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

This study has been completed.
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
Prof. Dominique de Quervain, MD, University of Basel
ClinicalTrials.gov Identifier:
NCT01599962
First received: May 2, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans.


Condition Intervention Phase
Memory Functions
Drug: Cinacalcet
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

Resource links provided by NLM:


Further study details as provided by University of Basel:

Primary Outcome Measures:
  • Change of attention functions under cinacalcet [ Time Frame: two study days within 10 days ] [ Designated as safety issue: No ]
  • Change of memory functions under cinacalcet [ Time Frame: two testing days within 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of emotional state under cinacalcet [ Time Frame: two study days within 10 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cinacalcet Drug: Cinacalcet
single administration, 90mg
Placebo Comparator: Sugar pill Drug: Cinacalcet
single administration, 90mg
Drug: Placebo
single administration

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 2, 2012
Last Updated: October 2, 2012
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on September 18, 2014