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Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects (Mira-Basel)

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ClinicalTrials.gov Identifier: NCT01599962
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : October 3, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans.

Condition or disease Intervention/treatment Phase
Memory Functions Drug: Cinacalcet Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects
Study Start Date : March 2012
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cinacalcet Drug: Cinacalcet
single administration, 90mg
Placebo Comparator: Sugar pill Drug: Cinacalcet
single administration, 90mg
Drug: Placebo
single administration


Outcome Measures

Primary Outcome Measures :
  1. Change of attention functions under cinacalcet [ Time Frame: two study days within 10 days ]
  2. Change of memory functions under cinacalcet [ Time Frame: two testing days within 10 days ]

Secondary Outcome Measures :
  1. Change of emotional state under cinacalcet [ Time Frame: two study days within 10 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599962


Locations
Switzerland
University of Basel, Division of Cognitive Neuroscience
Basel, Switzerland, 4055
Sponsors and Collaborators
Prof. Dominique de Quervain, MD
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
Study Director: Dominique de Quervain, Prof. MD University of Basel
More Information

Responsible Party: Prof. Dominique de Quervain, MD, Director of the Division of Cognitive Neuroscience, University of Basel
ClinicalTrials.gov Identifier: NCT01599962     History of Changes
Other Study ID Numbers: 2012DR2027
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs