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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
The University of Texas Health Science Center, Houston

Brief Summary:


  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.


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
Parkinson's Disease

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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. 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 ]

Secondary Outcome Measures :
  1. Ability of functional MRI to show distinct features for PD [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
CSF and serum

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
clinical diagnosis of early PD and age/gender matched controls

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00817453

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United States, Texas
The University of Texas health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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Principal Investigator: Mya C Schiess, MD The University of Texas Health Science Center, Houston

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Responsible Party: Mya Schiess, MD, The University of Texas Health Science Center, Houston Identifier: NCT00817453     History of Changes
Other Study ID Numbers: SchiessEPDX2008
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by The University of Texas Health Science Center, Houston:
Parkinson's Disease

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases