Status:
UNKNOWN
RBD Longitudinal as Prognostic for PD
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Rapid Eye Movement Sleep Behavior Disorder
Eligibility:
All Genders
35-70 years
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 Parkinso...
Detailed Description
Enrollment of PD and PS cohorts is complete. Currently enrolling only confirmed RBD and Controls.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00817726
Start Date
January 1 2009
End Date
May 1 2025
Last Update
November 29 2023
Active Locations (1)
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1
University of texas Health Science Center at Houston
Houston, Texas, United States, 77030