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

      • Basel, Switzerland, 4055
        • University of Basel, Division of Cognitive Neuroscience

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.

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

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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