RBD Longitudinal as Prognostic for PD

Rapid Eye Movement Sleep Behavior Disorder Clinical Trial

— RBD6YR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00817726
• Other study ID #: HSC-MS-08-0147
• Status: Active, not recruiting
• Start date: January 2009
• Est. completion date: May 2025

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 164
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 35-70 year old men & women

2. (1) Diagnosis of idiopathic RBD (see AASM criteria), 2) Normal control or control with a non-neurodegenerative disorder, age and gender-matched to (1)

3. Gives written informed consent

4. 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.

Related Conditions & MeSH terms

• Mental Disorders
• Rapid Eye Movement Sleep Behavior Disorder
• REM Sleep Behavior Disorder

Locations

Country	Name	City	State
United States	University of texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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