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Clinical Trial 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.


Clinical Trial Description

Enrollment of PD and PS cohorts is complete. Currently enrolling only confirmed RBD and Controls. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00817726
Study type Observational
Source The University of Texas Health Science Center, Houston
Contact
Status Active, not recruiting
Phase
Start date January 2009
Completion date May 2025

See also
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Active, not recruiting NCT04020198 - A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients With Synucleinopathies
Recruiting NCT04886076 - Sleep Profiles in REM Sleep Behavior Disorder