RBD Longitudinal as Prognostic for PD

Study Overview
=================
Brief Summary
-----------------
Purpose - to validate a combination of biological and clinical markers in the rapid-eye-movement (REM) sleep behavior disorder (RBD) population as indicative of the pre-symptomatic stage of Parkinson's disease (PD). Procedures - All subjects (RBD diagnosis and controls) will have 1) a medical and neuro history and physical including videotape of movements, 2) neuropsychological testing, 3) a sleep study, 4) olfactory testing, 5) blood draw for serum testing , 6) functional MRI. All of these procedures are often performed clinically in the diagnosis of PD. Enrollment of subjects with PD is complete. Any testing performed prior to enrollment as part of the clinical evaluation may be used in place of repeating the procedure for the study. Subjects will be followed for 5 years. It is hypothesized that a 5 year follow up may capture a significant number of pre-Parkinson's subjects who will be diagnosed. Subjects may be offered a repeat enrollment after 5 years.

Detailed Description
-----------------
Enrollment of PD and PS cohorts is complete. Currently enrolling only confirmed RBD and Controls.

Official Title
-----------------
A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease

Conditions
-----------------
Rapid Eye Movement Sleep Behavior Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35-70 year old men & women (1) Diagnosis of idiopathic RBD (see AASM criteria), 2) Normal control or control with a non-neurodegenerative disorder, age and gender-matched to (1) Gives written informed consent Pregnant women are not excluded, but will be identified by HCG. Exclusion Criteria: a A diagnosis of any non-Parkinsonian Neurodegenerative Disease. b. Any unstable or uncontrolled medical or psychiatric condition. c. Parasomnia or RBD not idiopathic, eg., secondary to metabolic derangement or medicine effect. d. Renal (creatinine over 1.6) or hepatic insufficiency (LFT significantly out of range), or a history of significant uncontrolled cardiac disease. e. Significant dementia (MMSE<25 of 30 or MOCA<25/30) that would interfere with study procedures or informed consent. f. Any reason which, in the opinion of the PI, would increase the risk or decrease the value of any study procedure. g. fMRI will not be performed for anyone for whom the screening questionnaire indicates is ineligible for MRI imaging.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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 |
| --- | --- |
| 1- RBD<br>polysomnographically diagnosed RBD patients. RBD is a sleep disorder diagnosed by a sleep lab in which the individual has muscle movements during the phase of deep sleep during which the muscles should be relaxed. Suspicion of RBD by history will be confirmed during screening. | |
| 2 - control<br>control: must not have any neurological degenerative diagnosis. must NOT have RBD. must be able to age and/or gender-match to RBD and PD subjects already enrolled. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the key cognitive and non-motor characteristics for early PD diagnosis | periodically performed set of clinical and imaging parameters suspected to be linked to PD to see if, as a group, these parameters could identify those at risk for motor symptoms of PD before these symptoms develop. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further characterize the sleep behavior patterns, olfactory function, and neurologic assessments of subjects longitudinally, over 5 years, within each group of patients. | perform baseline sleep study, olfactory testing and clinical neurologic exam followed by periodically performed set of clinical parameters. | 5 years | 
| functional MRI of the brain and eye tracking testing, identification of distinct features in PD | Perform fMRI at baseline and at 2 years followed by periodically performed set of clinical parameters. | beginning of study and at 2 years | 
| identify key fluid-based PD-associated molecular markers that identify disease state or progression | parameters within blood may be present & measurable well before motor symptoms of PD are seen. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PD, Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease, Parkinsonian Syndromes, Atypical Parkinson's, RBD, fMRI, PSP, MSA