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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06891716 | [18F]ACI-19626 PET in TDP-43 Proteinopathies | EARLY_PHASE1 | RECRUITING | 45 | — | — | Jan 21, 2025 | Nov 1, 2026 | Mar 24, 2025 | 1 | Netherlands |
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-19626.
\[18F\]ACI-19626 brain uptake in relevant regions of interest of the brain will be measured with PET scan and the mean of each group (participants with TDP-proteinopathies and healthy controls) will be calculated.
The selection of the optimal kinetic model will be done based on the Akaike's information criterion
The radiation dose absorbed by relevant vital organs and the total effective dose will be measured, and the mean of scanned participants will be calculated
| Arm | Type | Description |
|---|---|---|
| Participants with suspected TDP-43 proteinopathies | EXPERIMENTAL | The study population will be composed of participants with suspected TDP-43 proteinopathies |
| Healthy controls | ACTIVE_COMPARATOR | The study population will be composed of healthy controls. |
| Name | Type | Description |
|---|---|---|
| [18F]ACI-19626 | OTHER | \[18F\]ACI-19626 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of TDP-43 deposits. |
Inclusion Criteria for all Participants: * Subject is able to provide written informed consent (IC), which must be obtained before any assessment is performed. * Female subjects must not be of childbearing potential, or if they are of childbearing potential to agree to use reliable contraception me...