Spectroscopy in Parkinson Disease (SPIN-PD)

November 9, 2009 updated by: Molecular Biometrics, Inc.

Evaluation of Blood Biospectroscopy as a Novel Diagnostic Test for Idiopathic Parkinson Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14620
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parkinson's subjects: from pool of subjects currently enrolled in PostCEPT study Control subjects: general population

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and annually for two years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and annually for two years
Correlate plasma biospectra with dopamine transporter neuroimaging data.
Time Frame: Baseline and annually for two years
Baseline and annually for two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molecular Biometrics, Inc.

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Anthony E Lang, MD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ANTICIPATED)

March 1, 2013

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (ESTIMATE)

October 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2009

Last Update Submitted That Met QC Criteria

November 9, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB_PD001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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