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PET Radiotracer

M1 Receptor PET Imaging for Schizophrenia

Phase 2

Waitlist Available

Led By Rajiv Radhakrishnan, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Men and women aged 18-55 years that are physically and mentally healthy with the exception of DSM-5 schizophrenia or schizoaffective disorder diagnosis

No significant medical history, including head trauma and bleeding disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days

Awards & highlights

Study Summary

This trial is looking into if M1 receptors in the brain could be a target for treating cognitive symptoms in people with schizophrenia, and if so, if those M1 receptors could help with things like memory.

Who is the study for?

This trial is for men and women aged 18-55, either healthy or diagnosed with schizophrenia or schizoaffective disorder according to DSM-5. Participants must not have metal in their body that could interfere with MRI scans, no significant medical history like head trauma, and cannot be smokers unable to abstain for 5 days.Check my eligibility

What is being tested?

The study tests a novel PET radiotracer called 11C-EMO on its ability to highlight M1 receptors in the brain. It aims to link receptor availability with cognitive performance and illness severity in schizophrenia patients through EEGs and memory tests.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from the imaging procedures (PET/MRI scans), allergic reactions to the tracer, or temporary changes in cognition due to testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18-55 years old and healthy, except for having schizophrenia or schizoaffective disorder.

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I don't have a history of serious illnesses, head injuries, or bleeding problems.

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I am between 18 and 55 years old and healthy, except for having schizophrenia or schizoaffective disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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

Hippocampal M1 availability

Secondary outcome measures

evoked ɣ oscillations

verbal memory

Trial Design

1Treatment groups

Experimental Treatment

Group I: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 ReceptorExperimental Treatment1 Intervention

Participants will undergo a single PET scan with [11C]EMO ≤ 20 mCi

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor

2021

Completed Phase 2

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,195 Total Patients Enrolled

59 Trials studying Schizophrenia

4,001 Patients Enrolled for Schizophrenia

National Institute of Mental Health (NIMH)NIH

2,785 Previous Clinical Trials

2,689,738 Total Patients Enrolled

248 Trials studying Schizophrenia

89,406 Patients Enrolled for Schizophrenia

Rajiv Radhakrishnan, MDPrincipal InvestigatorYale University

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

[11C]EMO (PET Radiotracer) Clinical Trial Eligibility Overview. Trial Name: NCT05105542 — Phase 2

Schizophrenia Research Study Groups: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor

Schizophrenia Clinical Trial 2023: [11C]EMO Highlights & Side Effects. Trial Name: NCT05105542 — Phase 2

[11C]EMO (PET Radiotracer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05105542 — Phase 2

Frequently Asked Questions

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

Is the current phase of this trial open for enrollment?

"Clinicaltrials.gov declares that this study is actively seeking patients, with the trial having been initially posted on April 20th 2021 and last updated September 16th 2022."

Answered by AI

Could I potentially join the cohort of participants for this experiment?

"This research project seeks 18 volunteers, aged between 18 and 55 who have been diagnosed with schizophrenia. To qualify for the study, participants must meet additional criteria such as not having any metal in their body which may be an issue during MRI scanning and being mentally and physically healthy besides their diagnosis of DSM-5 schizophrenia or schizoaffective disorder. Furthermore, they should also have no significant history of medical ailments including head trauma or bleeding disorders."

Answered by AI

How many individuals are partaking in this experiment?

"Affirmative, the clinicaltrial.gov website attests that this research study is actively recruiting patients. It was initially posted on April 20th 2021 and has been updated for the final time on September 16th 2022; 18 participants are needed from 1 designated medical centre."

Answered by AI

Has 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor been legally sanctioned by the FDA?

"Our team at Power has assigned 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor a safety rating of 2 due to the fact that clinical trials are only in Phase 2, having shown some promise around its security yet none concerning efficacy."

Answered by AI