The Influence of Glutamate on Memory in Humans
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital, Bonn
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00980408
First received: September 18, 2009
Last updated: August 8, 2012
Last verified: August 2012
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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: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (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 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 8, 2012 |
| 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 Dopamine Agents Neurotransmitter Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013