18F-OP-801 for Parkinson's (NCT05395624)
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
Summary For Families
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1/Phase 2 trial is estimated to last approximately 2 years and 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Intravenous infusion (minimally invasive); PET scan (minimally invasive). Confirm the full schedule with the study coordinator.