SchizophreniaPhase 1NCT05462340
PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia
A Phase 1 study testing [18F]ASEM and [18F]AZAN in people with Schizophrenia, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- [18F]ASEM and [18F]AZAN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2022to 7 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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]
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- 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).
- 4.Male and female subjects meeting DSM-5 diagnostic criteria for a schizophrenia spectrum disorder, verified by SCID-1/P and schizophreniform (<1 year of symptoms5.Black/African-American or non-hispanic White/Caucasian
Who cannot join
- 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.
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- 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.
- Patients undergoing active use of medications that would influence radiotracer binding, including certain 5-HT3 antiemetics, acetylcholine (ACh) receptor agonists (nicotine) or antagonists, and acetylcholinesterase inhibitors.
- History of substance use disorder (DSM-V); or positive alcohol breath test.
- Are currently experiencing neuropsychiatric illness or severe systemic disease based on history and physical exam.
- 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.
- Patients undergoing active use of medications that would influence radiotracer binding, including certain 5-HT3 antiemetics, acetylcholine (ACh) receptor agonists (nicotine) or antagonists, and acetylcholinesterase inhibitors.
- 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.
- Active substance or alcohol use disorder (including "recreational use") of any illicit drugs meeting criteria for current substance use disorder
- Any subject who has a positive Urine Drug Screen test unless in the Investigator's (Principal Investigator or Sub-Investigator) documented opinion, the positive test does not signal a clinical condition that would impact the safety of the subject or interpretation of the trial results.
- Any subject who has an Alcohol Breathalyzer test result deemed positive by the Investigator (Principal Investigator or Sub-Investigator unless in the Investigator's (Principal Investigator or Sub-Investigator) documented opinion, the positive test does not signal a clinical condition that would impact the safety of the subject or interpretation of the trial results.
- Current treatment with clozapine.
- Current treatment with typical antipsychotics, but not haloperidol.
- Current treatment with antiemetic or smoking cessation medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia: Cognitive Relationships
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- [18F]ASEM, [18F]AZAN
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]ASEMDrug
[18F]ASEM demonstrated excellent imaging properties, as was recently confirmed by others. [18F]ASEM is the 1st validated α7 human PET radiotracer to examine α7-nAChR characteristics in the living brain of SCZ patients. Previous α7 studies in the SCZ literature were done using brains harvested post-mortem, and under variable storage conditions. The proposed studies will also determine α4β2-nAChR [18F]AZAN binding characteristics in the same subjects who complete α7-nAChR PET studies with [18F]ASEM, which will be highly significant for understanding these receptors in SCZ.
[18F]AZANDrug
The most widely used PET radioligand for human imaging of α4β2-nAChR is 2-[18F]FA. Because 2-[18F]FA exhibits very slow brain kinetics, the investigators developed [18F]AZAN, a highly α4β2 specific tracer with optimal brain kinetics. Therefore, the proposed studies will utilize [18F]AZAN to determine α4β2-nAChR [18F]AZAN binding characteristics in the same subjects who complete α7-nAChR PET studies with [18F]ASEM, which will be highly significant for understanding these receptors in SCZ.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Visit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line Receives: Drug: [18F]ASEM; Drug: [18F]AZAN |
| Schizophrenia (ari, brex, risp) | Experimental | Visit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line Receives: Drug: [18F]ASEM; Drug: [18F]AZAN |
| Schizophrenia (olanz) | Experimental | Visit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line 2-wk Titration, 3-wk steady state Receives: Drug: [18F]ASEM; Drug: [18F]AZAN |
| Schizophrenia (no med) | Experimental | Visit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line 2-wk Titration, 3-wk steady state Receives: Drug: [18F]ASEM; Drug: [18F]AZAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptor binding of [18F] ASEM-PET to nicotinic brain receptors (α7-nAChRs) in adults ages 18-55 year with SCZ vs. matched controls.
The Primary Outcome Measure is volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) of alpha-7 nicotinic receptors (α7-nAChR) bound to by the [18F]ASEM radio tracer in the brain, comparing VT in people with SCZ with VT in otherwise healthy adults matched for all demographics (smoking status, age, sex, race/genotype, parental education).
Measured: 60-74 days
Receptor binding of [18F]AZAN to α4β2 nicotinic acetylcholine receptors (α4β2-nAChR) in adults ages 18-55 years with SCZ vs. matched controls.
The Primary Outcome Measure is volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) of α4β2 nicotinic acetylcholine receptors (α4β2-nAChR) bound to by the [18F]AZAN radio tracer in the brain, comparing % receptor occupancy in people with SCZ with VT in otherwise healthy adults matched for all demographics (smoking status, age, sex, race/genotype, parental education).
Measured: 60-74 days
Relationship between α7-nAChR receptor binding VT and negative symptoms in adult patients ages 18-55 yrs with SCZ.
The Primary Outcome Measure is the main effect of α7-nAChR receptor volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on negative symptoms as measured by the negative symptom sub-scale of the Positive and Negative Symptoms Scale (PANSS) in SCZ patients.
Measured: 60-74 days
Relationship between α4β2-nAChR receptor binding VT and negative symptoms in adult patients ages 18-55 yrs with schizophrenia (SCZ).
The Primary Outcome Measure is the main effect of α4β2-nAChR volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) and the negative symptom sub-scale score of the Positive and Negative Symptoms Scale (PANSS) in SCZ.
Measured: 60-74 days
Relationship between α7-nAChR receptor binding VT and cognitive symptoms, as measured by the Stroop Color-Word Interference Test in SCZ vs. matched controls.
The Primary Outcome Measure is the comparison of the main effect of receptor volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on the Stroop Color-Word Interference Task score in SCZ vs. matched controls.
Measured: 60-74 days
Relationship between α4β2-nAChR receptor binding VT and cognitive symptoms, as measured by the Stroop Color-Word Interference Task in SCZ vs. matched controls.
The Primary Outcome Measure is comparison of the main effect of volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on the Stroop Color-Word Interference Test score between SCZ patients and matched controls.
Measured: 60-74 days
Relationship between α7-nAChR receptor binding VT and performance on the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls.
The Primary Outcome Measure is comparison of the main effect of volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls.
Measured: 60-74 days
Relationship between α4β2-nAChR receptor binding VT and performance on the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls.
The Primary Outcome Measure is comparison of the main effect of volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on the Spatial Attention Resource Allocation Task (SARAT) score in SCZ vs. matched controls.
Measured: 60-74 days
Relationship between α4β2/α7-nAChR receptor binding VT and cognitive functioning, as measured by the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls.
The Primary Outcome Measure is the comparison of the interaction between α4β2/α7-nAChR volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) and the Spatial Attention Resource Allocation Task (SARAT) score in SCZ vs. matched controls.
Measured: 60-74 days
Relationship between α4β2/α7-nAChR receptor binding VT and cognitive functioning, as measured by the Calibrated Neuropsychological Normative Scale (CNNS) score in SCZ vs. matched controls.
The Primary Outcome Measure is the comparison of the interaction between α4β2/α7-nAChR volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) and the Calibrated Neuropsychological Normative Scale (CNNS) score in SCZ vs. matched controls.
Measured: 60-74 days
Secondary outcomes (2)
Relationship between α4β2/α7-nAChR VT and tobacco use disorder in SCZ patients who are smokers vs. non-smoker SCZ patients treated with olanzapine.
The Primary Outcome Measure is the relationship between α4β2/α7-nAChR (VT, represented as ml of plasma/cm^3 of tissue) and smoking status in SCZ taking olanzapine who smoke tobacco.
Measured: 60-74 days
Relationship between the single nucleotide polymorphism (SNP) CHRNA7 rs3087454 and race in SCZ vs. matched controls.
The Primary Outcome Measure is the correlation between CHRNA7 rs3087454 and and race (non-Hispanic Caucasians and African Americans) in SCZ vs. matched controls.
Measured: 60-74 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start18 Aug 2022
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Why it stopped: Study recruitment milestones were not met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462340
- Sponsor's protocol ID
- 202107052
- Status last verified
- Mar 2025
- First submitted
- 23 Jun 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share according to NIH guidelines
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia: Cognitive Relationships
- ClinicalTrials.gov ID
- NCT05462340
- Acronym / sponsor ID
- 202107052
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study recruitment milestones were not met.
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: [18F]ASEM, Drug: [18F]AZANVisit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line |
| Schizophrenia (ari, brex, risp) | Experimental | Drug: [18F]ASEM, Drug: [18F]AZANVisit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line |
| Schizophrenia (olanz) | Experimental | Drug: [18F]ASEM, Drug: [18F]AZANVisit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line 2-wk Titration, 3-wk steady state |
| Schizophrenia (no med) | Experimental | Drug: [18F]ASEM, Drug: [18F]AZANVisit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line 2-wk Titration, 3-wk steady state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]ASEM[18F]ASEM demonstrated excellent imaging properties, as was recently confirmed by others. [18F]ASEM is the 1st validated α7 human PET radiotracer to examine α7-nAChR characteristics in the living brain of SCZ patients. Previous α7 studies in the SCZ literature were done using brains harvested post-mortem, and under variable storage conditions. The proposed studies will also determine α4β2-nAChR [18F]AZAN binding characteristics in the same subjects who complete α7-nAChR PET studies with [18F]ASEM, which will be highly significant for understanding these receptors in SCZ. | Drug | Healthy Volunteers, Schizophrenia (ari, brex, risp), Schizophrenia (no med), Schizophrenia (olanz) |
| [18F]AZANThe most widely used PET radioligand for human imaging of α4β2-nAChR is 2-[18F]FA. Because 2-[18F]FA exhibits very slow brain kinetics, the investigators developed [18F]AZAN, a highly α4β2 specific tracer with optimal brain kinetics. Therefore, the proposed studies will utilize [18F]AZAN to determine α4β2-nAChR [18F]AZAN binding characteristics in the same subjects who complete α7-nAChR PET studies with [18F]ASEM, which will be highly significant for understanding these receptors in SCZ. | Drug | Healthy Volunteers, Schizophrenia (ari, brex, risp), Schizophrenia (no med), Schizophrenia (olanz) |
Primary outcome
Receptor binding of [18F] ASEM-PET to nicotinic brain receptors (α7-nAChRs) in adults ages 18-55 year with SCZ vs. matched controls.
Time frame: 60-74 days
The Primary Outcome Measure is volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) of alpha-7 nicotinic receptors (α7-nAChR) bound to by the [18F]ASEM radio tracer in the brain, comparing VT in people with SCZ with VT in otherwise healthy adults matched for all demographics (smoking status, age, sex, race/genotype, parental education).
Receptor binding of [18F]AZAN to α4β2 nicotinic acetylcholine receptors (α4β2-nAChR) in adults ages 18-55 years with SCZ vs. matched controls.
Time frame: 60-74 days
The Primary Outcome Measure is volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) of α4β2 nicotinic acetylcholine receptors (α4β2-nAChR) bound to by the [18F]AZAN radio tracer in the brain, comparing % receptor occupancy in people with SCZ with VT in otherwise healthy adults matched for all demographics (smoking status, age, sex, race/genotype, parental education).
Relationship between α7-nAChR receptor binding VT and negative symptoms in adult patients ages 18-55 yrs with SCZ.
Time frame: 60-74 days
The Primary Outcome Measure is the main effect of α7-nAChR receptor volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on negative symptoms as measured by the negative symptom sub-scale of the Positive and Negative Symptoms Scale (PANSS) in SCZ patients.
Relationship between α4β2-nAChR receptor binding VT and negative symptoms in adult patients ages 18-55 yrs with schizophrenia (SCZ).
Time frame: 60-74 days
The Primary Outcome Measure is the main effect of α4β2-nAChR volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) and the negative symptom sub-scale score of the Positive and Negative Symptoms Scale (PANSS) in SCZ.
Relationship between α7-nAChR receptor binding VT and cognitive symptoms, as measured by the Stroop Color-Word Interference Test in SCZ vs. matched controls.
Time frame: 60-74 days
The Primary Outcome Measure is the comparison of the main effect of receptor volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on the Stroop Color-Word Interference Task score in SCZ vs. matched controls.
Relationship between α4β2-nAChR receptor binding VT and cognitive symptoms, as measured by the Stroop Color-Word Interference Task in SCZ vs. matched controls.
Time frame: 60-74 days
The Primary Outcome Measure is comparison of the main effect of volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on the Stroop Color-Word Interference Test score between SCZ patients and matched controls.
Relationship between α7-nAChR receptor binding VT and performance on the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls.
Time frame: 60-74 days
The Primary Outcome Measure is comparison of the main effect of volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls.
Relationship between α4β2-nAChR receptor binding VT and performance on the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls.
Time frame: 60-74 days
The Primary Outcome Measure is comparison of the main effect of volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) on the Spatial Attention Resource Allocation Task (SARAT) score in SCZ vs. matched controls.
Relationship between α4β2/α7-nAChR receptor binding VT and cognitive functioning, as measured by the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls.
Time frame: 60-74 days
The Primary Outcome Measure is the comparison of the interaction between α4β2/α7-nAChR volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) and the Spatial Attention Resource Allocation Task (SARAT) score in SCZ vs. matched controls.
Relationship between α4β2/α7-nAChR receptor binding VT and cognitive functioning, as measured by the Calibrated Neuropsychological Normative Scale (CNNS) score in SCZ vs. matched controls.
Time frame: 60-74 days
The Primary Outcome Measure is the comparison of the interaction between α4β2/α7-nAChR volume of distribution (VT, represented as ml of plasma/cm^3 of tissue) and the Calibrated Neuropsychological Normative Scale (CNNS) score in SCZ vs. matched controls.
2 secondary outcomes
Relationship between α4β2/α7-nAChR VT and tobacco use disorder in SCZ patients who are smokers vs. non-smoker SCZ patients treated with olanzapine.
Time frame: 60-74 days
Relationship between the single nucleotide polymorphism (SNP) CHRNA7 rs3087454 and race in SCZ vs. matched controls.
Time frame: 60-74 days
Results and safety
The study was stopped early (reason given: Study recruitment milestones were not met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Yes. Plan to share according to NIH guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]ASEM and [18F]AZAN in people with Schizophrenia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study recruitment milestones were not met.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receptor binding of [18F] ASEM-PET to nicotinic brain receptors (α7-nAChRs) in adults ages 18-55 year with SCZ vs. matched controls. (time frame: 60-74 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.