Characterizing Biomarkers of Early Parkinson's Disease Progression (TREG)
Stopped early
Conditions studied: Parkinson Disease, Movement Disorders
In brief
The purpose of this study is to look at a blood marker of inflammation in early untreated Parkinson's disease.
Key facts
- Study ID
- NCT03716258
- Run by
- Oregon Health and Science University
- People needed
- 16
- Starts
- 2019-01-01
- Expected to finish
- 2021-05-01
- Last updated by the study team
- 2022-04-20
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States
- VA Portland Health Care System — Portland, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.