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
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:
Exclusion Criteria:
Woden, Australian Capital Territory 2605, Australia
Klatovy IV, 339 01, Czechia
Ostrava - Vitkovice, 703 00, Czechia
Praha 5 - Smichov, 150 00, Czechia
OYS, 90029, Finland
Montepellier Cedex, 34295, France
Ichinomiya-shi, Aichi-ken 491-8551, Japan
Kasugai-shi, Aichi-ken 487-0031, Japan
Matsudo-shi, Chiba 271-0077, Japan
Saijo-shi, Ehime 793-0030, Japan
Chikushi-gun, Fukuoka 811-1244, Japan
Itoshima-shi, Fukuoka 819-1104, Japan
Himeji-shi, Hyōgo 672-8043, Japan
Toride-shi, Ibaraki 302-0022, Japan
Okinawa-shi, Okinawa 904-8585, Japan
Shimajiri-gun, Okinawa 901-0493, Japan
Urasoe-shi, Okinawa 901-2132, Japan
Kawaguchi-shi, Saitama 332-8558, Japan
Komatsushima-shi, Tokushima 773-8502, Japan
Chuo-ku, Tokyo 103-0027, Japan