Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MNI-815 · 1 trial · 4 indications
The PET imaging outcome measure to evaluate tau burden will be the standardized uptake value (SUV), which will be calculated for the areas of interest by using the established methods for normalizing to subject weight and injected dose.
| Arm | Type | Description |
|---|---|---|
| [18F]MNI-815 (MNI-815) | EXPERIMENTAL | At the \[18F\]MNI-815 PET imaging visit, subjects will be injected with no more than 10mCi of \[18F\]MNI-815 |
| Name | Type | Description |
|---|---|---|
| [18F]MNI-815 (MNI-815) | DRUG | All enrolled subjects will undergo an \[18F\]MNI-815 PET imaging visit. As a part of the screening visit, subjects will undergo \[18F\]florbetaben (FBB) PET imaging to determine if they have significant amyloid deposition. |
Inclusion Criteria: For all subjects: * Written informed consent must be obtained before any assessment is performed. * Female subjects must be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are chi...
Top 20 of 24 competitors
MNI-815 is an investigational small molecule being studied as a potential PET radioligand for imaging tau protein in the brain of patients with tauopathies, including Alzheimer's Disease. It is in Phase 1 clinical development and is not yet approved by the FDA.
MNI-815 targets tau protein in the brain. It is designed to act as a PET radioligand, which means it is intended to bind to tau protein so that it can be visualized using positron emission tomography imaging in patients with tauopathies such as Alzheimer's Disease.
MNI-815 is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. The company is conducting clinical research on this investigational small molecule for potential use in imaging tau protein in the brain.
MNI-815 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One early Phase 1 trial has been completed, and the drug is not currently in any active clinical trials.
MNI-815 has one completed clinical trial, registered as NCT02531360. This early Phase 1 study evaluated [18F]MNI-815 as a potential PET radioligand for imaging tau protein in the brain of patients with tauopathies, including Alzheimer's Disease, Progressive Supranuclear Palsy, Cortical Basal Syndrome, and Frontal Temporal Dementia.
Yes, MNI-815 is the same as [18F]MNI-815. The clinical trial NCT02531360 refers to the drug as [18F]MNI-815, which is the radiolabeled form of MNI-815 used for PET imaging. The [18F] indicates the fluorine-18 isotope used in the radioligand.