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NCT06445465 · ClinicalTrials.gov registry record · Early Phase 1
Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain
A Early Phase 1 study, sponsored by Invicro.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT06445465: Completed Early Phase 1 study, sponsored by Invicro.
NCT06445465 is a Early Phase 1 study that has completed, run by Invicro. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06445465, a Early Phase 1 study, has completed, sponsored by Invicro.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG [18F]MNI-1216
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-12-24 |
| Est. Completion | 2024-11-26 |
| Phase | Early Phase 1 |
What the finished NCT06445465 record still lists
NCT06445465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F]MNI-1216 is the first listed.
NCT06445465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06445465 about?
NCT06445465 is a clinical study titled "Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain". 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...
What is the current status of trial NCT06445465?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2020-12-24. Estimated completion is 2024-11-26.
What interventions are being tested in trial NCT06445465?
The interventions under investigation include: [18F]MNI-1216 (DRUG).
Who is sponsoring clinical trial NCT06445465?
This trial is sponsored by Invicro, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06445465's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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