The Influence of Glutamate on Memory in Humans

Healthy Individuals Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980408
• Other study ID #: RH999
• Status: Completed
• Phase: N/A
• First received: September 18, 2009
• Last updated: December 2, 2014
• Start date: June 2008
• Est. completion date: August 2011

Study information

• Verified date: December 2014
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Drug:
• Sugar pill
250 mg, one dose, 60 min prior
• Sugar pill
250 mg, one dose, 60 min prior
• Sugar pill
20 mg, one dose, 8 hours prior
• Sugar pill
20 mg, one dose, 8 hours prior
• Glutamic Acid
250 mg, one dose, 60 minutes prior
• Glutamic Acid
250 mg, one dose, 60 minutes prior
• Memantine
20 mg, one dose, 8 hours prior
• Memantine
20 mg, one dose, 8 hours prior

Locations

Country	Name	City	State
Germany	Forschungszentrum Juelich GmbH	Juelich	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI during learning task		once at drug administration	No