Clinical trial NCT00980408: The Influence of Glutamate on Memory in Humans
Official title: The NMDA Receptor Co-agonist D-cycloserine Accelerates Associative Learning in the Human Hippocampal CA Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Individuals
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: fMRI during learning task
timeFrame: once at drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Juelich
country: Germany
facility: Forschungszentrum Juelich GmbH
state: NRW
Study officials:
References:
citation: Onur OA, Schlaepfer TE, Kukolja J, Bauer A, Jeung H, Patin A, Otte DM, Shah NJ, Maier W, Kendrick KM, Fink GR, Hurlemann R. The N-methyl-D-aspartate receptor co-agonist D-cycloserine facilitates declarative learning and hippocampal activity in humans. Biol Psychiatry. 2010 Jun 15;67(12):1205-11. doi: 10.1016/j.biopsych.2010.01.022. Epub 2010 Mar 20.