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Brain Imaging Tracer for Neurodegenerative Disease

Phase < 1

Recruiting

Led By Akiva Mintz, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have a negative pregnancy test if female of childbearing potential

Negative pregnancy test if female of childbearing potential.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 hours from injection

Awards & highlights

No Placebo-Only Group

Summary

This trial will help assess how a new brain imaging tracer works in humans and how it moves through the brain.

Who is the study for?

This trial is for healthy volunteers and individuals with Alzheimer's or ALS. Participants must be adults, not pregnant if female, and willing to use contraception. Healthy volunteers should have no brain diseases, while those with Alzheimer's or ALS must be under a doctor's care.

What is being tested?

[11C]MPC6827 is being tested in this phase 0 study to see how it spreads through the body and what dose humans can absorb safely. The first part involves five healthy volunteers; the second part compares brain imaging between normal subjects and those with neurodegenerative diseases.

What are the potential side effects?

Since this is an exploratory phase 0 study primarily focused on dosimetry and biodistribution of [11C]MPC6827, specific side effects are not detailed but will be 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 pregnant or have confirmed it with a test.

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I am not pregnant or capable of becoming pregnant.

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I do not have any brain diseases.

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I have been diagnosed with Alzheimer's Disease or ALS and am under a doctor's care.

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I am over 18, can read and understand, and can sign a consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 hours from injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 hours from injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours from injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biodistribution of [11C]MPC6827

Estimation of clearance of [11C]MPC6827

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients with Neurodegenerative DisordersExperimental Treatment1 Intervention

Up to 30 patients with neurodegenerative disorders will receive a microdose (10 µg) of \[11C\]MPC6827 and be imaged dynamically for up to 90 minutes using PET/CT for research purposes.

Group II: Health VolunteersExperimental Treatment1 Intervention

In the first stage, five healthy human subjects will receive a microdose (10 µg) of \[11C\]MPC6827, immediately followed by whole body PET/CT to determine dosimetry and perform an initial safety evaluation of the radiotracer. A dose of 20 mCi \[11C\]MPC6827 will be administered and serial whole body PET scans will be acquired up to 2 hours post injection.

0 / 5Eligibility criteria met