Trial record 18 of 271 for:    Open Studies | "Memory"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 22, 2014
Last verified: May 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 and those with psychiatric illness on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.


Condition Intervention Phase
Learning and Memory in Healthy Individuals and Those With Psychiatric Illness
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: February 2015
Estimated Primary Completion Date: December 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:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 22, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Mental Disorders
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 August 20, 2014