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Spectroscopy in Parkinson Disease (SPIN-PD)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Molecular Biometrics, Inc..
Recruitment status was: Enrolling by invitation
Recruitment status was: Enrolling by invitation
Sponsor:
Molecular Biometrics, Inc.
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by:
Molecular Biometrics, Inc.
ClinicalTrials.gov Identifier:
NCT01005030
First received: October 29, 2009
Last updated: November 9, 2009
Last verified: November 2009
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Purpose
The primary objective of the study is to determine the utility of blood plasma infrared spectroscopy (biospectroscopy) in distinguishing subjects with idiopathic Parkinson's disease from healthy controls.
| Condition | Intervention |
|---|---|
| Parkinson Disease | Other: Blood draw |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of Blood Biospectroscopy as a Novel Diagnostic Test for Idiopathic Parkinson Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
Further study details as provided by Molecular Biometrics, Inc.:
Primary Outcome Measures:
- The primary outcome of the study is the correct classification of cases of PD and controls. This will be quantified as sensitivity and specificity. [ Time Frame: Baseline and annually for two years ]
Secondary Outcome Measures:
- Determine impact of disease stage, age, gender, medications, cognitive scores, other laboratory measures (e.g. alpha-synuclein) and other clinical/demographic variables on plasma biospectra. [ Time Frame: Baseline and annually for two years ]
- Correlate plasma biospectra with dopamine transporter neuroimaging data. [ Time Frame: Baseline and annually for two years ]
Biospecimen Retention: Samples Without DNA
Blood plasma, cell free
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
PostCEPT Subjects
Subjects with current Parkinson Disease Diagnosis currently enrolled in PostCEPT study
|
Other: Blood draw
Blood draw, two tubes, used for isolation of cell-free blood plasma
|
|
Control Subjects
Non-blood relatives of PostCEPT Subjects matched for age and other demographics
|
Other: Blood draw
Blood draw, two tubes, used for isolation of cell-free blood plasma
|
Detailed Description:
Oxidative stress has been implicated as a factor in the pathogenesis of Parkinson's disease (PD). The overall goal of this proposal is to use a novel metabolomics platform, based on near infrared biospectroscopy, to detect oxidatively modified blood plasma constituents. These spectral findings can be used to model the degree of oxidative stress with a modeled "stress index" that may distinguish PD cases from healthy elderly controls.
Eligibility| Ages Eligible for Study: | 46 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Parkinson's subjects: from pool of subjects currently enrolled in PostCEPT study Control subjects: general population
Criteria
Inclusion Criteria:
PD Subjects:
- PostCEPT subjects with a diagnosis of PD based on UK Brain Bank criteria.
- Willing and able to provide informed consent.
Healthy Controls:
- No current diagnosis or known history of a neurological disease/disorder.
- Non-blood relative of a patient or subject at the site who has diagnosis of PD (may include healthy controls from the PROBE study).
- No first degree relatives with diagnosis of PD
- MoCA score > 26.
- Age > 45.
- Willing and able to provide informed consent.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005030
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005030
Locations
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14620 | |
Sponsors and Collaborators
Molecular Biometrics, Inc.
Michael J. Fox Foundation for Parkinson's Research
Investigators
| Principal Investigator: | Bernard Ravina, MD | University of Rochester |
| Principal Investigator: | Anthony E Lang, MD | University of Toronto |
More Information
Additional Information:
Publications:
| Responsible Party: | Bruce J. Goldstein / Vice President, Operations, Molecular Biometrics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01005030 History of Changes |
| Other Study ID Numbers: |
MB_PD001 |
| Study First Received: | October 29, 2009 |
| Last Updated: | November 9, 2009 |
Keywords provided by Molecular Biometrics, Inc.:
|
Parkinson Disease blood plasma |
metabolomics spectroscopy oxidative stress. |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on June 23, 2017