NCT02207634

Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects

A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients With Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,974 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

Detailed description

Participants who were enrolled in study 20110118 (FOURIER; NCT01764633) at select sites in select countries (selected based on study start-up timelines) were invited to participate in this cognitive function study, 20130385. There was no separate randomization for Study 20130385; data were analyzed according to Study 20110118 randomized treatment arm.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab	Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
DRUG	Placebo	Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
DRUG	Background Statin Therapy	Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.

Timeline

• Start date: 2014-09-10
• Primary completion: 2016-11-11
• Completion: 2016-11-11
• First posted: 2014-08-04
• Last updated: 2018-01-16
• Results posted: 2018-01-16

Locations

416 sites across 30 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom