The Influence of Glutamate on Memory in Humans

December 2, 2014 updated by: Rene Hurlemann, University Hospital, Bonn

The NMDA Receptor Co-agonist D-cycloserine Accelerates Associative Learning in the Human Hippocampal CA Region

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Juelich, NRW, Germany, 52428
        • Forschungszentrum Juelich GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Placebo condition for D-Cycloserine, fMRI
Drug: Sugar pill
20 mg, one dose, 8 hours prior
Other Names:
  • Placebo condition Memantine, fMRI
Placebo Comparator: Sugar pill, fMRI, glutamic acid
Placebo condition for D-Cycloserine, fMRI
Drug: Sugar pill
250 mg, one dose, 60 min prior
Other Names:
  • Placebo condition for D-Cycloserine, fMRI
Drug: Sugar pill
20 mg, one dose, 8 hours prior
Other Names:
  • Placebo condition Memantine, fMRI
Placebo Comparator: Sugar pill, memantine, behavioral
Placebo condition Memantine, behavioral
Drug: Sugar pill
250 mg, one dose, 60 min prior
Other Names:
  • Placebo condition for D-Cycloserine, fMRI
Drug: Sugar pill
20 mg, one dose, 8 hours prior
Other Names:
  • Placebo condition Memantine, fMRI
Placebo Comparator: Sugar pill, memantine, fMRI
Placebo condition Memantine, fMRI
Drug: Sugar pill
250 mg, one dose, 60 min prior
Other Names:
  • Placebo condition for D-Cycloserine, fMRI
Drug: Sugar pill
20 mg, one dose, 8 hours prior
Other Names:
  • Placebo condition Memantine, fMRI
Active Comparator: D-Cycloserine behavioral
Drug: Glutamic Acid
250 mg, one dose, 60 minutes prior
Other Names:
  • D-Cycloserine, King Pharmaceuticals
Active Comparator: D-Cycloserine, fMRI
Drug: Glutamic Acid
250 mg, one dose, 60 minutes prior
Other Names:
  • D-Cycloserine, King Pharmaceuticals
Active Comparator: Memantine, behavioral
Drug: Memantine
20 mg, one dose, 8 hours prior
Other Names:
  • Axura, Merz
Active Comparator: Memantine, fMRI
Drug: Memantine
20 mg, one dose, 8 hours prior
Other Names:
  • Axura, Merz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fMRI during learning task
Time Frame: once at drug administration
once at drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH999

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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