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PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia | Clinical Trials | Clareo Health

TERMINATEDPHASE1

PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia

PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia: Cognitive Relationships

NCT05462340•Washington University School of Medicine

Summary

The purpose of this research is to use specialized brain imaging techniques, Positron Emission Tomography (PET) scan and Magnetic Resonance Imaging (MRI), to learn more about the brain chemistry, e.g., how neurotransmitters and receptors in the brain function in people with schizophrenia compared to healthy controls.

Detailed Description

Abnormalities in brain chemistry can be responsible for the hallucinations and delusions; thus, by treating these abnormalities, physicians can reduce symptoms of schizophrenia. In this study, investigators aim to examine the characteristics of two investigational radiotracers, \[18F\]AZAN and \[18F\]ASEM, in the brains of people with schizophrenia and healthy controls. Radiotracers are drugs in which one or more atoms are "labeled" with a small amount of radioactivity that allows investigators to see how the drug works in humans using PET and MRI brain imaging techniques.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Between 18-55 years old (inclusive)men and women.
•Black/African-American or non Hispanic White/Caucasian
•Healthy as determined by medical history, physical examination, clinical laboratory test results, vital signs, and ECG within the reference ranges for the population or results within acceptable deviations that are not clinically significant as determined by study physician.
•Have sufficient arterial or venous access, as determined by Interventional neuroradiologist or anesthesiologist.
•Able to sign written informed consent and to comply with the study restrictions.
•No DSM-5diagnosis on axes I, II, III, and no currently active psychiatric diagnoses or substance use disorders as determined by \[SCID\]
•If Tobacco or Nicotine user-willing to abstain from products at least 3 hours prior to all PET scans until completion of the scan.
•Subjects with known chronic SCZ or acute psychotic episodes where suspicion of SCZ is high
•Patients who are drug naïve or nonadherent based on patient report or collateral information OR: a. Subjects on stable (3-months) doses of antipsychotics including risperidone, aripiprazole, ( Part 1 ) Note: if the results of Part 2 ( Aim 4 ) support the null hypothesis for olanzapine effects then investigators will include subjects with schizophrenia on chronic olanzapine. b. Subjects off and then on olanzapine only ( Part 2 )
•3.18-55 years old (inclusive).
+1 more criteria

Exclusion Criteria

•Are currently enrolled in or discontinued within the last 30 days from a clinical trial involving an investigational drug or device (other than the study drug) or are currently enrolled in any other type of medical research.
•Have participated in other research protocols specifically regulated under 21 CFR 361.1 in the last year such that radiation exposure would exceed the annual limits.
•Pregnant or nursing women.
•History of head trauma with prolonged loss of consciousness (\>10 minutes) or any neurological condition including stroke or seizure (excluding childhood febrile seizure) or history of migraine headache.
•Abnormal vital signs, ECG or clinical laboratory evaluations which are considered clinically significant by the clinical investigator.
•Suffer from claustrophobia and would be unable to undergo MRI or PET scanning.
•Clinically significant abnormal MRI.
•Subject has implanted or embedded metal objects, prostheses, or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field.
•Currently uses prescription medications, over-the-counter drugs or herbal remedies such as St. Johns Wort) which cannot be discontinued 14 days (or \<5 half-lives, whichever is longer), prior to the PET scan and throughout the study. Exceptions include daily multiple vitamins.
•Currently a user (including "recreational use") of any illicit drugs or alcohol abuse, or has a positive drug screen.
+18 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

August 18, 2022

Primary Completion Date

January 7, 2025

Completion Date

January 7, 2025

Last Updated

April 3, 2025

Enrollment

117

ACTUAL participants

Conditions

Schizophrenia

Interventions

[18F]ASEM

DRUG

[18F]AZAN

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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