North American Prodromal Synucleinopathy Consortium Stage 2

Study Overview
=================
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.

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.

Official Title
-----------------
North American Prodromal Synucleinopathy Consortium Stage 2

Conditions
-----------------
REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Dementia, Dementia With Lewy Bodies, Multiple System Atrophy, REM Sleep Parasomnias

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RBD Group<br>Clinical observation involving annual visits to a study site for up to 5 years. | |
| Control Group<br>Clinical observation involving annual visits to a study site for up to 5 years. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |