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Also known as [18F]MNI-1216
MNI-1216 · 1 trial · 4 indications
Volume of distribution (VT) across multiple brain regions will be measured and comparison between participants with α-synucleinopathies and healthy volunteers will be performed to visually and quantitatively assess brain uptake and pharmacokinetics of \[18F\]MNI-1216 (\[18F\]ACI-12589) as a PET imaging marker for α-synuclein pathology in individuals with α-synucleinopathies.
Participants will be monitored to evaluate the safety of a single injection of \[18F\]MNI-1216 (\[18F\]ACI-12589). The following assessments will be performed to monitor participants for adverse reactions: * Clinical laboratory tests. * Vital signs. * Physical findings. * Electrocardiograms
| Arm | Type | Description |
|---|---|---|
| Participants with α-synucleinopathies. | EXPERIMENTAL | The study population will be composed of participants with α-synucleinopathies. |
| Healthy volunteers | ACTIVE_COMPARATOR | The study population will be composed of health volunteers. |
| Name | Type | Description |
|---|---|---|
| [18F]MNI-1216 | DRUG | \[18F\]MNI-1216 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of α-synuclein deposits. |
Inclusion Criteria: * Participants is able to provide written informed consent, which must be obtained before any assessment is performed. * Female participants must not be of childbearing potential, or agree to use contraception and not donate eggs if of childbearing potential. At the discretion o...
MNI-1216 is an investigational small molecule PET radioligand developed by AC Immune SA for imaging alpha-synuclein deposits in the brain. It is being studied in alpha-synucleinopathy, a group of neurological conditions that includes Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy.
MNI-1216 is used as a PET imaging agent to detect alpha-synuclein deposits in the brain. It is being evaluated in alpha-synucleinopathy, including Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy, to help visualize the protein aggregates associated with these conditions.
MNI-1216 is developed by AC Immune SA, a clinical-stage biopharmaceutical company traded on the Nasdaq under the ticker ACIU. The company focuses on neurodegenerative diseases and is advancing MNI-1216 as a potential PET radioligand for alpha-synuclein imaging.
MNI-1216 is in Phase 1 clinical development. It has completed one early Phase 1 trial and is not yet approved by the FDA. The trial was an active-controlled study with 12 participants, and no active trials are currently listed.
MNI-1216 has been studied in one completed clinical trial, NCT06445465, titled "Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain." The early Phase 1 trial enrolled 12 participants in the United States and included healthy volunteers aged 21 and older.
Yes, MNI-1216 is also known as [18F]MNI-1216. The bracketed notation indicates the radioligand is labeled with fluorine-18, a positron-emitting isotope used in PET imaging. Both names refer to the same investigational imaging agent developed by AC Immune SA.