Effects of GLYX-13 on Learning and Memory in Healthy Individuals

This study is currently recruiting participants.
Verified February 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
James Reilly, Northwestern University
ClinicalTrials.gov Identifier:
NCT01844726
First received: April 29, 2013
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

The present study proposes to evaluate the potential cognitive enhancing effects of GLYX-13, an NMDAR partial agonist, among a group of healthy adults on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.


Condition Intervention Phase
Learning and Memory in Healthy Individuals
Drug: GLYX-13
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Functional Neuroimaging Effects of the N-methyl-D-aspartate Receptor (NMDAR) Partial Agonist, GLYX-13, on Learning and Memory in Healthy Individuals

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Enhanced neural activation underlying episodic learning, declarative memory, and working memory performance [ Time Frame: within 1 hour of administration ] [ Designated as safety issue: No ]
    Evidence of enhanced fMRI BOLD signal change during learning, declarative memory, and working memory tasks among individuals receiving GLYX-13 administration compared to those receiving placebo.


Secondary Outcome Measures:
  • Persistence of enhanced learning, declarative memory, and working memory behavioral performance [ Time Frame: within 1 week of administration ] [ Designated as safety issue: No ]
    Evidence of persistence of enhanced learning, declarative memory, and working memory behavioral performance among individuals receiving GLYX-13 administration compared to those receiving placebo.

  • Episodic learning, declarative memory, and working memory behavioral performance [ Time Frame: within 1 hour of administration ] [ Designated as safety issue: No ]
    Evidence of enhanced learning, declarative memory, and working memory performance among individuals receiving GLYX-13 administration compared to those receiving placebo.


Estimated Enrollment: 48
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLYX-13
Single IV infusion of GLYX-13, 5mg/kg,
Drug: GLYX-13
Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
Placebo Comparator: Placebo
Single IV administration of placebo
Drug: Placebo
Single injection of placebo (saline)

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No personal history of any Axis I disorder according to SCID criteria
  • No history of treatment with antidepressant, antipsychotic, stimulant, sedative/ hypnotic, mood stabilizing, or anticholinergic medications or lithium
  • No history of neurologic disorder or systemic medical condition that may interfere with central nervous system function
  • No history of seizures
  • No history of heard injury with loss of consciousness or concussion
  • No 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)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01844726

Contacts
Contact: Tatiana Karpouzian, BA 312-695-1974 t-karpouzian@northwestern.edu
Contact: Marko Mihailovic, MA 312-695-8173 marko.mihailovic@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: James L Reilly, PhD         
Sub-Investigator: John G Csernansky, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: James L Reilly, PhD Northwestern University
  More Information

No publications provided

Responsible Party: James Reilly, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01844726     History of Changes
Other Study ID Numbers: STU77430
Study First Received: April 29, 2013
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
healthy individuals
learning
memory
cognitive enhancement
fMRI

Additional relevant MeSH terms:
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014