[18F]ACI-15916 for Parkinson's (NCT06891703)
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?
- 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 trial is estimated to last approximately 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.
- How many visits does this trial involve?
- The study includes a screening period of up to 60 days, a PET scan visit with arterial blood sampling and a safety phone call after the scan; total study duration is up to 10 weeks for Parts 1, 2 and 4 and up to 14 weeks for Part 3.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Injection (minimally invasive); MRI scan (non-invasive); Heart tracing (ECG) (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.