Blood Biomarker in Early Parkinson's Disease

NCT03384797 | Completed

• 1 other identifier: Pro00088250
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

blood; biomarker; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Biological marker of Parkinson's disease

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

  Day 1

Study Arms (2)

Healthy Volunteers

Parkinson's Disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age matched to PD patient Parkinson's Disease Patients:
• 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:
• years and older
• Non-smoking
• No cancer treatment in the last 5 years
• Able to read and speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Facility

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurie Sanders, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 27, 2017
• Study Start: January 22, 2018
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)