PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia
NCT05462340, Phase 1, Terminated, Washington University School of Medicine
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | PET Imaging Study of α7 and α4β2-nAChR in Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT05462340 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 117 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Washington University School of Medicine | ClinicalTrials.gov |
| Conditions | Schizophrenia | ClinicalTrials.gov |
| Interventions | [18F]ASEM, [18F]AZAN | ClinicalTrials.gov |
| First posted | 2022-07-18 | ClinicalTrials.gov |
| Last updated | 2025-04-03 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Receptor binding of [18F] ASEM-PET to nicotinic brain receptors (α7-nAChRs) in adults ages 18-55 year with SCZ vs. matched controls. | 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). | ClinicalTrials.gov |
| Primary | Receptor binding of [18F]AZAN to α4β2 nicotinic acetylcholine receptors (α4β2-nAChR) in adults ages 18-55 years with SCZ vs. matched controls. | 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). | ClinicalTrials.gov |
| Primary | Relationship between α7-nAChR receptor binding VT and negative symptoms in adult patients ages 18-55 yrs with SCZ. | 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. | ClinicalTrials.gov |
| Primary | Relationship between α4β2-nAChR receptor binding VT and negative symptoms in adult patients ages 18-55 yrs with schizophrenia (SCZ). | 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. | ClinicalTrials.gov |
| Primary | Relationship between α7-nAChR receptor binding VT and cognitive symptoms, as measured by the Stroop Color-Word Interference Test in SCZ vs. matched controls. | 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. | ClinicalTrials.gov |
| Primary | Relationship between α4β2-nAChR receptor binding VT and cognitive symptoms, as measured by the Stroop Color-Word Interference Task in SCZ vs. matched controls. | 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. | ClinicalTrials.gov |
| Primary | Relationship between α7-nAChR receptor binding VT and performance on the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls. | 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. | ClinicalTrials.gov |
| Primary | Relationship between α4β2-nAChR receptor binding VT and performance on the Spatial Attention Resource Allocation Task (SARAT) in SCZ vs. matched controls. | 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. | ClinicalTrials.gov |
| Primary | 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. | 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. | ClinicalTrials.gov |
| Primary | 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. | 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. | ClinicalTrials.gov |
| Secondary | Relationship between α4β2/α7-nAChR VT and tobacco use disorder in SCZ patients who are smokers vs. non-smoker SCZ patients treated with olanzapine. | 60-74 days | 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. | ClinicalTrials.gov |
| Secondary | Relationship between the single nucleotide polymorphism (SNP) CHRNA7 rs3087454 and race in SCZ vs. matched controls. | 60-74 days | The Primary Outcome Measure is the correlation between CHRNA7 rs3087454 and and race (non-Hispanic Caucasians and African Americans) in SCZ vs. matched controls. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)