Spectroscopy in Parkinson Disease (SPIN-PD)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment
Parkinson Disease	Other: Blood draw

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Evaluation of Blood Biospectroscopy as a Novel Diagnostic Test for Idiopathic Parkinson Disease
Study Start Date :	October 2009
Estimated Primary Completion Date :	March 2013
Estimated Study Completion Date :	March 2014

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. 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 ]
2. 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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

1. PostCEPT subjects with a diagnosis of PD based on UK Brain Bank criteria.
2. Willing and able to provide informed consent.

Healthy Controls:

1. No current diagnosis or known history of a neurological disease/disorder.
2. Non-blood relative of a patient or subject at the site who has diagnosis of PD (may include healthy controls from the PROBE study).
3. No first degree relatives with diagnosis of PD
4. MoCA score > 26.
5. Age > 45.
6. Willing and able to provide informed consent.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

The Parkinson Study Group (PSG) is a non-profit, cooperative group of Parkinson's disease experts from medical centers in the United States and Canada who are dedicated to improving treatment for persons affected by Parkinson's disease. 

Publications:

Burns DH, Rosendahl S, Bandilla D, Maes OC, Chertkow HM, Schipper HM. Near-infrared spectroscopy of blood plasma for diagnosis of sporadic Alzheimer's disease. J Alzheimers Dis. 2009;17(2):391-7. doi: 10.3233/JAD-2009-1053.

Schipper HM, Kwok CS, Rosendahl SM, Bandilla D, Maes O, Melmed C, Rabinovitch D, Burns DH. Spectroscopy of human plasma for diagnosis of idiopathic Parkinson's disease. Biomark Med. 2008 Jun;2(3):229-38. doi: 10.2217/17520363.2.3.229.

Responsible Party:	Bruce J. Goldstein / Vice President, Operations, Molecular Biometrics, Inc.
ClinicalTrials.gov Identifier:	NCT01005030 History of Changes
Other Study ID Numbers:	MB_PD001
First Posted:	October 30, 2009
Last Update Posted:	November 10, 2009
Last Verified:	November 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