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PET Radioligand for Parkinson's Disease

Phase < 1
Waitlist Available
Led By David Russell, MD
Research Sponsored by Invicro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female participants must not be of childbearing potential, or agree to use contraception and not donate eggs if of childbearing potential
Be older than 18 years old
Must not have
Unsuitable veins for repeated venipuncture
Participant has received an investigational drug within 30 days or five half-lives prior to the baseline assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 78 days
Awards & highlights

Summary

This trial aims to test a new radiopharmaceutical called [18F]MNI-1216 for targeting α-synuclein in the brain. The study will be conducted in 3

Who is the study for?
This trial is for up to 30 people, including healthy volunteers and those with Parkinson's disease or related disorders. Participants will undergo brain imaging using a new PET radioligand called [18F]MNI-1216. The study has three parts: initial human imaging, an optional expansion phase, and an optional retest phase.
What is being tested?
[18F]MNI-1216 (also known as [18F]ACI-12589) is being tested for its ability to target α-synuclein deposits in the brain, which are associated with conditions like Parkinson's disease. The trial includes first-time testing in humans, potential expansion for more data collection, and a reliability check through retesting.
What are the potential side effects?
As this is a first-in-human study of [18F]MNI-1216 ([18F]ACI-12589), specific side effects are not yet known but will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not able to have children, or I agree to use birth control and not donate eggs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My veins are not suitable for frequent needle sticks.
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I haven't taken any experimental drugs in the last 30 days or five half-lives.
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I have been treated for a condition related to α-synuclein.
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I do not have specific symptoms or a known LRRK2 mutation related to α-synucleinopathy.
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I do not have any major health issues that are not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 78 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 78 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with [18F]MNI-1216-related adverse events as assessed by CTCAE
Volume of distribution (VT) of [18F]MNI-1216 across multiple brain regions
Other outcome measures
Average variability across subjects
Intraclass correlation (ICC) of test and retest scans

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Participants with α-synucleinopathies.Experimental Treatment1 Intervention
The study population will be composed of participants with α-synucleinopathies.
Group II: Healthy volunteersActive Control1 Intervention
The study population will be composed of health volunteers.

Find a Location

Who is running the clinical trial?

InvicroLead Sponsor
18 Previous Clinical Trials
444 Total Patients Enrolled
AC Immune SAIndustry Sponsor
6 Previous Clinical Trials
379 Total Patients Enrolled
David Russell, MDPrincipal InvestigatorInvicro
2 Previous Clinical Trials
67 Total Patients Enrolled
~6 spots leftby Sep 2025
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