Early Parkinson's Disease (PD) Cross-Sectional (EPDX)
|ClinicalTrials.gov Identifier: NCT00817453|
Recruitment Status : Terminated (All subjects transferred to long term study NCT00817726 RBD Longitudinal)
First Posted : January 6, 2009
Last Update Posted : April 14, 2011
- 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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Cross-Sectional Cohort Study of Laboratory and Clinical Patterns in Early PD|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
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.
- 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 ]
- 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 ]
- Ability of functional MRI to show distinct features for PD [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|