Brain scan detects immune activity
- Trial ID
- NCT05395624
- Official Title
- A Phase 1/2 Study to Evaluate Safety, PK and Biodistribution of an Imaging Agent, 18F-OP-801, After Intravenous Administration to Patients With ALS, Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease and Healthy Volunteers
- Goal
- Brain scan detects immune activity
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- Ashvattha Therapeutics, Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 65 participants
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Parkinson Disease (PD), Alzheimer Disease (AD), Multiple Sclerosis (MS)
- Interventions
- 18F-OP-801
Plain-Language Summary
The goal is to evaluate safety, pharmacokinetics, and where 18F-OP-801 goes in the body and brain, and to see whether it reliably highlights immune activity or neuroinflammation in people with Parkinson's. The approach is a single intravenous dose of a fluorine-18 labeled PET tracer, designed to be taken up by immune cells involved in neuroinflammation, followed by PET/CT or PET/MRI to map its biodistribution; it is a diagnostic imaging agent, not a treatment, and does not replace or change levodopa. The study is looking for adults 55 to 80 with definite idiopathic Parkinson's disease per UK Brain Bank criteria who can lie still for scans, have adequate kidney function, are not pregnant, and do not have atypical/secondary parkinsonism or MRI-incompatible implants.
Locations
- UCSF, San Francisco, California, United States
- Stanford University, Stanford, California, United States
- Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying 18F-OP-801. The goal is to evaluate safety, pharmacokinetics, and where 18F-OP-801 goes in the body and brain, and to see whether it reliably highlights immune activity or neuroinflammation in people with Parkinson's. The approach is a single intravenous dose of a fluorine-18 labeled PET tracer, designed to be taken up by immune cells involved in neuroinflammation, followed by PET/CT or PET/MRI to map its biodistribution; it is a diagnostic imaging agent, not a treatment, and does not replace or change levodopa. The study is looking for adults 55 to 80 with definite idiopathic Parkinson's disease per UK Brain Bank criteria who can lie still for scans, have adequate kidney function, are not pregnant, and do not have atypical/secondary parkinsonism or MRI-incompatible implants.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 3 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 1/Phase 2 trial is estimated to last approximately 2 years and 11 months.