Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IBVM and SPECT imaging · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 2 cohorts | EXPERIMENTAL | In this observational study 2 cohorts will participate. Cohort 1 will include people with Parkinson disease and Cohort 2 will include healthy volunteers. A subset of twelve subjects (8 PD and 4 HC) will be enrolled in the \[123I\] IBVM and SPECT imaging portion of this study |
| Name | Type | Description |
|---|---|---|
| [123I] IBVM and SPECT imaging | DRUG | Subjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging. |
| Subjects will undergo the 123-I IBVM imaging visit | DRUG | Subjects will be injected with a bolus of up to 4 mCi of 123-I IBVM followed by serial SPECT imaging. |
Inclusion and Exclusion Criteria PD subjects Inclusion criteria: * The participant is 30 years or older. * Written informed consent is obtained. * Participants have a clinical diagnosis of Parkinson's disease based on Brain Bank Criteria. * Mini-mental status examination (MMSE) score ≥24 or signi...
IBVM and SPECT imaging is an investigational small molecule being studied for use in Parkinson Disease. It is a biomarker-selected approach in early Phase 1 clinical development. The agent is intended for use in imaging, though its precise role in Parkinson Disease management remains under investigation.
IBVM and SPECT imaging is being developed by United Therapeutics Corporation, traded on the NASDAQ under the ticker UTHR. The company is conducting clinical research on this investigational small molecule for Parkinson Disease.
IBVM and SPECT imaging is in Phase 1 clinical development, specifically early Phase 1. It is an investigational agent and has not been approved by regulatory authorities. One early-phase trial has been completed, and the agent remains in clinical development.
IBVM and SPECT imaging was studied in clinical trial NCT00556764, titled 'Development of Cognitive Assessment Tools in Parkinson Disease.' This early Phase 1 trial enrolled 75 participants in the United States and has been completed. The trial included healthy volunteers and was not randomized or blinded.
IBVM and SPECT imaging is the name used in clinical development for this investigational agent. No alternative names have been established in the available clinical trial information. The agent is being studied specifically for its imaging properties in Parkinson Disease.