Characterizing Biomarkers of Early Parkinson's Disease Progression (TREG)

Sponsor

Oregon Health and Science University (Other)

Overall Status

Terminated

CT.gov ID

NCT03716258

Collaborator

Portland VA Medical Center (U.S. Fed)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to look at a blood marker of inflammation in early untreated Parkinson's disease.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Movement Disorders

Detailed Description

Objectives:

Parkinson's disease is the second most common neurodegenerative condition worldwide, and while both motor and non-motor symptoms can be improved with symptomatic therapies, there are currently no drugs that slow or halt progression of the disease. All previous trials of neuroprotective therapies have failed, in large part due to the lack of objective, sensitive biomarkers of Parkinson's disease progression.

Plan:

The proposed study aims to characterize the rate of change in a peripheral blood marker of inflammation (Treg percentage) and three quantitative motor measures (finger tapping, 9-hole peg test and peak turn velocity) in a cohort of 25 untreated PD patients with motor testing and blood sampling performed at baseline and at 6 months

Methods:

Participants will have three visits to the Portland VA over a 12 month period. Assessments will be made regarding their Parkinson's disease progression (motor ability and gait and balance). At each visit, a VA phlebotomist will draw whole blood. The VA lab will analyze whole blood for metabolic CBC with differential. The research team will hand carry blood samples from the VA phlebotomist to Dr. Quinn's VA lab in BLDG 103 - E143. A plasma sample will be added to the Neurologic Disorders Repository (MIRB # 3129). Peripheral blood mononuclear cells (PBMC) will be isolated from buffy coats using Ficoll-Paque. The PBMC will be frozen and batch analyzed for T lymphocytes using flow cytometry at OHSU.

Study Design

Study Type:

Observational

Actual Enrollment :

16 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Characterizing Biomarkers of Early Parkinson's Disease Progression

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

May 1, 2021

Actual Study Completion Date :

May 1, 2021

Outcome Measures

Primary Outcome Measures

Peripheral Blood Treg Percentage (1 year) [Enrollment and 12 months]
Change in peripheral blood Treg number (expressed as percentage of total helper T cells) over a 12 month time period in PD patients

Secondary Outcome Measures

Peripheral Blood Treg Percentage (6 months) [Enrollment and 6 months]
Change in peripheral blood Treg number (expressed as percentage of total helper T cells) over a 6 month time period in PD patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women between the ages of 40 and 80 years
Diagnosis of idiopathic Parkinson's disease based on the UK PD Brain Bank criteria35
PD diagnosis within 5 years (≤ 5 years)
Hoehn and Yahr severity stage less than or equal to 3 (Mild to moderate bilateral disease; some postural instability; physically independent).36
Remain untreated with levodopa or a dopamine agonist for the duration of the study (up to 7 months, can have treatment with MAO-B inhibitors rasagiline or selegiline)
Able to understand and give informed consent for the study
Able to stand and walk unassisted

Exclusion Criteria:

Current use of dopamine-blocking therapy or significant history of dopamine-blocking therapy (> 1 yr of daily use of the following: typical and atypical antipsychotics except for quetiapine and clozapine, metoclopramide, prochlorperazine, tetrabenazine, reserpine)
Autoimmune disease or current anti-inflammatory or immunomodulatory therapy (aspirin, Tylenol, ibuprofen, naproxen OK)
Other condition already causing gait dysfunction or likely to cause significant change in motor/gait function over 6 month period (i.e. knee or hip replacement within the past 6 months or surgery planned during the study, peripheral neuropathy causing impaired proprioception at big toes)
History of treatment with carbidopa/levodopa, dopamine agonist, or amantadine (can have history of treatment with MAO-B inhibitors rasagiline or selegiline)
Patient anticipates that they will require symptomatic treatment for PD within the next 6 months