Study to Assess the Effect of Evolocumab on Ability to Learn Compared with Placebo in patients with Cardiovascular Disease who are already taking Statin Therapy.

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 Evolocumab (AMG 145) - EBBINGHAUS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001976-75-SE

Enrollment

4000

Registered

2014-07-30

Start date

2014-09-11

Completion date

Unknown

Last updated

2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia MedDRA version: 17.0 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861 MedDRA version: 17.0 Level: LLT Classification code 10058110 Term: Dyslipidemia System Organ Class: 100000004861

Interventions

Product Name: Evolocumab Product Code: AMG 145 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Evolocumab Current Sponsor code: Evolocumab Other descriptive name: AM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Signed informed consent for Study 20130385 2) Randomized into Study 20110118 (FOURIER) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1600

Exclusion criteria

Exclusion criteria: 1) Current or known past diagnosis of dementia or mild cognitive impairment (MCI) 2) Any condition or situation, including other significant mental or neurological disorders that, in the investigator’s opinion, may confound the study results, or may interfere significantly with the subject’s participation in Study 20130385 or in Study 20110118

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate change over time in executive function, as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory (SWM) strategy index of executive function, in subjects receiving statin therapy in combination with evolocumab, compared with subjects receiving statin therapy in combination with placebo.;Secondary Objective: To evaluate change over time in subjects receiving statin therapy in combination with evolocumab, compared with subjects receiving statin therapy in combination with placebo in the following: • Working memory, as assessed by the CANTAB Spatial Working Memory (SWM) test between-errors score • Memory function, as assessed by the CANTAB Paired Associates Learning (PAL) test • Psychomotor speed, as assessed by the CANTAB Reaction Time (RTI) test.;Primary end point(s): The primary endpoint is the SWM strategy index of executive function.;Timepoint(s) of evaluation of this end point: From baseline assessment to end of study visit assessment	—

Measure

Time frame

Main Objective: To evaluate change over time in executive function, as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory (SWM) strategy index of executive function, in subjects receiving statin therapy in combination with evolocumab, compared with subjects receiving statin therapy in combination with placebo.;Secondary Objective: To evaluate change over time in subjects receiving statin therapy in combination with evolocumab, compared with subjects receiving statin therapy in combination with placebo in the following: • Working memory, as assessed by the CANTAB Spatial Working Memory (SWM) test between-errors score • Memory function, as assessed by the CANTAB Paired Associates Learning (PAL) test • Psychomotor speed, as assessed by the CANTAB Reaction Time (RTI) test.;Primary end point(s): The primary endpoint is the SWM strategy index of executive function.;Timepoint(s) of evaluation of this end point: From baseline assessment to end of study visit assessment

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are: • SWM between-errors score • PAL total errors adjusted • RTI median 5-choice reaction time.;Timepoint(s) of evaluation of this end point: From baseline assessment to end of study visit assessment	—

Countries

Australia, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactIHQ Medical Info - Clinical Trials

Amgen (EUROPE) GmbH

MedinfoInternational@amgen.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026