Blood Biomarker in Early Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Facility

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Biological marker of Parkinson's disease

Time frame: Day 1

Test for biological marker of Parkinson's disease, mtDNA damage

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Dec 27, 2017
Registry last updated: Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed