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The Influence of Glutamate on Memory in Humans

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ClinicalTrials.gov Identifier: NCT00980408
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn

Brief Summary:
The hippocampus is particularly laden with n-methyl-d-aspartate (NMDA) receptors, and is at the same time one of the most important sites in declarative memory. The rationale of this study is that the NMDA partial agonist D-Cycloserine will promote learning compared to a placebo. On the other hand, the NMDA receptor antagonist Memantine might lead to reduced memory. We believe that the influence of NMDA receptors on memory can be determined via acute co-activation of the NMDA receptors with Cycloserine® (King Pharmaceuticals Ltd, active ingredient: DCycloserin, dose: 250 mg) and Memantine (Axura®, Merz, active ingredient: Memantine, dose: 20 mg)on both a behavioral and functional (fMRI) level.

Condition or disease Intervention/treatment Phase
Healthy Individuals Drug: Sugar pill Drug: Glutamic Acid Drug: Memantine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The NMDA Receptor Co-agonist D-cycloserine Accelerates Associative Learning in the Human Hippocampal CA Region
Study Start Date : June 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Placebo Comparator: Sugar pill, behavioral glutamic acid
Placebo condition for D-Cycloserine
Drug: Sugar pill
250 mg, one dose, 60 min prior
Other Name: Placebo condition for D-Cycloserine, behavioral study

Placebo Comparator: Sugar pill, fMRI, glutamic acid
Placebo condition for D-Cycloserine, fMRI
Drug: Sugar pill
250 mg, one dose, 60 min prior
Other Name: Placebo condition for D-Cycloserine, fMRI

Placebo Comparator: Sugar pill, memantine, behavioral
Placebo condition Memantine, behavioral
Drug: Sugar pill
20 mg, one dose, 8 hours prior
Other Name: Placebo condition Memantine, behavioral

Placebo Comparator: Sugar pill, memantine, fMRI
Placebo condition Memantine, fMRI
Drug: Sugar pill
20 mg, one dose, 8 hours prior
Other Name: Placebo condition Memantine, fMRI

Active Comparator: D-Cycloserine behavioral Drug: Glutamic Acid
250 mg, one dose, 60 minutes prior
Other Name: D-Cycloserine, King Pharmaceuticals

Active Comparator: D-Cycloserine, fMRI Drug: Glutamic Acid
250 mg, one dose, 60 minutes prior
Other Name: D-Cycloserine, King Pharmaceuticals

Active Comparator: Memantine, behavioral Drug: Memantine
20 mg, one dose, 8 hours prior
Other Name: Axura, Merz

Active Comparator: Memantine, fMRI Drug: Memantine
20 mg, one dose, 8 hours prior
Other Name: Axura, Merz




Primary Outcome Measures :
  1. fMRI during learning task [ Time Frame: once at drug administration ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • German native language or native language level
  • Able to give written informed consent
  • right-handed

Exclusion Criteria:

  • inability to give written informed consent, underaged minors, contractually incapable persons, persons in legal custody
  • any psychiatric, neurological or internal illness
  • hematoporphyria (enzyme sickness)
  • intake of medication (except oral contraceptives)
  • simultaneous participation in other clinical studies
  • hypersensitivity to Memantine or other anti-dementia substances, or to D-Cycloserine
  • alcohol abuse
  • epilepsy
  • depression
  • serious anxiety or psychosis
  • serious kidney insufficiency
  • intake of Ethionamide or Isoniazide
  • pregnancy or women who are nursing
  • liver or kidney problems
  • intake of NMDA-antagonists, such as Amantadine, Ketamine, or Dextromethorphan
  • vegetarians
  • stomach ulcer, if treated with medication
  • renal tubular acidosis
  • urinary infections (with proteus bacteria)
  • recent heart attack, heart failure, or uncontrolled high blood pressure
  • intake of L-Dopa, dopaminergic agonists, and anticholinergics
  • intake of barbiturates, spasmolytics, Phenytoin, Amantadine, oral coagulators, warfarin, HCT (Hydrochlorothiazide)
  • heart or cranial operations
  • pacemaker, medication pump (such as insulin pump), hearing aid, removable prosthodontics
  • metal in or on body (such as acupuncture needles, artificial limbs, stents, metal splints, clips, implanted electrodes, tattoos, or piercings)
  • claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980408


Locations
Germany
Forschungszentrum Juelich GmbH
Juelich, NRW, Germany, 52428
Sponsors and Collaborators
University Hospital, Bonn

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rene Hurlemann, MD, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT00980408     History of Changes
Other Study ID Numbers: RH999
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Memantine
Cycloserine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites