Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

Memory Functions Clinical Trial

— Mira-Basel  

Official title:

Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599962
• Other study ID #: 2012DR2027
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2012
• Last updated: October 2, 2012
• Start date: March 2012
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Memory Functions

Intervention

Drug:
• Cinacalcet
single administration, 90mg
• Placebo
single administration

Locations

Country	Name	City	State
Switzerland	University of Basel, Division of Cognitive Neuroscience	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD	Clinical Trial Unit, University Hospital Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of attention functions under cinacalcet		two study days within 10 days	No
Primary	Change of memory functions under cinacalcet		two testing days within 10 days	No
Secondary	Change of emotional state under cinacalcet		two study days within 10 days	No