North American Prodromal Synucleinopathy Consortium Stage 2
NCT ID: NCT05826457
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2022-08-12
2025-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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RBD group
Clinical observation involving annual visits to a study site for up to 5 years.
No interventions assigned to this group
control group
Clinical observation involving annual visits to a study site for up to 5 years.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Capable of providing informed consent at time of study enrollment
3. Age \> 18 years
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
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
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
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
University of Minnesota
OTHER
University of California, Los Angeles
OTHER
McGill University
OTHER
Emory University
OTHER
Massachusetts General Hospital
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Stanford University
OTHER
National Institutes of Health (NIH)
NIH
Oregon Health and Science University
OTHER
National Institute on Aging (NIA)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Yo-El Ju, MD, MCSI
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Brad Boeve, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Ron Postuma, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University
Locations
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University of California Los Angeles
Los Angeles, California, United States
Stanford University
Redwood City, California, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Oregon Health Sciences University
Portland, Oregon, United States
McGill University Health Centre Research Institute
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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1234567
Identifier Type: -
Identifier Source: org_study_id
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