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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
History of Changes
  Purpose

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.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cross-Sectional Cohort Study of Laboratory and Clinical Patterns in Early PD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Ability of functional MRI to show distinct features for PD [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

CSF and serum


Estimated Enrollment: 150
Study Start Date: January 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

clinical diagnosis of early PD and age/gender matched controls

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817453

Locations
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
Investigators
Principal Investigator: Mya C Schiess, MD The University of Texas Health Science Center, Houston
  More Information

Publications:

Responsible Party: Mya Schiess, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00817453     History of Changes
Other Study ID Numbers: SchiessEPDX2008
Study First Received: January 5, 2009
Last Updated: April 12, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013