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

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 - EBBINGHAUS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53170

Enrollment

Registered

2015-12-24

Start date

2015-02-12

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

dyslipidemia elevated cholesterol

Interventions

At each visit the subject will complete the following 3 different CANTAB (Cambridge Neuropsychological Test Automated Battery) tests on a touch screen computer (tablet computer) at the study site. -

cardiovascular disease

cognitive function

dyslipidemia

evolocumab

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) Signed informed consent for Study 20130385 2) Randomized into Study 20110118 (FOURIER)

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
Primary endpoint: 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
Secundary endpoints: - 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, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan (Province of China), Turkey, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)