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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 being developed for imaging alpha-synuclein deposits in the brain. It is intended for use in conditions such as alpha-synucleinopathy, Parkinson's disease, dementia with Lewy bodies, and multisystem atrophy. The drug is a PET radioligand, meaning it is designed to bind to alpha-synuclein for diagnostic imaging purposes.
MNI-1216 targets alpha-synuclein deposits in the brain. It is a PET radioligand designed to bind to these deposits, allowing for their visualization through positron emission tomography imaging. This targeting is relevant to neurological conditions characterized by alpha-synuclein accumulation, such as Parkinson's disease and dementia with Lewy bodies.
MNI-1216 is being developed by AC Immune SA, a biopharmaceutical company. The company's stock is traded under the ticker symbol ACIU. AC Immune is conducting clinical research on this investigational PET radioligand for imaging alpha-synuclein deposits in the brain.
MNI-1216 is in early Phase 1 clinical development. A clinical trial with the identifier NCT06445465 has been completed, which evaluated the drug as a potential PET radioligand for imaging alpha-synuclein deposits in the brain. The drug remains investigational and has not been approved by regulatory authorities.
MNI-1216 has one completed clinical trial, identified as NCT06445465. This early Phase 1 study evaluated the drug as a PET radioligand for imaging alpha-synuclein deposits in the brain. The trial enrolled 12 participants in the United States, including healthy volunteers, and was actively controlled but not randomized or double-blinded.
MNI-1216 is not known to be the same as any other drug under a different name. It is an investigational PET radioligand developed by AC Immune SA for imaging alpha-synuclein deposits in the brain. No alternative names have been reported for this compound.