NCT01005030

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 10, 2009

Status Verified

November 1, 2009

Enrollment Period

3.4 years

First QC Date

October 29, 2009

Last Update Submit

November 9, 2009

Conditions

Parkinson Disease

Keywords

Parkinson Diseasebloodplasmametabolomicsspectroscopyoxidative stress.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

PostCEPT Subjects

Subjects with current Parkinson Disease Diagnosis currently enrolled in PostCEPT study

Other: Blood draw

Control Subjects

Non-blood relatives of PostCEPT Subjects matched for age and other demographics

Other: Blood draw

Interventions

Blood drawOTHER

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

Control SubjectsPostCEPT Subjects

Eligibility Criteria

Age46 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • PD Subjects:
  • PostCEPT subjects with a diagnosis of PD based on UK Brain Bank criteria.
  • Willing and able to provide informed consent.
  • Healthy Controls:
  • No current diagnosis or known history of a neurological disease/disorder.
  • Non-blood relative of a patient or subject at the site who has diagnosis of PD (may include healthy controls from the PROBE study).
  • No first degree relatives with diagnosis of PD
  • MoCA score \> 26.
  • Age \> 45.
  • Willing and able to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14620, United States

Location

Related 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.

    PMID: 19363272BACKGROUND

  • 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.

    PMID: 20477412BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma, cell free

MeSH Terms

Conditions

Parkinson Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Bernard Ravina, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

  • Anthony E Lang, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2014

Last Updated

November 10, 2009

Record last verified: 2009-11

Locations

US(1)