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ACI-19626 · 1 trial · 5 indications
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...
ACI-19626 is an investigational PET imaging agent being studied for use in TDP-43 proteinopathies, including Frontotemporal Dementia (FTD), Amyotrophic Lateral Sclerosis (ALS), Limbic Predominant Age-related TDP-43 Encephalopathy (LATE), and Alzheimer's Disease (AD). It is currently in early Phase 1 clinical development.
ACI-19626 is a PET imaging agent designed to target TDP-43 protein aggregates, which are implicated in several neurodegenerative diseases. It is being investigated for its ability to visualize these aggregates in conditions such as Frontotemporal Dementia (FTD) and Amyotrophic Lateral Sclerosis (ALS).
ACI-19626 is being developed by AC Immune SA, a biopharmaceutical company. The company's stock is traded under the ticker symbol ACIU. AC Immune is conducting clinical research on this investigational PET imaging agent for TDP-43 proteinopathies.
ACI-19626 is in early Phase 1 clinical development. It is an investigational agent and has not been approved by regulatory authorities. A clinical trial is currently recruiting participants to evaluate its use as a PET imaging agent in TDP-43 proteinopathies.
ACI-19626 is being studied in a Phase 1 clinical trial with the identifier NCT06891716, titled "[18F]ACI-19626 PET in TDP-43 Proteinopathies." The trial is recruiting 45 participants in the Netherlands and includes healthy volunteers, as well as individuals with conditions such as Frontotemporal Dementia (FTD) and Amyotrophic Lateral Sclerosis (ALS).