Parkinson Disease Clinical Trial
— NAPS2Official title:
North American Prodromal Synucleinopathy Consortium Stage 2
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 | Recruiting |
Enrollment | 500 |
Est. completion date | May 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre Research Institute | Montréal | Quebec |
United States | Emory University | Atlanta | Georgia |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of California Los Angeles | Los Angeles | California |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Oregon Health Sciences University | Portland | Oregon |
United States | Stanford University | Redwood City | California |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Emory University, Massachusetts General Hospital, Mayo Clinic, McGill University, National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), National Institutes of Health (NIH), Oregon Health and Science University, Stanford University, University of California, Los Angeles, University of Minnesota |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prodromal Synucleinopathy Rating Scale | Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy. | up to 5 years |
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