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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06445465 | Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain | EARLY_PHASE1 | COMPLETED | 12 | — | — | Dec 24, 2020 | Nov 26, 2024 | Feb 19, 2025 | 1 | United States |
Volume of distribution (VT) across multiple brain regions will be measured and comparison between participants with α-synucleinopathies and healthy volunteers will be performed to visually and quantitatively assess brain uptake and pharmacokinetics of \[18F\]MNI-1216 (\[18F\]ACI-12589) as a PET imaging marker for α-synuclein pathology in individuals with α-synucleinopathies.
Participants will be monitored to evaluate the safety of a single injection of \[18F\]MNI-1216 (\[18F\]ACI-12589). The following assessments will be performed to monitor participants for adverse reactions: * Clinical laboratory tests. * Vital signs. * Physical findings. * Electrocardiograms
| Arm | Type | Description |
|---|---|---|
| Participants with α-synucleinopathies. | EXPERIMENTAL | The study population will be composed of participants with α-synucleinopathies. |
| Healthy volunteers | ACTIVE_COMPARATOR | The study population will be composed of health volunteers. |
| Name | Type | Description |
|---|---|---|
| [18F]MNI-1216 | DRUG | \[18F\]MNI-1216 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: * Participants is able to provide written informed consent, which must be obtained before any assessment is performed. * Female participants must not be of childbearing potential, or agree to use contraception and not donate eggs if of childbearing potential. At the discretion o...