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



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - 85
Updated:1/17/2018
Start Date:September 10, 2014
End Date:November 11, 2016

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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

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.

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.

Inclusion Criteria:

- Randomized into Study 20110118 (FOURIER; NCT01764633)

Exclusion Criteria:

- Current or known past diagnosis of dementia or mild cognitive impairment (MCI)
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