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 [NCT02207634]

Description: This study evaluates change over time in neurocognitive testing in subjects receiving statin therapy in combination with evolocumab (AMG 145), compared with subjects receiving statin therapy in combination with placebo.

Biological: Evolocumab (AMG 145); Other: Placebo; Drug: Effective statin therapy

Primary Investigator: Kereiakes

Drug/Device Information
Evaluating PCSK9 binding antibody influence on cognitive health in high cardiovascular risk subjects
Evolocumab (AMG 145) is a fully human monoclonal immunoglobulin (Ig) G2 that binds specifically to human PCSK9 and prevents its interaction with the LDL receptor (LDLR)
Evaluation is done utilizing the Cambridge Neuropsychological Test Automated Battery and the study does not involve additional treatment
Major Inclusion and Exclusion
Must be randomized into study 20110118 (FOURIER)
No current or known past diagnosis of dementia or mild cognitive impairment