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The Influence of Glutamate on Memory in Humans

NCT ID: NCT00980408

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Individuals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sugar pill, behavioral glutamic acid

Placebo condition for D-Cycloserine

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

250 mg, one dose, 60 min prior

Sugar pill, fMRI, glutamic acid

Placebo condition for D-Cycloserine, fMRI

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

250 mg, one dose, 60 min prior

Sugar pill, memantine, behavioral

Placebo condition Memantine, behavioral

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

20 mg, one dose, 8 hours prior

Sugar pill, memantine, fMRI

Placebo condition Memantine, fMRI

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

20 mg, one dose, 8 hours prior

D-Cycloserine behavioral

Group Type ACTIVE_COMPARATOR

Glutamic Acid

Intervention Type DRUG

250 mg, one dose, 60 minutes prior

D-Cycloserine, fMRI

Group Type ACTIVE_COMPARATOR

Glutamic Acid

Intervention Type DRUG

250 mg, one dose, 60 minutes prior

Memantine, behavioral

Group Type ACTIVE_COMPARATOR

Memantine

Intervention Type DRUG

20 mg, one dose, 8 hours prior

Memantine, fMRI

Group Type ACTIVE_COMPARATOR

Memantine

Intervention Type DRUG

20 mg, one dose, 8 hours prior

Interventions

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Sugar pill

250 mg, one dose, 60 min prior

Intervention Type DRUG

Sugar pill

250 mg, one dose, 60 min prior

Intervention Type DRUG

Sugar pill

20 mg, one dose, 8 hours prior

Intervention Type DRUG

Sugar pill

20 mg, one dose, 8 hours prior

Intervention Type DRUG

Glutamic Acid

250 mg, one dose, 60 minutes prior

Intervention Type DRUG

Glutamic Acid

250 mg, one dose, 60 minutes prior

Intervention Type DRUG

Memantine

20 mg, one dose, 8 hours prior

Intervention Type DRUG

Memantine

20 mg, one dose, 8 hours prior

Intervention Type DRUG

Other Intervention Names

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Placebo condition for D-Cycloserine, behavioral study Placebo condition for D-Cycloserine, fMRI Placebo condition Memantine, behavioral Placebo condition Memantine, fMRI D-Cycloserine, King Pharmaceuticals D-Cycloserine, King Pharmaceuticals Axura, Merz Axura, Merz

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Rene Hurlemann

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Forschungszentrum Juelich GmbH

Jülich, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 20303474 (View on PubMed)

Other Identifiers

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RH999

Identifier Type: -

Identifier Source: org_study_id