Memory, Long-TermLoDi-BaselNCT01321021
Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
A study of Memory, Long-Term and Memory, Short-Term, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial summary
This project aims at identifying novel pharmacological targets for the treatment of memory disorders. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory, Long-Term, Memory, Short-Term
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2011to 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- native or fluent German-speaking
- BMI between 19 and 27 kg/m2
- able and willing to give written informed consent and comply with the requirements of the study protocol
- willing to donate saliva sample for DNA-analysis
- female: willing to perform a pregnancy test at the beginning of both test visits
Who cannot join
- acute or chronic psychiatric or somatic disorder
- pathological ECG
- known hypersensitivity to the IMP under investigation (losartan, diphenhydramine)
- hypotension (RR < 110/70 mmHg)
- bradycardia (< 50 bpm)
- pregnancy, breast-feeding
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- long-term medication within last 3 months (oral contraceptives are disregarded)
- smoking (> 3 cigarettes per day)
- concurrent participation in another study
- participation in one of our previous studies using the same memory tests
- inability to read and understand the participant's information
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Division of Cognitive Neuroscience
Basel, Basel, 4055
About this study
This project aims at identifying novel pharmacological targets for the treatment of memory disorders.
Read the detailed description
To investigate the effects of the histamine H1 receptor antagonist diphenhydramine and the angiotensin II receptor antagonist losartan on emotional and cognitive functions in healthy human subjects.
- Conditions
- Memory, Long-Term, Memory, Short-Term
- Being tested
- Losartan, Diphenhydramine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan, Diphenhydramine, PlaceboDrug
placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg
| Study group | Role | What they receive |
|---|---|---|
| Losartan, Diphenhydramine, Placebo | Experimental | placebo controlled crossover study with two arms: Losartan, Diphenhydramine Receives: Drug: Losartan, Diphenhydramine, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measures
Memory functions
Measured: during cognitive testing at study days
Secondary outcomes (1)
Secondary Outcome Measures
sleepiness, mood, anxiety, attention, fluid intelligence
Measured: during cognitive testing at study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory, Long-TermStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Dominique de Quervain, Prof. MD, Principal investigator, University of Basel, Faculty of Psychology and Medecine, Division of Cognitive Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321021
- Sponsor's protocol ID
- 2011DR2032
- Acronym
- LoDi-Basel
- Status last verified
- May 2012
- First submitted
- 22 Mar 2011
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT01321021
- Acronym / sponsor ID
- LoDi-Basel / 2011DR2032
- Conditions
- Memory, Long-Term, Memory, Short-Term
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Mar 2011 (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.
This project aims at identifying novel pharmacological targets for the treatment of memory disorders.
Detailed description
To investigate the effects of the histamine H1 receptor antagonist diphenhydramine and the angiotensin II receptor antagonist losartan on emotional and cognitive functions in healthy human subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Losartan, Diphenhydramine, Placebo | Experimental | Drug: Losartan, Diphenhydramine, Placeboplacebo controlled crossover study with two arms: Losartan, Diphenhydramine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy
- native or fluent German-speaking
- BMI between 19 and 27 kg/m2
- able and willing to give written informed consent and comply with the requirements of the study protocol
- willing to donate saliva sample for DNA-analysis
Key exclusion criteria (11 listed)
- acute or chronic psychiatric or somatic disorder
- pathological ECG
- known hypersensitivity to the IMP under investigation (losartan, diphenhydramine)
- hypotension (RR < 110/70 mmHg)
- bradycardia (< 50 bpm)
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 |
|---|---|---|
| Losartan, Diphenhydramine, Placeboplacebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg | Drug | Losartan, Diphenhydramine, Placebo |
Primary outcome
Primary Outcome Measures
Time frame: during cognitive testing at study days
Memory functions
1 secondary outcome
Secondary Outcome Measures
Time frame: during cognitive testing at study days
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 May 2012.
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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.
Dominique de Quervain, Prof. MD principal investigator
University of Basel, Faculty of Psychology and Medecine, Division of Cognitive Neuroscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Memory, Long-Term and Memory, Short-Term, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
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 6 inclusion and 11 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 May 2012. 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 Switzerland. 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. 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?
Primary Outcome Measures (time frame: during cognitive testing at study days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2012.