RBD Longitudinal as Prognostic for PD (RBD6YR)

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Rapid Eye Movement Sleep Behavior Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT00817726

HSC-MS-08-0147

Details and patient eligibility

About

• 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.

Full description

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

Enrollment: 164 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

164 participants in 2 patient groups

1- RBD

Description:

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

Description:

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.