Influence of Cincalcet on Cognitive Functions in Healthy... | NCT01599962

Studies
Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects

NCT01599962

Sponsor

Prof. Dominique de Quervain, MD

Status

Completed

Last Update Posted

Oct 3, 2012Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Memory Functions

Interventions

Cinacalcet
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

May 2, 2012

First Submission Date that Met QC Criteria

May 15, 2012

First Posted Date

May 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2012

Last Update Posted Date

Oct 3, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dominique de Quervain, MD, Director of the Division of Cognitive Neuroscience, University of BaselSponsor-Investigator

Lead Sponsor

Prof. Dominique de Quervain, MDOTHER

Collaborators

Name	Class
Clinical Trial Unit, University Hospital Basel, Switzerland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cinacalcet	Experimental		Drug: Cinacalcet
Sugar pill	Placebo Comparator		Drug: Cinacalcet Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cinacalcet	Drug	single administration, 90mg	Cinacalcet Sugar pill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Change of emotional state under cinacalcet		two study days within 10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominique de Quervain, Prof. MD	University of Basel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Basel, Division of Cognitive Neuroscience		Basel	Basel	4055	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D000069449	Cinacalcet

Ancestor Terms

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided