Approval Probability
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Also known as [18F]MNI-1020
MNI-1020 · 1 trial · 1 indication
Tracer uptake will be expressed in Standardized Uptake Value Ratio (SUVR). Regions used for tracer uptake quantitation will include cortical regions (frontal cortex, posterior cingulate, lateral temporal cortex, parietal cortex, occipital cortex, mesial temporal cortex, inferior temporal cortex, hippocampus, and anterior cingulate). Subcortical regions (basal ganglia, substantia nigra, choroid plexus) will be used for detection of possible off-target binding. Regions predicted to be free of tau pathology will be used as reference (cerebellum and pons). SUVR will be calculated as SUV target/SUV reference region (e.g., cerebellar gray).
Pharmacokinetics of \[18F\]MNI-1020 will be assessed by using plasma concentration data and compared in participants with probable Alzheimer's disease (AD) and age matched healthy participants.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Within the AD participants, the distribution and binding of \[18F\]florbetapir will be compared to the \[18F\]MNI-1020 binding across multiple regions. This will be done by visual reading of scans, with amyloid signal predicted to be high in frontal cortical regions in participants with probable AD and absent from cortex in healthy participants, while tau signal is predicted to be present in hippocampus and entorhinal cortex in healthy elderly participants, and in medial and lateral temporal cortex in participants with probable AD. Semi-quantitative analysis will also be conducted comparing SUVR of the tracers in these same regions, using cerebellum as reference.
| Arm | Type | Description |
|---|---|---|
| [18F]MNI-1020 | EXPERIMENTAL | Participants will receive a single intravenous bolus injection of \[18F\]MNI-1020 at a dose of not more than 10 millicurie (mCi), with a maximum mass dose of 10 microgram (mcg) and maximum volume of 10 milliliter (mL) at imaging visit. |
| Name | Type | Description |
|---|---|---|
| [18F]MNI-1020 | DRUG | Participants will receive a single intravenous bolus injection of \[18F\]MNI-1020 at a dose of not more than 10 millicurie (mCi), with a maximum mass dose of 10 microgram (mcg) and maximum volume of 10 milliliter (mL) at imaging visit. |
Inclusion Criteria: All Participants * Female participants must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year. Male participants and their partners of...
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MNI-1020 is an investigational small molecule being developed by Johnson & Johnson for Alzheimer disease. It is a positron emission tomography imaging agent designed to evaluate tau protein in the brain. It is also known as [18F]MNI-1020. The compound has been studied in a single early phase clinical trial.
MNI-1020 is used as a PET imaging agent to evaluate tau protein in the brains of people with Alzheimer disease compared with healthy participants. It is not a therapeutic treatment for Alzheimer disease. Its purpose is to help visualize and quantify tau pathology as a diagnostic and research tool.
MNI-1020 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the clinical evaluation of the compound as a tau PET imaging agent for Alzheimer disease research.
MNI-1020 is in Phase 1 development. It has completed one early phase 1 clinical trial and is not approved by the FDA. It remains an investigational imaging agent for Alzheimer disease research.
MNI-1020 has been studied in one completed trial, NCT03239561, titled Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants. The early phase 1 study enrolled 15 participants in the United States, including healthy volunteers, and used an uncontrolled design.
Yes, MNI-1020 and [18F]MNI-1020 refer to the same compound. The bracketed notation reflects the fluorine-18 radiolabel used in this PET imaging agent. Both names describe the same Johnson & Johnson tau imaging candidate studied in Alzheimer disease research.