M1 Schizophrenia PET Study

NCT05105542 | Completed Phase 1 FDA Drug

• 3 other identifiers: 20000311711R21MH123870-01A11R01MH113557-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study seeks to examine M1 receptor availability in SZ patients and to relate M1 receptor availability to proximal and distal measures of cognitive performance, namely evoked ɣ oscillations in the EEG and verbal memory. Furthermore, the relationship between hippocampal \[11C\]EMO availability (BPND), evoked ɣ oscillations, verbal memory, and measures of illness severity will be explored.

Conditions

Schizophrenia; Schizoaffective Disorder; Healthy

Keywords

Schizophrenia; Muscarinic M1 Receptor; M1 AChR; [11C]EMO; PET Scan; MRI Scan

Outcome Measures

Primary Outcomes (1)

• Hippocampal M1 availability

  Measured by \[11C\]EMO availability (BPND)

  10 days

Secondary Outcomes (2)

• evoked ɣ oscillations

  10 days

• verbal memory

  10 days

Study Arms (2)

Schizophrenia or schizoaffective disorder

EXPERIMENTAL

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

Drug: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor; Device: PET Scan

Healthy Controls

EXPERIMENTAL

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

Drug: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor; Device: PET Scan

Interventions

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

The radiotracer, \[11C\]EMO, will be administered at the beginning of each PET scan.

Healthy Controls; Schizophrenia or schizoaffective disorder

PET Scan DEVICE

PET scanner with high sensitivity and resolution available for human brain imaging

Healthy Controls; Schizophrenia or schizoaffective disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18- 65 years that are physically and mentally healthy with the exception of DSM-5 schizophrenia or schizoaffective disorder diagnosis
• Subjects with no metal in the body that may pose a risk during MRI scanning
• No significant medical history, including head trauma and bleeding disorders

You may not qualify if:

• Men and women with a history or presence of clinically significant medical conditions
• People who suffer from claustrophobia, have MRI incompatible implants, or other contraindications for MRI and PET scans

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (58)

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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Receptor, Muscarinic M1; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Receptors, Muscarinic; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cholinergic; Receptors, Neurotransmitter; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Rajiv Radhakrishnan, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: Two groups will be studied: 1.) patients diagnosed with schizophrenia or schizoaffective disorder, and 2.) age and gender-matched healthy controls. Both groups will undergo neuroimaging, cognitive assessments, etc.

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: April 20, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)