Antibody infusion slows symptom progression
- Trial ID
- NCT06773962
- Official Title
- A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of TB006 in Participants With Parkinson's Disease
- Goal
- Antibody infusion slows symptom progression
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- TrueBinding, Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 62 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- TB006, Placebo
Plain-Language Summary
The goal is to test whether TB006 can reduce the brain inflammation and abnormal alpha-synuclein clumping that may drive early Parkinson's, with the hope of slowing symptom progression and confirming safety. TB006 is a monoclonal antibody given by infusion that blocks galectin-3, a protein involved in microglial-driven inflammation and protein aggregation, and it is added on top of standard immediate-release levodopa rather than replacing levodopa; the trial will watch for any safety or interaction effects. The trial is looking for people aged 50 to 80 with early-stage PD diagnosed within the last 5 years, who have mild motor symptoms in the OFF state and are taking immediate-release levodopa-carbidopa or benserazide, and who do not have severe psychiatric illness, recent investigational antibody use, or other medical issues that raise safety concerns.
Locations
- Parkinson's Research Centers of America - Orange County, Aliso Viejo, California, United States
- Parkinson's Research Centers of America - Palo Alto, Palo Alto, California, United States
- CenExel Rocky Mountain Clinical Research, Englewood, Colorado, United States
- Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, United States
- University of Miami, Miami, Florida, United States
- University of South Florida Parkinson's and Movement Disorders Center, Tampa, Florida, United States
- Consultants in Neurology, Ltd, Northbrook, Illinois, United States
- Josephson Wallack Munshower Neurology - Southeast, Indianapolis, Indiana, United States
- University of Kansas Medical Center, Kansas City, Kansas, United States
- Quest Research Institute, Farmington Hills, Michigan, United States
- Parkinson's Research Centers of America - Long Island, Commack, New York, United States
- NYU Langone Health, Patchogue, New York, United States
- Oregon Health & Science University, Portland, Oregon, United States
- Central Texas Neurology Consultants, Round Rock, Texas, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying TB006. The goal is to test whether TB006 can reduce the brain inflammation and abnormal alpha-synuclein clumping that may drive early Parkinson's, with the hope of slowing symptom progression and confirming safety. TB006 is a monoclonal antibody given by infusion that blocks galectin-3, a protein involved in microglial-driven inflammation and protein aggregation, and it is added on top of standard immediate-release levodopa rather than replacing levodopa; the trial will watch for any safety or interaction effects. The trial is looking for people aged 50 to 80 with early-stage PD diagnosed within the last 5 years, who have mild motor symptoms in the OFF state and are taking immediate-release levodopa-carbidopa or benserazide, and who do not have severe psychiatric illness, recent investigational antibody use, or other medical issues that raise safety concerns.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 14 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 11 months.