Clinical trial NCT01005030: Spectroscopy in Parkinson Disease
Official title: Evaluation of Blood Biospectroscopy as a Novel Diagnostic Test for Idiopathic Parkinson Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Parkinson Disease
blood
plasma
metabolomics
spectroscopy
oxidative stress.
Lead sponsor: Molecular Biometrics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2009-10-30
Enrollment: 500
Sex: ALL
Minimum age (years): 46
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's subjects: from pool of subjects currently enrolled in PostCEPT study Control subjects: general population

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.

Eligibility 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.

Primary outcomes:
measure: The primary outcome of the study is the correct classification of cases of PD and controls. This will be quantified as sensitivity and specificity.
timeFrame: Baseline and annually for two years
Secondary outcomes:
measure: 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.
timeFrame: Baseline and annually for two years
measure: Correlate plasma biospectra with dopamine transporter neuroimaging data.
timeFrame: Baseline and annually for two years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Bernard Ravina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Anthony E Lang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.