Objective

Evolocumab – To evaluate the effect of the PCSK9 inhibitor evolocumab on cognitive function in patients with established atherosclerotic cardiovascular disease receiving statin therapy.

Study Summary

Intervention

Randomized, double-blind, placebo-controlled cognitive substudy of the FOURIER trial. Patients received evolocumab (140 mg every 2 weeks or 420 mg monthly) or placebo on top of statins. Cognitive testing was performed using the CANTAB battery at baseline, 24 weeks, annually, and trial end. Primary endpoint: change in spatial working memory strategy index. Secondary endpoints: working memory errors, episodic memory, psychomotor speed.

Inclusion Criteria

Patients aged 40–85 with established cardiovascular disease and LDL ≥70 mg/dL or non-HDL ≥100 mg/dL, on stable moderate- or high-intensity statins. Excluded if dementia, mild cognitive impairment, or other cognitive confounders were present.

Study Design

Arms: Evolocumab + Statin vs. Placebo + Statin

Patients per Arm: Evolocumab: 586; Placebo: 618 (primary-analysis population)

Outcome