Early Parkinson's Disease (PD) Cross-Sectional

Parkinson's Disease Clinical Trial

— EPDX  

Official title:

Cross-Sectional Cohort Study of Laboratory and Clinical Patterns in Early PD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00817453
• Other study ID #: SchiessEPDX2008
• Status: Terminated
• Phase: N/A
• First received: January 5, 2009
• Last updated: April 12, 2011
• Start date: January 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2011
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	The University of Texas health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bick RJ, Poindexter BJ, Kott MM, Liang YA, Dinh K, Kaur B, Bick DL, Doursout MF, Schiess MC. Cytokines disrupt intracellular patterns of Parkinson's disease-associated proteins alpha-synuclein, tau and ubiquitin in cultured glial cells. Brain Res. 2008 Jun 27;1217:203-12. doi: 10.1016/j.brainres.2008.03.081. Epub 2008 Apr 10. — View Citation

Hood AJ, Amador SC, Cain AE, Briand KA, Al-Refai AH, Schiess MC, Sereno AB. Levodopa slows prosaccades and improves antisaccades: an eye movement study in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2007 Jun;78(6):565-70. Epub 2006 Dec 18. — View Citation

Schiess M, Oh I. Serum uric acid and clinical progression in Parkinson disease: potential biomarker for nigrostriatal failure. Arch Neurol. 2008 Jun;65(6):698-9. doi: 10.1001/archneur.65.6.698. — View Citation

Schiess M. Nonsteroidal anti-inflammatory drugs protect against Parkinson neurodegeneration: can an NSAID a day keep Parkinson disease away? Arch Neurol. 2003 Aug;60(8):1043-4. Review. — View Citation

Schiess MC, Zheng H, Soukup VM, Bonnen JG, Nauta HJ. Parkinson's disease subtypes: clinical classification and ventricular cerebrospinal fluid analysis. Parkinsonism Relat Disord. 2000 Apr 1;6(2):69-76. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No
Primary	2) Characterize the sleep, olfactory,medical and neurologic assessments of early symptomatic PD subjects compared to age- and sex-matched normal controls.		2 years	No
Secondary	Ability of functional MRI to show distinct features for PD		2 years	No