Detect brain alpha synuclein deposits
- Trial ID
- NCT06891703
- Official Title
- Phase 1 Study to Evaluate [18F]ACI-15916 as a Potential PET Radioligand for Imaging α-synuclein Deposits in the Brain of Patients With Suspected α-synuclein Pathology Compared With Healthy Volunteers
- Goal
- Detect brain alpha synuclein deposits
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- AC Immune SA
- Study Type
- INTERVENTIONAL
- Enrollment
- 46 participants
- Conditions
- Parkinson's Disease (PD), Multiple System Atrophy (MSA), Dementia With Lewy Bodies (DLB)
- Interventions
- [18F]ACI-15916
Summary For Families
The goal is to find out whether a new PET tracer, [18F]ACI-15916, can detect and map α-synuclein protein deposits in the brain so clinicians can tell synuclein-related conditions like Parkinson's disease, dementia with Lewy bodies, and MSA apart from healthy brains. The approach injects a fluorine-18 labeled molecule that selectively binds α-synuclein aggregates and produces a PET signal to visualize and quantify those deposits; it is a diagnostic imaging agent, not a treatment, and scans are done while symptomatic meds are kept on a stable dose. The trial is looking for healthy adults aged 20 and older and people aged 40 and older with diagnosed or suspected PD, DLB, or MSA who have evidence of dopamine transporter loss on DAT imaging, meet body weight and BMI limits, are not pregnant, and have not received prior α-synuclein,targeting therapies or have excluded genetic forms or major medical issues.
Locations
- Karolinska Institutet, Solna, Sweden
Frequently Asked Questions
- What is this trial testing?
- This trial is studying [18F]ACI-15916. The goal is to find out whether a new PET tracer, [18F]ACI-15916, can detect and map α-synuclein protein deposits in the brain so clinicians can tell synuclein-related conditions like Parkinson's disease, dementia with Lewy bodies, and MSA apart from healthy brains. The approach injects a fluorine-18 labeled molecule that selectively binds α-synuclein aggregates and produces a PET signal to visualize and quantify those deposits; it is a diagnostic imaging agent, not a treatment, and scans are done while symptomatic meds are kept on a stable dose. The trial is looking for healthy adults aged 20 and older and people aged 40 and older with diagnosed or suspected PD, DLB, or MSA who have evidence of dopamine transporter loss on DAT imaging, meet body weight and BMI limits, are not pregnant, and have not received prior α-synuclein,targeting therapies or have excluded genetic forms or major medical issues.
- Who can participate?
- Participants must be at least 20 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 trial is estimated to last approximately 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.