NAPS2: North American Prodromal Synucleinopathy Consortium Stage 2
Study Details
Study Description
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 | Intervention/Treatment | Phase |
---|---|---|
|
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
RBD Group Clinical observation involving annual visits to a study site for up to 5 years. |
|
Control Group Clinical observation involving annual visits to a study site for up to 5 years. |
Outcome Measures
Primary Outcome Measures
- Prodromal Synucleinopathy Rating Scale [up to 5 years]
Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.
Eligibility Criteria
Criteria
Inclusion Criteria for RBD Group
-
Polysomnogram-confirmed RBD by ICSD-3 criteria
-
Capable of providing informed consent at time of study enrollment
-
Age > 18 years
Exclusion Criteria for RBD Group
-
Diagnosis of PD, dementia of any type, or MSA unless previous participant in NAPS1.
-
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
-
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
-
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
Exclusion Criteria for Control Group
-
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.
-
Contraindications to complete MRI.
-
Contraindications to lumbar puncture.
-
Participation in a clinical trial, except by specific permission by the Executive Committee
-
In the opinion of the investigator, the individual has a clinically significant uncontrolled medical condition that would impede safe completion of the study protocol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of California Los Angeles | Los Angeles | California | United States | 90095 |
2 | Stanford University | Redwood City | California | United States | 94063 |
3 | Emory University | Atlanta | Georgia | United States | 30322 |
4 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02145 |
5 | University of Minnesota | Minneapolis | Minnesota | United States | 55414 |
6 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55905 |
7 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
8 | Oregon Health Sciences University | Portland | Oregon | United States | 97239 |
9 | McGill University Health Centre Research Institute | Montréal | Quebec | Canada | H4A 3J1 |
Sponsors and Collaborators
- Washington University School of Medicine
- Mayo Clinic
- University of Minnesota
- University of California, Los Angeles
- McGill University
- Emory University
- Massachusetts General Hospital
- National Institutes of Health (NIH)
- National Institute of Neurological Disorders and Stroke (NINDS)
- Stanford University
- Oregon Health and Science University
- National Institute on Aging (NIA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1234567
- U19AG071754