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Spectroscopy in Parkinson Disease (SPIN-PD)

This study is enrolling participants by invitation only.
Sponsor:
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
History of Changes
  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:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Correlate plasma biospectra with dopamine transporter neuroimaging data. [ Time Frame: Baseline and annually for two years ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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:
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.  This link exits the ClinicalTrials.gov site

Publications:
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. Biomarkers in Medicine 2(3): 229-238, 2008.

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
Health Authority: United States: Institutional Review Board

Keywords provided by Molecular Biometrics, Inc.:
Parkinson Disease
blood
plasma
 metabolomics
spectroscopy
oxidative stress.

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on March 03, 2015