NCT03716258

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2.3 years

First QC Date

October 20, 2018

Last Update Submit

April 18, 2022

Conditions

Parkinson DiseaseMovement Disorders

Keywords

Parkinson DiseaseBiomarkersInflammation

Outcome Measures

Primary Outcomes (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

    Enrollment and 12 months

Secondary Outcomes (1)

  • Peripheral Blood Treg Percentage (6 months)

    Enrollment and 6 months

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Early, untreated Parkinson's disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Related Publications (4)

  • 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.

    PMID: 18522239RESULT

  • 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.

    PMID: 23054369RESULT

  • 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.

    PMID: 22750016RESULT

  • 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.

    PMID: 18649395RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood separated into buffy coat (for T-cells) and optional banking of plasma in a biorepository

MeSH Terms

Conditions

Parkinson DiseaseMovement DisordersInflammation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph F Quinn, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 20, 2018

First Posted

October 23, 2018

Study Start

January 1, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

US(2)