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

Terminated

• Conditions: Movement Disorders; Parkinson Disease

• Registration Number: NCT03716258
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-10-20
• Study First Submitted QC: 2018-10-20
• Study First Posted: 2018-10-23
• Study Start: 2019-01-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States