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

April 12, 2011 updated by: The University of Texas Health Science Center, Houston

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

clinical diagnosis of early PD and age/gender matched controls

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Ability of functional MRI to show distinct features for PD
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Mya C Schiess, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 12, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SchiessEPDX2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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