Blood Biomarker in Early Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Blood Biomarker in Early Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384797
• Other study ID #: Pro00088250
• Status: Completed
• Start date: January 22, 2018
• Est. completion date: January 7, 2019

Study information

• Verified date: June 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
United States	Duke University Medical Facility	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological marker of Parkinson's disease	Test for biological marker of Parkinson's disease, mtDNA damage	Day 1