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Study sponsor was acquired by another company.
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The present study proposes to evaluate the potential cognitive enhancing effects of GLYX-13, an NMDAR partial agonist, among a group of healthy adults and those with psychiatric illness on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.
In a single blind randomized parallel group design, we will evaluate the whether a single dose of GLYX-13 vs. placebo increases cognitive performance on tasks of learning, declarative memory, and working memory, and associated task-related increases in blood oxygen level-dependent (BOLD) activation in hippocampus and dorsolateral prefrontal cortex, respectively. Positive findings will provide biomarker evidence for GLYX-13 effects on neural systems underlying these cognitive processes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLYX-13 | Experimental | Single IV infusion of GLYX-13, 5mg/kg, |
|
| Placebo | Placebo Comparator | Single IV administration of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLYX-13 | Drug | Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Change in fMRI BOLD Signal During a Category Learning Task | Evidence of enhanced functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) signal change during a category learning task among individuals receiving GLYX-13 administration compared to those receiving placebo. Value represents fMRI BOLD signal change (in % change) across a task derived functional network. Higher scores indicate greater task-based activation across this functional circuit. | within 1 hour of administration |
| Measure | Description | Time Frame |
|---|---|---|
| Category Learning Behavioral Performance | This measure reflects the percentage of correct trials on a category learning task in which subjects learned the category membership (group A or group B) of 8 three-digit numbers presented over 64 trials. Higher values (>50%) reflect increased accuracy in learning the category membership. | within 1 hour of administration |
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Inclusion Criteria:
For all Individuals
For Patients
-Diagnosis of Schizophrenia or Schizoaffective Disorder
Exclusion Criteria:
For all individuals:
For Healthy Individuals
For Patients
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| Name | Affiliation | Role |
|---|---|---|
| James L Reilly, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GLYX-13 | Single IV infusion of GLYX-13, 5mg/kg, GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist |
| FG001 | Placebo | Single IV administration of placebo Placebo: Single injection of placebo (saline) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GLYX-13 | Single IV infusion of GLYX-13, 5mg/kg, GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist |
| BG001 | Placebo | Single IV administration of placebo Placebo: Single injection of placebo (saline) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Change in fMRI BOLD Signal During a Category Learning Task | Evidence of enhanced functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) signal change during a category learning task among individuals receiving GLYX-13 administration compared to those receiving placebo. Value represents fMRI BOLD signal change (in % change) across a task derived functional network. Higher scores indicate greater task-based activation across this functional circuit. | Posted | Mean | Standard Deviation | percentage of BOLD signal change | within 1 hour of administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLYX-13 | Single IV infusion of GLYX-13, 5mg/kg, GLYX-13: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Reilly | Northwestern University | 312-503-4809 | james.reilly@northwestern.edu |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
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| Placebo |
| Drug |
Single injection of placebo (saline) |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Estimated Intelligence Quotient (IQ) | Estimated Intelligence Quotient (IQ) reflects the standardized reading score from the Wide Range Achievement Test - 4th version (WRAT4), which is commonly used as a proxy for estimated IQ. This score has a population mean of 100 and standard deviation (SD) of 15, with higher scores reflective of higher estimated IQ. In the current protocol, subjects had estimated IQ scores falling broadly within the average range ((minimum) 80 - (maximum)119). | Mean | Standard Deviation | units on a scale |
|
Single IV administration of placebo
Placebo: Single injection of placebo (saline)
|
|
|
| Secondary | Category Learning Behavioral Performance | This measure reflects the percentage of correct trials on a category learning task in which subjects learned the category membership (group A or group B) of 8 three-digit numbers presented over 64 trials. Higher values (>50%) reflect increased accuracy in learning the category membership. | Posted | Mean | Standard Deviation | percentage of correct trials | within 1 hour of administration |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 9 |
| 21 |
| EG001 | Placebo | Single IV administration of placebo Placebo: Single injection of placebo (saline) | 0 | 21 | 0 | 21 | 9 | 21 |
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Palpitation | Cardiac disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
|
| Injection discomfort | Injury, poisoning and procedural complications | Systematic Assessment |
|
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