Blood Biomarker in Early Parkinson's Disease

NCT ID: NCT03384797

Last Updated: 2019-06-10

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

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-22

Study Completion Date

2019-01-07

Brief Summary

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Currently, there are no cures or disease modifying therapies for Parkinson's disease (PD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for PD. Several detection parameters will be assessed through enrollment of Parkinson's patients and age matched healthy volunteers over 50 years of age to learn more about the analytical process and biological variability.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Volunteers

No interventions assigned to this group

Parkinson's Disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Age matched to PD patient Parkinson's Disease Patients:

* 50 years and older
* PD patient who is seen at the Duke Movement Disorders Center
* Early PD diagnosis (Hoehn and Yahr scale ≤ 3)
* Non-smoking
* No cancer treatment in the last 5 years
* Able to read and speak English

Healthy Control Participants:

* 50 years and older
* Non-smoking
* No cancer treatment in the last 5 years
* Able to read and speak English

Exclusion Criteria

Parkinson's Disease Patients:

* Known additional neurological disease
* Clinical trial intervention within the last 6 months

Healthy Control Participants:

* Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's)
* Clinical trial intervention within the last 6 months
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurie Sanders, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Facility

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00088250

Identifier Type: -

Identifier Source: org_study_id

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