Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects
Mira-Basel
1 other identifier
interventional
40
1 country
1
Brief Summary
To investigate the effects of the calcimimetic agent cinacalcet on cognitive functions in healthy humans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 2, 2012
CompletedFirst Posted
Study publicly available on registry
May 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedOctober 3, 2012
October 1, 2012
5 months
May 2, 2012
October 2, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
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 (1)
Change of emotional state under cinacalcet
two study days within 10 days
Study Arms (2)
Cinacalcet
EXPERIMENTALSugar pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- healthy
- normotensive
- native or fluent German-speaking
- caucasian (European ancestry)
- BMI between 19 and 27 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Basel, Division of Cognitive Neuroscience
Basel, Basel, 4055, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dominique de Quervain, Prof. MD
University of Basel
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Division of Cognitive Neuroscience
Study Record Dates
First Submitted
May 2, 2012
First Posted
May 16, 2012
Study Start
March 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
October 3, 2012
Record last verified: 2012-10