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

Healthy Clinical Trial

Official title:

Functional Neuroimaging Effects of the N-methyl-D-aspartate Receptor (NMDAR) Partial Agonist, GLYX-13, on Learning and Memory in Healthy Individuals

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01844726
• Other study ID #: STU77430
• Status: Terminated
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Mental Disorders
• Psychiatric Illness

Intervention

Drug:
• GLYX-13
Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
• Placebo
Single injection of placebo (saline)

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	within 1 hour of administration
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.	within 1 hour of administration