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[11C]CPPC Injection for Amyotrophic Lateral Sclerosis

Phase 1

Waitlist Available

Led By Nicholas J Maragakis, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 10 days after scan

Awards & highlights

Study Summary

This trial is testing a new imaging agent to see if it is safe for use in patients with ALS. The agent will be used in PET scans to see if there are any differences in brain activity between patients with ALS and healthy patients.

Eligible Conditions

ALS (Amyotrophic Lateral Sclerosis)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 10 days after scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 10 days after scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 10 days after scan for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety of use of [11C]CPPC in patients with ALS as assessed by a change in complete blood count (CBC) test

Safety of use of [11C]CPPC in patients with ALS as assessed by a change in complete metabolic panel (CMP) test

Safety of use of [11C]CPPC in patients with ALS as assessed by a change in neurological status

+1 more

Secondary outcome measures

Sensitivity of use of [11C]CPPC as assessed by a radiologist

Trial Design

2Treatment groups

Experimental Treatment

Group I: Participants with diagnosis of ALSExperimental Treatment1 Intervention

Participants with a diagnosis of ALS will receive a single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.

Group II: Healthy Participants without a diagnosis of ALSExperimental Treatment1 Intervention

Healthy participants (without a diagnosis of ALS) will receive a single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,263 Previous Clinical Trials

14,823,161 Total Patients Enrolled

10 Trials studying Amyotrophic Lateral Sclerosis

1,868 Patients Enrolled for Amyotrophic Lateral Sclerosis

Precision MolecularUNKNOWN

Nicholas J Maragakis, MDPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

1,049 Total Patients Enrolled

1 Trials studying Amyotrophic Lateral Sclerosis

1,049 Patients Enrolled for Amyotrophic Lateral Sclerosis

Frequently Asked Questions

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

Has [11C]CPPC Injection been ratified by the FDA?

"Our analysts assess that [11C]CPPC Injection's safety rating is a 1, as this is an early Phase 1 trial. So far there is scant evidence of both its efficacy and safety."

Answered by AI

Is enrollment open for this research protocol?

"Affirmative. According to clinical trials .gov, this research project is actively recruiting participants and have been since September 1st 2021. The number of patients sought currently stands at 18 across a single site with the most recent update on July 11th 2022."

Answered by AI

How many participants are accepted into this clinical experiment?

"Yes, the specified clinical trial is actively seeking volunteers. The initial posting was on September 1st 2021 and has been recently updated on July 11th 2022. This study requires 18 participants at a single medical centre."

Answered by AI

Recent research and studies

Proceedings of the National Academy of SciencesJournal

PET Imaging of Microglia by Targeting Macrophage Colony-stimulating Factor 1 Receptor (CSF1R)

Horti, Andrew G., Ravi Naik, Catherine A. Foss, Il Minn, Varia Misheneva, Yong Du, Yuchuan Wang, et al.. 2019. “PET Imaging of Microglia by Targeting Macrophage Colony-stimulating Factor 1 Receptor (CSF1R)”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1812155116.

clinicaltrials.govStudy

Study of [11C]CPPC to Assess the Safety and Tolerability in Patients With ALS

2021. "Study of [11C]CPPC to Assess the Safety and Tolerability in Patients With ALS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04749433.