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



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 40
Updated:4/21/2016
Start Date:May 2013
End Date:January 2016

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

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 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.

Inclusion Criteria:

For all Individuals

- Male and female subjects

- Ages 18 - 40 years

- General intellectual abilities falling broadly within the average range (estimated 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, PCP, 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 SCID 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
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
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from
Chicago, IL
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