Blood Biomarker in Early Parkinson's Disease

June 7, 2019 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parkinson's patients will be recruited from the Duke Movement Disorders Clinic. Healthy adult volunteers will be recruited from the healthy volunteer registry at DEPRU or caregivers of patients seen at the Duke Movement Disorders Clinic.

Description

Inclusion

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Volunteers
Parkinson's Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological marker of Parkinson's disease
Time Frame: Day 1
Test for biological marker of Parkinson's disease, mtDNA damage
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Laurie Sanders, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2018

Primary Completion (Actual)

January 7, 2019

Study Completion (Actual)

January 7, 2019

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00088250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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