What side effects are associated with this type of intervention?

Common treatments for schizophrenia primarily involve antipsychotic medications. First-generation antipsychotics, such as haloperidol, are associated with extrapyramidal symptoms (EPS) including akathisia, dystonia, and parkinsonism. Second-generation antipsychotics, like aripiprazole and risperidone, tend to cause fewer EPS but can lead to metabolic side effects such as weight gain, diabetes, and dyslipidemia. Clozapine, used for treatment-resistant cases, has significant side effects including agranulocytosis, seizures, and myocarditis, requiring regular monitoring. These medications can also cause sedation, sexual dysfunction, and cardiovascular issues.

What prior FDA approvals exist?

FDA-approved treatments for schizophrenia primarily include second-generation antipsychotics such as clozapine, risperidone, quetiapine, aripiprazole, and olanzapine. These medications are used to manage symptoms and improve cognitive function. Clozapine is particularly noted for its efficacy in treatment-resistant cases. While the study involving [11C]EMO focuses on M1 receptor availability, current FDA-approved treatments do not specifically target this mechanism but rather work through broader dopaminergic and serotonergic pathways.

What other types of research exist?

Promising novel alternatives to [11C]EMO for assessing M1 receptor availability in schizophrenia patients include newer PET radioligands such as [18F]ASEM, which targets the α7 nicotinic acetylcholine receptor, and [18F]MNI-659, which targets phosphodiesterase 10A (PDE10A). Additionally, advancements in MRI techniques, such as functional MRI (fMRI) and diffusion tensor imaging (DTI), can provide complementary insights into brain structure and function. These tools can help correlate receptor availability with cognitive performance and illness severity, offering a comprehensive approach to treatment and diagnosis in 2024.

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PET Radiotracer

M1 Receptor PET Imaging for Schizophrenia

Phase 1

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

No Placebo-Only Group

Summary

This trial uses a special imaging substance to visualize brain activity in schizophrenia patients. It aims to understand the relationship between brain activity and cognitive problems. The study targets schizophrenia patients because they may have deficits in specific brain functions.

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.

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.

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

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

Primary study objectives

Hippocampal M1 availability

Secondary study objectives

evoked ɣ oscillations

verbal memory

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: Schizophrenia or schizoaffective disorderExperimental Treatment2 Interventions

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

Group II: Healthy ControlsExperimental Treatment2 Interventions

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

PET Scan

2006

Completed Phase 3

~630

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

2021

Completed Phase 1

~20

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for schizophrenia are antipsychotic medications, which primarily work by blocking dopamine D2 receptors to reduce psychotic symptoms such as hallucinations and delusions. Second-generation antipsychotics also target serotonin 5HT2A receptors, which can help alleviate negative symptoms and improve mood. The [11C]EMO trial focuses on M1 receptor availability, which is important because M1 receptors are involved in cognitive functions. Understanding how these receptors are affected by schizophrenia and its treatments could lead to better management of cognitive deficits, which are a significant challenge for patients. This matters for schizophrenia patients as it can improve overall treatment outcomes and quality of life by addressing both psychotic and cognitive symptoms.

Visualizing classification of drugs used in psychotic disorders: A 'subway map' representing mechanisms, established classes and informal categories.The effect of high vs. low dose lurasidone on eye movement biomarkers of prefrontal abilities in treatment-resistant schizophrenia.