Early Parkinson's Disease (PD) Cross-Sectional (EPDX)
- To see if cytokine levels and oligomeric alpha-synuclein levels in blood and cerebrospinal fluid could be used as biological markers for Parkinson's disease (PD) onset and progression.
- To characterize and define patterns in the clinical features of sleep, olfactory function and motor function in the early stages of idiopathic (sporadic) Parkinson's disease (PD)and atypical or late Parkinsonian Syndromes.
All subjects, control,early PD diagnosis and atypical or late Parkinsonian Syndromes, will have 1) a medical and neuro history and physical including videotaping of movements, 2) neuropsychological testing, 3) a sleep study, 4) olfactory (sense of smell) testing, 5)blood draw and LP for serum and CSF testing, & 6) functional MRI. All of these procedures are often done in the diagnosis of PD. Any test performed prior to enrollment as part of the clinical evaluation may be used in place of repeating the procedure. Subjects will have 1 set of study visits (up to 3 visits) in order to accomplish a complete set of data.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Cross-Sectional Cohort Study of Laboratory and Clinical Patterns in Early PD|
- 1) Quantify and compare levels of IL-6, 2, 4,10 and IL-1 beta,IFN,TNF alpha, soluble monomeric alpha-synuclein and oligomeric alpha-synuclein in the CSF and serum of the early PD patients compared to age- and sex-matched controls. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 2) Characterize the sleep, olfactory,medical and neurologic assessments of early symptomatic PD subjects compared to age- and sex-matched normal controls. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Ability of functional MRI to show distinct features for PD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Clinically diagnosed Early iPD
Age/gender matched controls without neurodegenerative diagnosis
atypical or late Parkinsonian Syndromes
Includes subjects facing or having undergone DBS, diagnoses of MSA, PSP or other atypical syndromes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817453
|United States, Texas|
|The University of Texas health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mya C Schiess, MD||The University of Texas Health Science Center, Houston|