Spectroscopy in Parkinson Disease

Parkinson Disease Clinical Trial

— SPIN-PD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01005030
• Other study ID #: MB_PD001
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 29, 2009
• Last updated: November 9, 2009
• Start date: October 2009
• Est. completion date: March 2014

Study information

• Verified date: November 2009
• Source: Molecular Biometrics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 46 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Blood draw
Blood draw, two tubes, used for isolation of cell-free blood plasma

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Molecular Biometrics, Inc.	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Correlate plasma biospectra with dopamine transporter neuroimaging data.		Baseline and annually for two years	No

External Links

•   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.