Blood Biomarker in Early Parkinson's Disease

Blood Biomarker in Early Parkinson's Disease

Sponsors

Lead sponsor: Duke University

Source Duke University
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.

Overall Status Completed
Start Date January 22, 2018
Completion Date January 7, 2019
Primary Completion Date January 7, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Biological marker of Parkinson's disease Day 1
Enrollment 65
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Laurie Sanders, PhD Principal Investigator Duke University
Location
facility Duke University Medical Facility
Location Countries

United States

Verification Date

June 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Healthy Volunteers

Arm group label: Parkinson's Disease

Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov