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Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

NCT ID: NCT01599962

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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Conditions

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Memory Functions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cinacalcet

Group Type EXPERIMENTAL

Cinacalcet

Intervention Type DRUG

single administration, 90mg

Sugar pill

Group Type PLACEBO_COMPARATOR

Cinacalcet

Intervention Type DRUG

single administration, 90mg

Placebo

Intervention Type DRUG

single administration

Interventions

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Cinacalcet

single administration, 90mg

Intervention Type DRUG

Placebo

single administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinical Trial Unit, University Hospital Basel, Switzerland

OTHER

Sponsor Role collaborator

Prof. Dominique de Quervain, MD

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dominique de Quervain, MD

Director of the Division of Cognitive Neuroscience

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dominique de Quervain, Prof. MD

Role: STUDY_DIRECTOR

University of Basel

Locations

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University of Basel, Division of Cognitive Neuroscience

Basel, Basel, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2012DR2027

Identifier Type: -

Identifier Source: org_study_id