Early Parkinson's Disease (PD) Cross-Sectional

NCT00817453 | Terminated

• 1 other identifier: SchiessEPDX2008
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose:

1. 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. 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 2) Characterize the sleep, olfactory,medical and neurologic assessments of early symptomatic PD subjects compared to age- and sex-matched normal controls.

  2 years

Secondary Outcomes (1)

• Ability of functional MRI to show distinct features for PD

  2 years

Study Arms (3)

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 Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

clinical diagnosis of early PD and age/gender matched controls

You may qualify if:

• year old men \& women
• Patients with iPD or Parkinsonian syndromes, or controls consisting of healthy subjects, or subjects who have a non-neurodegenerative diagnosis but are otherwise healthy.
• Gives written informed consent
• Pregnant women are not excluded, but will be identified by HCG.

You may not qualify if:

• 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.
• Any unstable or uncontrolled medical or psychiatric condition.
• Renal (creatinine over 1.6) or hepatic insufficiency (LFT three-fold higher than normal range), or a history of significant cardiac disease.
• 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).
• Significant dementia (MMSE\<25/30 or MOCA\<25/30) that would interfere with study procedures or the giving of informed consent for the study .
• Active infections including skin, respiratory or GI infections, and HIV+ (if undergoing an LP).
• Any evidence of a different neurodegenerative disorder, for example, Alzheimer's Disease or Huntington's Disease.
• fMRI will not be performed is screening questionnaire identifies a reason.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (5)

• 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. No abstract available.

  PMID: 18541788 BACKGROUND

• 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.

  PMID: 18501880 BACKGROUND

• 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. doi: 10.1136/jnnp.2006.099754. Epub 2006 Dec 18.

  PMID: 17178817 BACKGROUND

• 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. doi: 10.1001/archneur.60.8.1043. No abstract available.

  PMID: 12925357 BACKGROUND

• 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. doi: 10.1016/s1353-8020(99)00051-6.

  PMID: 10699387 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

CSF and serum

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mya C Schiess, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: January 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 14, 2011

Record last verified: 2011-04

Locations

US (1)