Healthy IndividualsNCT00980408
The Influence of Glutamate on Memory in Humans
A study testing Sugar pill, Glutamic Acid and Memantine in people with Healthy Individuals, run by University Hospital, Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Sugar pill, Glutamic Acid and Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- German native language or native language level
- Able to give written informed consent
- right-handed
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Forschungszentrum Juelich GmbH
Jülich, North Rhine-Westphalia, 52428
About this study
Official title: 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.
- Conditions
- Healthy Individuals
- Being tested
- Sugar pill, Glutamic Acid, Memantine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar pillDrug
Also called Placebo condition for D-Cycloserine, behavioral study
250 mg, one dose, 60 min prior
Sugar pillDrug
Also called Placebo condition for D-Cycloserine, fMRI
250 mg, one dose, 60 min prior
Sugar pillDrug
Also called Placebo condition Memantine, behavioral
20 mg, one dose, 8 hours prior
Sugar pillDrug
Also called Placebo condition Memantine, fMRI
20 mg, one dose, 8 hours prior
Glutamic AcidDrug
Also called D-Cycloserine, King Pharmaceuticals
250 mg, one dose, 60 minutes prior
Glutamic AcidDrug
Also called D-Cycloserine, King Pharmaceuticals
250 mg, one dose, 60 minutes prior
MemantineDrug
Also called Axura, Merz
20 mg, one dose, 8 hours prior
MemantineDrug
Also called Axura, Merz
20 mg, one dose, 8 hours prior
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill, behavioral glutamic acid | Placebo comparator | Placebo condition for D-Cycloserine Receives: Drug: Sugar pill |
| Sugar pill, fMRI, glutamic acid | Placebo comparator | Placebo condition for D-Cycloserine, fMRI Receives: Drug: Sugar pill |
| Sugar pill, memantine, behavioral | Placebo comparator | Placebo condition Memantine, behavioral Receives: Drug: Sugar pill |
| Sugar pill, memantine, fMRI | Placebo comparator | Placebo condition Memantine, fMRI Receives: Drug: Sugar pill |
| D-Cycloserine behavioral | Active comparator | Not described Receives: Drug: Glutamic Acid |
| D-Cycloserine, fMRI | Active comparator | Not described Receives: Drug: Glutamic Acid |
| Memantine, behavioral | Active comparator | Not described Receives: Drug: Memantine |
| Memantine, fMRI | Active comparator | Not described Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI during learning task
Measured: once at drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene Hurlemann, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980408
- Sponsor's protocol ID
- RH999
- Status last verified
- Dec 2014
- First submitted
- 18 Sep 2009
- Last updated
- 3 Dec 2014
- Results posted
- No
Publications
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.
PubMed 20303474
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NMDA Receptor Co-agonist D-cycloserine Accelerates Associative Learning in the Human Hippocampal CA Region
- ClinicalTrials.gov ID
- NCT00980408
- Acronym / sponsor ID
- RH999
- Conditions
- Healthy Individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sugar pill, behavioral glutamic acid | Placebo comparator | Drug: Sugar pillPlacebo condition for D-Cycloserine |
| Sugar pill, fMRI, glutamic acid | Placebo comparator | Drug: Sugar pillPlacebo condition for D-Cycloserine, fMRI |
| Sugar pill, memantine, behavioral | Placebo comparator | Drug: Sugar pillPlacebo condition Memantine, behavioral |
| Sugar pill, memantine, fMRI | Placebo comparator | Drug: Sugar pillPlacebo condition Memantine, fMRI |
| D-Cycloserine behavioral | Active comparator | Drug: Glutamic Acid |
| D-Cycloserine, fMRI | Active comparator | Drug: Glutamic Acid |
| Memantine, behavioral | Active comparator | Drug: Memantine |
| Memantine, fMRI | Active comparator | Drug: Memantine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- German native language or native language level
- Able to give written informed consent
- right-handed
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar pillAlso: Placebo condition for D-Cycloserine, behavioral study250 mg, one dose, 60 min prior | Drug | Sugar pill, behavioral glutamic acid |
| Sugar pillAlso: Placebo condition for D-Cycloserine, fMRI250 mg, one dose, 60 min prior | Drug | Sugar pill, fMRI, glutamic acid |
| Sugar pillAlso: Placebo condition Memantine, behavioral20 mg, one dose, 8 hours prior | Drug | Sugar pill, memantine, behavioral |
| Sugar pillAlso: Placebo condition Memantine, fMRI20 mg, one dose, 8 hours prior | Drug | Sugar pill, memantine, fMRI |
| Glutamic AcidAlso: D-Cycloserine, King Pharmaceuticals250 mg, one dose, 60 minutes prior | Drug | D-Cycloserine behavioral |
| Glutamic AcidAlso: D-Cycloserine, King Pharmaceuticals250 mg, one dose, 60 minutes prior | Drug | D-Cycloserine, fMRI |
| MemantineAlso: Axura, Merz20 mg, one dose, 8 hours prior | Drug | Memantine, behavioral |
| MemantineAlso: Axura, Merz20 mg, one dose, 8 hours prior | Drug | Memantine, fMRI |
Primary outcome
fMRI during learning task
Time frame: once at drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 20303474Onur 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.
Related trials for Healthy Individuals
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar pill, Glutamic Acid and Memantine in people with Healthy Individuals, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI during learning task (time frame: once at drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00980408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.