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Also known as [18F]MNI-815 (MNI-815)
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...
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MNI-815 is an investigational small molecule PET radioligand developed by Lantheus Holdings, Inc. (LNTH) for imaging tau protein in the brain. It is being studied in Alzheimer's disease and other tauopathies. It is an early-phase research agent, not an approved therapy.
MNI-815 is being evaluated as a PET imaging agent to detect and visualize tau protein deposits in the brains of patients with Alzheimer's disease and related tauopathies. It is intended as a diagnostic imaging tool, not as a treatment for the disease itself.
MNI-815 is developed by Lantheus Holdings, Inc., which trades on the Nasdaq under the ticker LNTH. Lantheus is the sponsor of the clinical program evaluating this PET radioligand.
MNI-815 is in Phase 1 clinical development. It has completed one early-phase trial and is not currently active in any trials. It is an investigational agent and has not been approved by the FDA for any indication.
MNI-815 has been studied in one completed clinical trial, NCT02531360, titled Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Tauopathies. The trial enrolled 7 participants in the United States and included patients with Alzheimer's disease, progressive supranuclear palsy, cortical basal syndrome, and frontotemporal dementia.
Yes, MNI-815 and [18F]MNI-815 refer to the same compound. The bracketed notation indicates the fluorine-18 radioisotope used in the PET imaging agent. Both names appear in the scientific literature and trial records for this Lantheus Holdings radioligand.