- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599962
Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects (Mira-Basel)
October 2, 2012 updated by: Prof. Dominique de Quervain, MD
To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Basel, Switzerland, 4055
- University of Basel, Division of Cognitive Neuroscience
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy
- normotensive
- native or fluent German-speaking
- caucasian (European ancestry)
- BMI between 19 and 27 kg/m2
Exclusion Criteria:
- acute or chronic psychiatric or somatic disorder
- pathological ECG
- Low serum calcium
- known hypersensitivity to the IMP
- pregnancy
- breast-feading
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sugar pill
|
single administration, 90mg
single administration
|
Experimental: Cinacalcet
|
single administration, 90mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of attention functions under cinacalcet
Time Frame: two study days within 10 days
|
two study days within 10 days
|
Change of memory functions under cinacalcet
Time Frame: two testing days within 10 days
|
two testing days within 10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of emotional state under cinacalcet
Time Frame: two study days within 10 days
|
two study days within 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dominique de Quervain, Prof. MD, University of Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
May 2, 2012
First Submitted That Met QC Criteria
May 15, 2012
First Posted (Estimate)
May 16, 2012
Study Record Updates
Last Update Posted (Estimate)
October 3, 2012
Last Update Submitted That Met QC Criteria
October 2, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012DR2027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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