Influence of Cincalcet on Cognitive Functions in Healthy Human Subjects (Mira-Basel)

Prof. Dominique de Quervain, MD

Status and phase: Completed; Phase 2

Conditions: Memory Functions

Treatments: Drug: Cinacalcet; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01599962

2012DR2027

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Cinacalcet

Experimental group

Treatment:

Drug: Cinacalcet

Sugar pill

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Cinacalcet