Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06891703 | [18F]ACI-15916 PET in α-synucleinopathies | EARLY_PHASE1 | RECRUITING | 46 | — | — | Mar 20, 2025 | Mar 1, 2026 | Nov 19, 2025 | 1 | Sweden |
Vital signs measurements will be performed after the PET scan is completed and will be compared with measurements performed before the injection of \[18F\]ACI-15916
\[18F\]ACI-15916 uptake in relevant regions of interest of the brain will be measured with PET scan and the mean of each group (participants with α-synucleinopathies and healthy volunteers) will be calculated
| Arm | Type | Description |
|---|---|---|
| Participants with suspected α-synucleinopathies | EXPERIMENTAL | The study population will be composed of participants with suspected α-synucleinopathies |
| Healthy volunteers | ACTIVE_COMPARATOR | The study population will be composed of healthy volunteers |
| Name | Type | Description |
|---|---|---|
| [18F]ACI-15916 | OTHER | \[18F\]ACI-15916 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of α-synuclein deposits. |
Inclusion Criteria for all Participants: 1. Subject is able to provide written informed consent, which must be obtained before any assessment is performed. 2. Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements. 3. Body mass index is \>...