Effects of GLYX-13 on Learning and Memory in Healthy Individuals and Those With Psychiatric Illness

Phase 2

Terminated

• Conditions: Psychiatric Illness; Healthy
• Interventions: Drug: Placebo; Drug: GLYX-13

• Registration Number: NCT01844726
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-29
• Study Start: 2013-05
• Study First Posted: 2013-05-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2023-02-25
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-31
• Last Update Submitted: 2023-03-31
• Results First Posted: 2023-04-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

For all Individuals

• Male and female subjects
• Ages 18 - 40 years
• General intellectual abilities falling broadly within the average range (estimated intelligence quotient (IQ) between 80 - 119)
• Sufficient ability to understand study requirements and provide written informed consent

For Patients

-Diagnosis of Schizophrenia or Schizoaffective Disorder

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Exclusion Criteria

For all individuals:

• History of neurologic disorder or systemic medical condition that may interfere with central nervous system function
• History of seizures
• History of heard injury with loss of consciousness or concussion
• Positive screen for drugs of abuse: cocaine, marijuana, phencyclidine, ketamine, opioid, or other agent that is being abused in the opinion of the investigator
• Females who are currently pregnant or plan to become pregnant during the study period
• History of allergy, sensitivity, or intolerance to N-methyl-D-Aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone
• History of any ferromagnetic object in the body
• Presence of any medical device or implant for which MRI is contraindicated including cardiac pacemaker, aneurysm clip, cochlear implant, copper intrauterine device (IUD), neurostimulator, or any other device deemed unsafe
• Bullet or shrapnel in body
• Metallic braces or permanent retainer
• Significant claustrophobia

For Healthy Individuals

• Personal history of any Axis I disorder according to the Structured Clinical Interview for the DSM-5 (SCID-5) criteria
• History of treatment with antidepressant, antipsychotic, stimulant,sedative/ hypnotic, mood stabilizing, or anticholinergic medications or lithium
• History among first-degree family members of any psychotic illness or major mood disorder (e.g., major depressive disorder, recurrent; bipolar I or II disorder)

For Patients

• Treatment with Clozaril
• Change in medication within 1 month
• Hospitalization within 1 month

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single IV administration of placebo
GLYX-13	GLYX-13	Single IV infusion of GLYX-13, 5mg/kg,

Primary Outcome Measures

Name	Time	Method
Percentage of Change in fMRI BOLD Signal During a Category Learning Task	within 1 hour of administration	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.

Secondary Outcome Measures

Name	Time	Method
Category Learning Behavioral Performance	within 1 hour of administration	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States