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

Phase 2TerminatedNCT01844726

Northwestern University44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Psychiatric Illness Healthy

Interventions

GLYX-13DRUG

Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist

PlaceboDRUG

Single injection of placebo (saline)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: within 1 hour of administration

Secondary Outcomes

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.

Time frame: within 1 hour of administration

Data from ClinicalTrials.gov

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