Spectroscopy in Parkinson Disease

• Conditions: Parkinson Disease
• Interventions: Other: Blood draw

• Registration Number: NCT01005030
• Lead Sponsor: Molecular Biometrics, Inc.

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.

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-09
• Last Update Posted: 2009-11-10
• Primary Completion: 2013-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PostCEPT Subjects	Blood draw	Subjects with current Parkinson Disease Diagnosis currently enrolled in PostCEPT study
Control Subjects	Blood draw	Non-blood relatives of PostCEPT Subjects matched for age and other demographics

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the correct classification of cases of PD and controls. This will be quantified as sensitivity and specificity.	Baseline and annually for two years

Secondary Outcome Measures

Name	Time	Method
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.	Baseline and annually for two years
Correlate plasma biospectra with dopamine transporter neuroimaging data.	Baseline and annually for two years

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States