Parkinson's DiseaseEPDXNCT00817453
Early Parkinson's Disease (PD) Cross-Sectional
An observational study of Parkinson's Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: clinical diagnosis of early PD and age/gender matched controls
Who may be able to join
- 35-80 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Cross-Sectional Cohort Study of Laboratory and Clinical Patterns in Early PD
Purpose:
- 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.
- 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.
Read more
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.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
2) Characterize the sleep, olfactory,medical and neurologic assessments of early symptomatic PD subjects compared to age- and sex-matched normal controls.
Measured: 2 years
Secondary outcomes (1)
Ability of functional MRI to show distinct features for PD
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: All subjects transferred to long term study NCT00817726 RBD Longitudinal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Mya C Schiess, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817453
- Sponsor's protocol ID
- SchiessEPDX2008
- Acronym
- EPDX
- Status last verified
- Apr 2011
- First submitted
- 5 Jan 2009
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18541788Bick 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.
PubMed 18501880Hood 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.
PubMed 17178817Schiess 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.
PubMed 12925357Schiess 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.
PubMed 10699387
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Cohort Study of Laboratory and Clinical Patterns in Early PD
- ClinicalTrials.gov ID
- NCT00817453
- Acronym / sponsor ID
- EPDX / SchiessEPDX2008
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: All subjects transferred to long term study NCT00817726 RBD Longitudinal
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- clinical diagnosis of early PD and age/gender matched controls
Key inclusion criteria (4 listed)
- 35-80 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.
Key exclusion criteria (8 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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) 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
1 secondary outcome
Ability of functional MRI to show distinct features for PD
Time frame: 2 years
Results and safety
The study was stopped early (reason given: All subjects transferred to long term study NCT00817726 RBD Longitudinal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
- Background: PubMed 18541788Schiess 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.
- Background: PubMed 18501880Bick 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.
- Background: PubMed 17178817Hood 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.
- Background: PubMed 12925357Schiess 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.
- Background: PubMed 10699387Schiess 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mya C Schiess, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: All subjects transferred to long term study NCT00817726 RBD Longitudinal). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00817453, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2011.