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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 is a Early Phase 1 study that has completed, run by Invicro. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06445465
The ClinicalTrials.gov registry entry for NCT06445465 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Invicro, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [18F]MNI-1216 is the first listed.
NCT06445465 reports 0 study locations.
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.
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