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The purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia
Potential participants will first be given an Informed Consent document and have the study explained to them. All patients who provide written informed consent will undergo screening to determine eligibility for the study. Patients who meet all eligibility criteria will be admitted to the clinic for 5 days / 4 nights as an in-patient. During this time, participants will be assigned to a specific dose cohort and will receive sequence that includes both placebo and RL-007. Brain activity and cognitive performance will be assessed on study days 2 and 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-escalation - RL-007 | Experimental | Each cohort will include a single dose-strength. Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant. |
|
| Dose-escalation - matching Placebo | Placebo Comparator | Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RL-007 | Drug | Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAE) | Comparison of AE rates between active and placebo dosing | Study Day 8. |
| Change in blood pressure (systolic and diastolic) from baseline | blood pressure measured in mmHg; baseline = Day -1 | Study Day 4 |
| Change in heart rate from baseline | heart rate measured in beats per minute; baseline = Day -1 | Study Day 4 |
| Change in respiratory rate from baseline | respiratory rate measured in breaths per minute; baseline = Day -1 | Study Day 4 |
| Change in temperature from baseline | temperature measured in degrees Celsius; baseline = Day -1 | Study Day 4 |
| Change in electrocardiogram (ECG) from baseline | overall physician interpretation of ECG reading; baseline = Day -1 | Study Day 3 |
| Change in the Columbia Suicide Severity Rating Scale (C-SSRS) from baseline | The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1 | Study Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in quantitative electroencephalogram (qEEG) | change from baseline in amplitude across qEEG frequency bands (alpha, beta, delta, theta, and gamma) | Study Day 4 |
| Change from baseline in evoked response potential (ERP) amplitude |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal learning performance | Number of words recalled (immediate and delayed) on the Hopkins Verbal Learning Test (HVLT-R) | Study Day 4 |
| Symbol coding performance | Number of correct responses on the Brief Assessment of Cognition in Schizophrenia Symbol Coding Test |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Walling, PhD | Collaborative Neuroscience Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Research | Long Beach | California | 90806 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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Four dose cohorts will be enrolled sequentially.
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Participants will not be informed of their dose cohort or of the sequence of placebo or active capsules.
| RL-007 Matching Placebo |
| Drug |
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing |
|
Change from baseline in signal amplitude of the two-stimulus auditory oddball ERP
| Study Day 4 |
| Change from baseline in evoked response potential (ERP) latency | Change from baseline in signal latency of the two-stimulus auditory oddball ERP | Study Day 4 |
| Change from baseline in amplitude of mismatch negativity (MMN) ERP | Change from baseline in signal amplitude of the MMN ERP | Study Day 4 |
| Change from baseline in latency of mismatch negativity (MMN) ERP | Change from baseline in signal latency of the MMN ERP | Study Day 4 |
| Study Day 4 |
| Category fluency performance | Number of appropriate items provided in the Category Fluency Task | Study Day 4 |