Clinical trial NCT00817726: RBD Longitudinal as Prognostic for PD
Official title: A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rapid Eye Movement Sleep Behavior Disorder
Keywords: Rapid Eye Movement Sleep Behavior Disorder
Parkinson's Disease
Parkinsonian Syndromes
Atypical Parkinson's
RBD
PD
fMRI
PSP
MSA
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 164
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with polysomnographically-documented RBD, non-neurodegenerative diagnosis Age and gender matched non-RBD diagnosis, non-neurodegenerative diagnosis idiopathic PD diagnosis atypical PD diagnosis

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify the key cognitive and non-motor characteristics for early PD diagnosis
timeFrame: 5 years
Secondary outcomes:
measure: Further characterize the sleep behavior patterns, olfactory function, and neurologic assessments of subjects longitudinally, over 5 years, within each group of patients.
timeFrame: 5 years
measure: functional MRI of the brain and eye tracking testing, identification of distinct features in PD
timeFrame: beginning of study and at 2 years
measure: identify key fluid-based PD-associated molecular markers that identify disease state or progression
timeFrame: 5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University fo texas Health Science Center at Houston
name: Mya C Schiess, MD
role: PRINCIPAL_INVESTIGATOR
References: