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NCT05826457Enrolling by invitation

North American Prodromal Synucleinopathy Consortium Stage 2

Source: ClinicalTrials.gov · Last updated 13 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
500 (estimated)
First submitted
8 Feb 2023
Start date
12 Aug 2022
Primary completion date
1 May 2027
Lead sponsor
Washington University School of Medicine
NCT number
NCT05826457

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 12 Aug 2022 to the primary completion date, 1 May 2027
  • 9 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.

Other illness

  • In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
  • History of dream enactment behavior to suggest RBD
  • Parkinsonism, MSA, dementia, or mild cognitive impairment
  • Active central nervous system, systemic, psychiatric condition or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning.
  • In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol

Other

  • Narcolepsy-associated RBD
  • RBD secondary to any known cause except prodromal synucleinopathy.
  • Participation in a clinical trial, except by specific permission by the Executive Committee
  • Contraindications to complete MRI.
  • Contraindications to lumbar puncture.
  • Participation in a clinical trial, except by specific permission by the Executive Committee

Who the study is looking for

  • Polysomnogram-confirmed RBD by ICSD-3 criteria
  • Capable of providing informed consent at time of study enrollment
  • Age \> 18 years
  • Ability to provide written consent
  • Age \> 18 years
  • Must meet age, sex, and race matching criteria per the Data Management and Statistical core recommendations for the site
  • Must be willing to undergo all testing procedures, including neuroimaging and lumbar puncture.
  • Normal capacity to perform complex activities of daily living independently based on informant or physician report

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McGill University Health Centre Research Institute
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Emory University
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AtlantaUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
University of California, Los Angeles
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
Oregon Health Sciences University
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Stanford University
Coordinator of this site? Confirm its status
Redwood CityUnited StatesUnknown status
Mayo Clinic - Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.