NCT00817726

RBD Longitudinal as Prognostic for PD

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rapid Eye Movement Sleep Behavior Disorder

Timeline

• Start date: 2009-01-01
• Primary completion: 2024-12-01
• Completion: 2025-05-01
• First posted: 2009-01-06
• Last updated: 2023-11-29

Locations

1 site across 1 country: United States