Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

Phase 2

Completed

• Conditions: Memory Functions
• Interventions: Drug: Cinacalcet; Drug: Placebo

• Registration Number: NCT01599962
• Lead Sponsor: Prof. Dominique de Quervain, MD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-02
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sugar pill	Placebo	-
Cinacalcet	Cinacalcet	-
Sugar pill	Cinacalcet	-

Primary Outcome Measures

Name	Time	Method
Change of attention functions under cinacalcet	two study days within 10 days
Change of memory functions under cinacalcet	two testing days within 10 days

Secondary Outcome Measures

Name	Time	Method
Change of emotional state under cinacalcet	two study days within 10 days

Trial Locations

Locations (1)

University of Basel, Division of Cognitive Neuroscience; 🇨🇭 Basel, Switzerland