• PDtrials - Parkinson's Disease Clinical Trials
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Official Study Title: Cross-Sectional Cohort Study of Laboratory and Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Patterns in Early PD
Sponsor: The University of Texas Health Science Center, Houston
Clinicaltrials.gov ID: NCT00817453
Study ID: SchiessEPDX2008

Summary

In this study all participants, both those acting as controls and those with early Parkinson’s disease (PD) diagnosis, will have:

1) a medical and neuro history and physical,
2) neuropsychological testing,
3) a sleep study,
4) olfactory (sense of smell) testing, 
5) blood draw and LP (lumbar puncture) for serum and CSF (cerebrospinal fluid) testing (LP may be declined),
6) MRI of the brain,
7) video taken of arm  ArmAny of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more. and leg movements, and of the participant's walk.


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. Participants will have one set of study visits (up to three visits) in order to accomplish a complete set of data.

The purpose of this study is to see if cytokine (a certain protein released by cells) levels and alpha-synuclein (a certain protein found in neural tissue) levels in blood and CSF could be used as biological markers for PD onset and progression.  A secondary purpose of this study is to characterize and define patterns in the clinical features of sleep, olfactory function and motor function in the early stages of PD.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Less than one month
• Two visit days in clinic setting and 1-2 recorded nights of sleep

Eligibility

• Minimum Age: 35
• Maximum Age: 80
• Gender(s) Accepted: Either
• Study is enrolling non-PD participants

Inclusion Criteria

• People with early PD, or people without PD or people who have a non-neurodegenerative diagnosis but are otherwise healthy.
• Written informed consent.  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial.
• Pregnant women are not excluded, but will be identified by a pregnancy test.
  

Exclusion Criteria

• Parkinsonian symptoms not due to PD, such as those that are medication induced, toxic substance induced or representative of an atypical parkinsonian syndrome.
• Any unstable or uncontrolled medical or psychiatric condition.
• Renal (kidney) or hepatic (liver) insufficiency, or a history of significant cardiac disease.
• If there is a history or evidence of coagulopathy (drug-induced liver disease), on medications such as Plavix, Aggrenox, heparin, coumadin, or large doses of aspirin.  Must be able to remain off these medications for at least three days, and have stable blood coagulation values prior to any lumbar puncture (LP).
• Significant dementia  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. that would interfere with study procedures or the giving of informed consent for the study.
• Active infections including skin, respiratory or GI (gastrointestinal) infections, and HIV+ (if undergoing an LP).
• Any evidence of a neurodegenerative disorder, for example, Alzheimer's Disease or Huntington's Disease.
  

Enrollment

Expected Enrollment: 100 (US)
Date Enrollment Began: Jan 2009
Date Enrollment Ends:
Last Updated Date: Sep 28 2009
Trial Post Date: Mar 23 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00817453?term=NCT00817453&rank=1

Primary Contacts and Locations

Texas

• Mya C. Schiess, MD — Principal Investigator
  Mya.C.Schiess@uth.tmc.edu
  Phone: (713) 500-7121
  The University of Texas Health Science Center, Houston
  Houston, TX 77030
  USA
  
• Vicki J. Ephron, RN
  Vicki.J.Ephron@uth.tmc.edu
  Phone: (713) 500-7073
  The University of Texas Health Science Center, Houston
  Houston, TX 77030
  USA