The Influence of Glutamate on Memory in Humans

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00980408
First received: September 18, 2009
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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 Intervention
Healthy Individuals
Drug: Sugar pill
Drug: Glutamic Acid
Drug: Memantine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The NMDA Receptor Co-agonist D-cycloserine Accelerates Associative Learning in the Human Hippocampal CA Region

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • fMRI during learning task [ Time Frame: once at drug administration ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: June 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
  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: NCT00980408

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

No publications provided by University Hospital, Bonn

Additional 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
Study First Received: September 18, 2009
Last Updated: August 27, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Contraceptives, Oral
Cycloserine
Memantine
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on September 22, 2014