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
Plain-Language Summary
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.