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Brain Imaging Tracer for Neurodegenerative Disease

Q: What is the cumulative number of participants in this research project?

<p>Indeed, the information available on clinicaltrials.gov affirms that this medical study is actively looking for participants. It was originally posted on 8th of January 2021 and its most recent update occurred on 10th of April 2022. Currently they are recruiting 40 subjects from a single site.</p>

Q: Are there still slots available for participants in this experiment?

<p>The clinical trial is still recruiting volunteers, as noted on the official website. It was initially listed on August 1st 2021 and last refreshed just recently on April 10th 2022.</p>

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

Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of the study participation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 hours from injection

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 agree to use effective birth control or abstain from sex during the study.

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I agree to use effective birth control or abstain from sex during the study.

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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.

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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biodistribution of [11C]MPC6827

Estimation of clearance of [11C]MPC6827

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,793 Total Patients Enrolled

Akiva Mintz, MDPrincipal Investigator - Columbia University

Columbia University

Media Library

[11C]MPC6827 Clinical Trial Eligibility Overview. Trial Name: NCT04575727 — Phase < 1

Alzheimer's Disease Research Study Groups: Health Volunteers, Patients with Neurodegenerative Disorders

Alzheimer's Disease Clinical Trial 2023: [11C]MPC6827 Highlights & Side Effects. Trial Name: NCT04575727 — Phase < 1

[11C]MPC6827 2023 Treatment Timeline for Medical Study. Trial Name: NCT04575727 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cumulative number of participants in this research project?

"Indeed, the information available on clinicaltrials.gov affirms that this medical study is actively looking for participants. It was originally posted on 8th of January 2021 and its most recent update occurred on 10th of April 2022. Currently they are recruiting 40 subjects from a single site."

Answered by AI

Are there still slots available for participants in this experiment?

"The clinical trial is still recruiting volunteers, as noted on the official website. It was initially listed on August 1st 2021 and last refreshed just recently on April 10th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exploratory Evaluation of [11C]MPC6827

Akiva Mintz 2021. "Exploratory Evaluation of [11C]MPC6827". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04575727.

All > Alzheimer Disease > Alzheimers Disease