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?
- 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.