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Parkinson DiseaseTREGNCT03716258

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

An observational study of Parkinson Disease and Movement Disorders, run by Oregon Health and Science University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson Disease, Movement Disorders
How many people
16 participants
Where
2 sitesUnited States
Study dates
1 Jan 2019to 1 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Early, untreated Parkinson's disease

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • VA Portland Health Care System

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Characterizing Biomarkers of Early Parkinson's Disease Progression

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

Read the 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.

Keywords
Parkinson Disease, Biomarkers, Inflammation
Medical subject headings
Parkinson Disease, Movement Disorders, Inflammation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral Blood Treg Percentage (1 year)

    Change in peripheral blood Treg number (expressed as percentage of total helper T cells) over a 12 month time period in PD patients

    Measured: Enrollment and 12 months

Secondary outcomes (1)

  1. Peripheral Blood Treg Percentage (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

    Measured: Enrollment and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2018
  2. Study start1 Jan 2019
  3. Primary completion1 May 2021
  4. Study completion1 May 2021

Why it stopped: COVID-19 Research Restrictions

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03716258
Sponsor's protocol ID
18545
Other IDs
4277
Acronym
TREG
Status last verified
Apr 2022
First submitted
20 Oct 2018
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Monahan AJ, Warren M, Carvey PM. Neuroinflammation and peripheral immune infiltration in Parkinson's disease: an autoimmune hypothesis. Cell Transplant. 2008;17(4):363-72.

    PubMed 18522239

  • Saunders JA, Estes KA, Kosloski LM, Allen HE, Dempsey KM, Torres-Russotto DR, Meza JL, Santamaria PM, Bertoni JM, Murman DL, Ali HH, Standaert DG, Mosley RL, Gendelman HE. CD4+ regulatory and effector/memory T cell subsets profile motor dysfunction in Parkinson's disease. J Neuroimmune Pharmacol. 2012 Dec;7(4):927-38. doi: 10.1007/s11481-012-9402-z. Epub 2012 Oct 11.

    PubMed 23054369

  • Mancini M, Carlson-Kuhta P, Zampieri C, Nutt JG, Chiari L, Horak FB. Postural sway as a marker of progression in Parkinson's disease: a pilot longitudinal study. Gait Posture. 2012 Jul;36(3):471-6. doi: 10.1016/j.gaitpost.2012.04.010. Epub 2012 Jun 29.

    PubMed 22750016

  • Haaxma CA, Bloem BR, Borm GF, Horstink MW. Comparison of a timed motor test battery to the Unified Parkinson's Disease Rating Scale-III in Parkinson's disease. Mov Disord. 2008 Sep 15;23(12):1707-17. doi: 10.1002/mds.22197.

    PubMed 18649395

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Movement Disorders, run by Oregon Health and Science University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: COVID-19 Research Restrictions). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peripheral Blood Treg Percentage (1 year) (time frame: Enrollment and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03716258, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

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