Delay need for symptom medication
- Trial ID
- NCT06757010
- Official Title
- A Double-Blind, Randomized, Placebo-controlled, Study of NE3107 in Subjects With Early Parkinson's Disease
- Goal
- Delay need for symptom medication
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- BioVie Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinsons Disease (PD)
- Interventions
- NE3107, Placebo
Plain-Language Summary
The goal is to see whether reducing neuroinflammation and insulin resistance can slow early Parkinson's progression or delay the need for dopaminergic symptom treatments. NE3107 is an oral small molecule that dampens inflammatory signaling and improves insulin signaling by modulating pathways such as ERK and NF-kB, it is not a dopamine replacement and would not directly relieve motor symptoms like levodopa. The trial seeks people 45 to 80 years old diagnosed with idiopathic Parkinson's within the past 18 months who are nearing the need for symptomatic therapy but have not yet taken levodopa or similar drugs, and who are willing to give consent and blood samples including for DNA methylation.
Locations
- Quest Research Institute, Farmington Hills, Michigan, United States
- Dent Neurologic, Amherst, New York, United States
- Science 37 (Nationwide Site), Morrisville, North Carolina, United States
- NeuroScience Research Center, LLC, Canton, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying NE3107. The goal is to see whether reducing neuroinflammation and insulin resistance can slow early Parkinson's progression or delay the need for dopaminergic symptom treatments. NE3107 is an oral small molecule that dampens inflammatory signaling and improves insulin signaling by modulating pathways such as ERK and NF-kB, it is not a dopamine replacement and would not directly relieve motor symptoms like levodopa. The trial seeks people 45 to 80 years old diagnosed with idiopathic Parkinson's within the past 18 months who are nearing the need for symptomatic therapy but have not yet taken levodopa or similar drugs, and who are willing to give consent and blood samples including for DNA methylation.
- Who can participate?
- Participants must be between 45 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 4 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 8 months.