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

Parkinson's Disease Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dementia With Lewy Bodies
• Lewy Body Disease
• Multiple System Atrophy
• Parkinson Disease
• Parkinson's Disease
• Shy-Drager Syndrome

• NCT number: NCT06445465
• Study type: Interventional
• Source: Invicro
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: December 24, 2020
• Completion date: August 2024