Memory FunctionsPhase 2Mira-BaselNCT01599962
Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects
A Phase 2 study testing Cinacalcet in people with Memory Functions, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial summary
To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Functions
- What is being tested?
- Cinacalcet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to Aug 2012
- Phase
- Phase 2
- 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
- normotensive
- native or fluent German-speaking
- caucasian (European ancestry)
- BMI between 19 and 27 kg/m2
Who cannot join
- acute or chronic psychiatric or somatic disorder
- pathological ECG
- Low serum calcium
- known hypersensitivity to the IMP
- pregnancy
- breast-feading
Show all 10Show fewer
- long-term medication within last 3 months
- smoking more than 3 cigarettes per day
- seizures in participants and first degree relatives
- concurrent participation in another study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Division of Cognitive Neuroscience
Basel, Basel, 4055
About this study
To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans.
- Conditions
- Memory Functions
- Being tested
- Cinacalcet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
single administration, 90mg
PlaceboDrug
single administration
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Experimental | Not described Receives: Drug: Cinacalcet |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Cinacalcet; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of attention functions under cinacalcet
Measured: two study days within 10 days
Change of memory functions under cinacalcet
Measured: two testing days within 10 days
Secondary outcomes (1)
Change of emotional state under cinacalcet
Measured: two study days within 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory FunctionsStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 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, Study director, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599962
- Sponsor's protocol ID
- 2012DR2027
- Acronym
- Mira-Basel
- Status last verified
- Oct 2012
- First submitted
- 2 May 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT01599962
- Acronym / sponsor ID
- Mira-Basel / 2012DR2027
- Conditions
- Memory Functions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 May 2012 (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.
To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | Experimental | Drug: Cinacalcet |
| Sugar pill | Placebo comparator | Drug: Cinacalcet, Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy
- normotensive
- native or fluent German-speaking
- caucasian (European ancestry)
- BMI between 19 and 27 kg/m2
Key exclusion criteria (10 listed)
- acute or chronic psychiatric or somatic disorder
- pathological ECG
- Low serum calcium
- known hypersensitivity to the IMP
- pregnancy
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 |
|---|---|---|
| Cinacalcetsingle administration, 90mg | Drug | Cinacalcet, Sugar pill |
| Placebosingle administration | Drug | Sugar pill |
Primary outcome
Change of attention functions under cinacalcet
Time frame: two study days within 10 days
Change of memory functions under cinacalcet
Time frame: two testing days within 10 days
1 secondary outcome
Change of emotional state under cinacalcet
Time frame: two study days within 10 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 Oct 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 study director
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cinacalcet in people with Memory Functions, 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 5 inclusion and 10 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 Oct 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of attention functions under cinacalcet (time frame: two study days within 10 days). The study lists 2 primary outcomes in all. 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 Oct 2012.