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Diagnostic and Prognostic Biomarkers in Parkinson Disease

NCT ID: NCT00653783

Last Updated: 2008-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Brief Summary

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The overall goal of PROBE is to evaluate the feasibility and potential utility of three markers (alpha-synuclein, transcriptomic profiles and olfactory function) to determine the risk or prognosis of PD.

Detailed Description

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PROBE will test three biomarkers in PD subjects and controls to determine their feasibility and potential utility as markers of risk and prognosis for PD. This is a case control study, in which PD subjects will be compared to neurologically healthy controls and disease controls (MSA and PSP). The blood biomarker samples will be drawn once to evaluate blood alpha-synuclein levels as well as collection of lymphocyte mass for array analysis. Olfaction will be measured using the UPSIT for all subjects. The UPSIT will be conducted as part of PostCEPT for PD subjects and will only be repeated in this study for PD subjects in not done within 6 months. Control subjects may also choose to submit a blood specimen for processing and storage at the Coriell Institute for Medical Research, a research resource supported by the NINDS Human Genetics Resource Center.

Follow-up of the PD population over a 3-year period will allow us to evaluate the prognosis for important motor aspects of PD that will occur frequently in this cohort. These complications of PD include motor complications, postural instability, and non-motor impairment such as cognitive decline.

Healthy and disease control subjects may give permission at the Baseline visit to be contacted and followed in the previously established PSG FOUND study using mail and telephone contact to assess clinical status. Participation in the FOUND study provides another mechanism to maintain contact with subjects and collect supplemental data beyond that collected at the PROBE Baseline visit.

Conditions

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Parkinson Disease Multiple System Atrophy Progressive Supranuclear Palsy

Keywords

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Parkinson disease Multiple System Atrophy MSA Progressive Supranuclear Palsy PSP observational biomarker

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subject is participating in PostCEPT and meets UK brain bank criteria for PD
* Willing and able to provide informed consent


* Spouse or non blood relative of the PD subject
* No known current diagnosis or history of a neurological disease
* MMSE score \>27
* Age \>45
* Willing and able to provide informed consent


* A diagnosis of Probable MSA based on Consensus Criteria OR Probable PSP based on NINDS-PSP Criteria
* Willing and able to provide informed consent

Exclusion Criteria

* Current use (within 7 days prior to Baseline Visit) of anticoagulants (e.g., warfarin or heparin)
* Known bleeding disorder (acquired or inherited)
* Known blood disorder (e.g. leukemia) or a history of anemia with a documented hematocrit \<30
* Known pregnancy
* History of nasal trauma, sinusitis, or other nasal pathology that would interfere with smell testing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

The Parkinson Study Group

NETWORK

Sponsor Role lead

Responsible Party

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University of Rochester, Clinical Trials Coordination Center

Principal Investigators

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Bernard Ravina, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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Parkinson Study Group

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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DOD Grant # W81XWH-07-1-0007

Identifier Type: -

Identifier Source: secondary_id

NINDS Grant 5 U01 NS050095-02

Identifier Type: -

Identifier Source: secondary_id

U01NS050095-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01NS050095-02_PROBE

Identifier Type: -

Identifier Source: org_study_id