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Early Parkinson's Disease (PD) Cross-Sectional (EPDX)

This study has been terminated.
(All subjects transferred to long term study NCT00817726 RBD Longitudinal)
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00817453
First received: January 5, 2009
Last updated: April 12, 2011
Last verified: April 2011

January 5, 2009
April 12, 2011
January 2009
February 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00817453 on ClinicalTrials.gov Archive Site
Ability of functional MRI to show distinct features for PD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Early Parkinson's Disease (PD) Cross-Sectional
Cross-Sectional Cohort Study of Laboratory and Clinical Patterns in Early PD

Purpose:

  1. 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.
  2. 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.

Procedures:

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

CSF and serum

Non-Probability Sample

clinical diagnosis of early PD and age/gender matched controls

Parkinson's Disease
Not Provided
  • 1
    Clinically diagnosed Early iPD
  • 2
    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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 35-80 year old men & women
  2. Patients with iPD or Parkinsonian syndromes, or controls consisting of healthy subjects, or subjects who have a non-neurodegenerative diagnosis but are otherwise healthy.
  3. Gives written informed consent
  4. Pregnant women are not excluded, but will be identified by HCG.

Exclusion Criteria:

  1. Parkinsonian symptoms not due to idiopathic (sporadic) PD, such as those that are medication induced, toxic substance induced or representative of an atypical Parkinsonian syndrome will be categorized separately.
  2. Any unstable or uncontrolled medical or psychiatric condition.
  3. Renal (creatinine over 1.6) or hepatic insufficiency (LFT three-fold higher than normal range), or a history of significant cardiac disease.
  4. If there is a history or evidence of coagulopathy, on medications such as Plavix, Aggrenox, heparin, coumadin, or large doses of aspirin, must be able to remain off these medications for at least 3 days, and have stable blood coagulation values prior to any lumbar puncture (LP).
  5. Significant dementia (MMSE<25/30 or MOCA<25/30) that would interfere with study procedures or the giving of informed consent for the study .
  6. Active infections including skin, respiratory or GI infections, and HIV+ (if undergoing an LP).
  7. Any evidence of a different neurodegenerative disorder, for example, Alzheimer's Disease or Huntington's Disease.
  8. fMRI will not be performed is screening questionnaire identifies a reason.
Both
35 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817453
SchiessEPDX2008
No
Mya Schiess, MD, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Mya C Schiess, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP