Clinical trial NCT00817453: Early Parkinson's Disease (PD) Cross-Sectional
Official title: Cross-Sectional Cohort Study of Laboratory and Clinical Patterns in Early PD
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinical diagnosis of early PD and age/gender matched controls

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
measure: 2) Characterize the sleep, olfactory,medical and neurologic assessments of early symptomatic PD subjects compared to age- and sex-matched normal controls.
timeFrame: 2 years
Secondary outcomes:
measure: Ability of functional MRI to show distinct features for PD
timeFrame: 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Mya C Schiess, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: 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.
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. doi: 10.1136/jnnp.2006.099754. Epub 2006 Dec 18.
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. doi: 10.1001/archneur.60.8.1043. No abstract available.
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. doi: 10.1016/s1353-8020(99)00051-6.