NCT06445465

Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain

Phase 1 Study to Evaluate [18F]MNI-1216 ([18F]ACI-12589) as a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain of Patients With Suspected Alpha-synuclein Pathology Compared With Healthy Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Invicro · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The overall goal of this protocol is to evaluate \[18F\]MNI-1216 (also known as \[18F\]ACI-12589) as an α-synuclein targeted radiopharmaceutical in 3 parts as follows: * Part 1: first in human (FiH) imaging * Optional Part 2: expansion of FiH imaging * Optional Part 3: retest imaging A total of up to 30 participants may be enrolled and participate in the study. Part 1 of the study will include up to 10 participants (target of up to 5 healthy volunteers and up to 5 participants with idiopathic Parkinson's Disease). There will be an ongoing review of study data in Part 1 to evaluate the characteristics of tracer binding and safety. If the study results are deemed adequate in Part 1, Part 2 and/or Part 3 may be initiated. The decision to initiate Part 3 may also include a review of data from Part 2, if Part 2 is performed and the data are available. If performed, Part 2 will include up to 20 participants, including health volunteers and participants with α-synucleinopathies to acquire additional tracer-related data. If performed, Part 3 will include up to 10 participants from in Part 1 and/or Part 2 (including health volunteers and participants with α-synucleinopathies) to evaluate the reliability of \[18F\]MNI-1216 (\[18F\]ACI-12589) Positron Emission Tomography (PET) imaging.

Detailed description

The overall goal of this protocol is to evaluate \[18F\]MNI-1216 (also known as \[18F\]ACI-12589) as an α-synuclein targeted radiopharmaceutical in 3 parts. The specific objective for Parts 1, 2, and 3 is: • To characterize \[18F\]MNI-1216 (\[18F\]ACI-12589) as a PET radioligand for imaging α-synuclein pathology. The additional specific objectives for Part 1 and Part 2 are: * 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 (including idiopathic PD) compared with corresponding data from healthy volunteer participants. * To evaluate the safety of a single injection of \[18F\]MNI-1216 (\[18F\]ACI-12589). The additional specific objectives for Part 3 are: * To evaluate the reliability (test/retest) of \[18F\]MNI-1216 (\[18F\]ACI-12589) parameters in individuals with α-synucleinopathies and healthy volunteers. * To evaluate the safety of up to 2 injections of \[18F\]MNI-1216 (\[18F\]ACI-12589). For each subject participating in the study, the duration of study participation will be up to 78 days. In Part 1 and Part 2 (if Part 2 is performed), screening assessments will occur within 30 days prior to the Baseline \[18F\]MNI-1216 (\[18F\]ACI-12589) Imaging Visit (Day 1). If determined to be necessary by the study team, subjects may participate in an \[18F\]Florbetapir Imaging Visit up to 6 weeks following Day 1 (will be completed between Day 2 and Day 42). A Safety Phone Call for adverse event assessment will occur 4 days (±2 days) following each imaging visit performed. In Part 3 (if performed), subjects will participate in a Retest \[18F\]MNI-1216 (\[18F\]ACI-12589) Imaging Visit between Day 4 and Day 29 (within 3 days to 4 weeks) following the Baseline \[18F\]MNI-1216 (\[18F\]ACI-12589) Imaging Visit (Day 1). A Safety Phone Call for adverse event assessment will occur 4 days (±2 days) following the retest imaging visit, if performed.

Conditions

• Alpha-Synucleinopathy
• Parkinson's Disease
• Dementia With Lewy Bodies
• Multisystem Atrophy

Interventions

Type	Name	Description
DRUG	[18F]MNI-1216	\[18F\]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.

Timeline

• Start date: 2020-12-24
• Primary completion: 2024-11-26
• Completion: 2024-11-26
• First posted: 2024-06-06
• Last updated: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study