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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716258
Recruitment Status : Suspended (COVID-19 Research Restrictions)
First Posted : October 23, 2018
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
Joseph Quinn, 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterizing Biomarkers of Early Parkinson's Disease Progression
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Peripheral Blood Treg Percentage (1 year) [ Time Frame: 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 :
  1. Peripheral Blood Treg Percentage (6 months) [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Blood separated into buffy coat (for T-cells) and optional banking of plasma in a biorepository


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Early, untreated Parkinson's disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716258


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
VA Portland Health Care System
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Portland VA Medical Center
Investigators
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Principal Investigator: Joseph F Quinn, MD Oregon Health and Science University

Publications of Results:
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Responsible Party: Joseph Quinn, Principle Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03716258    
Other Study ID Numbers: 18545
4277 ( Other Identifier: VHAPORHCS )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joseph Quinn, Oregon Health and Science University:
Parkinson Disease
Biomarkers
Inflammation
Additional relevant MeSH terms:
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Parkinson Disease
Movement Disorders
Disease Progression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes