Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for Alzheimer Disease. It is currently in Phase 1 clinical development. The drug is being studied to evaluate tau protein in the brain of participants with Alzheimer's Disease compared to healthy participants.
MNI-1020 is being studied for its effects on tau protein in the brain. A completed early Phase 1 trial evaluated tau protein in participants with Alzheimer's Disease compared to healthy participants, indicating that tau is the molecular target of interest for this investigational small molecule.
MNI-1020 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical research on this investigational small molecule for Alzheimer Disease, with one completed early Phase 1 trial.
MNI-1020 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for Alzheimer Disease. One early Phase 1 trial has been completed, and the drug remains in early-stage clinical development.
MNI-1020 has one completed clinical trial, NCT03239561, titled "Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants." This early Phase 1 study enrolled 15 participants in the United States and included healthy volunteers.
MNI-1020 is not known to have any alternative names. It is an investigational small molecule being developed by Johnson & Johnson for Alzheimer Disease, and no other names for this drug have been identified.