2

Last updated: November 4, 2024
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Disorders

Lewy Body Dementia

Dementia

Treatment

N/A

Clinical Study ID

NCT05826457
1234567
U19AG071754
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 500
Study Start date:
August 12, 2022
Estimated Completion Date:
May 01, 2025

Study 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.

Connect with a study center

  • McGill University Health Centre Research Institute

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Stanford University

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02145
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Oregon Health Sciences University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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