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

December 15, 2017 updated by: Amgen

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.

Study Overview

Status

Completed

Conditions

Dyslipidemia

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1974

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Australian Capital Territory
  - Woden, Australian Capital Territory, Australia, 2605
    - Research Site
- Queensland
  - Auchenflower, Queensland, Australia, 4066
    - Research Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Research Site
  - Ashford, South Australia, Australia, 5035
    - Research Site
  - Fullarton, South Australia, Australia, 5063
    - Research Site
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Research Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Research Site
  - Epping, Victoria, Australia, 3076
    - Research Site
  - Geelong, Victoria, Australia, 3220
    - Research Site
Belgium
- - Aalst, Belgium, 9300
    - Research Site
  - Bonheiden, Belgium, 2820
    - Research Site
  - Brussels, Belgium, 1070
    - Research Site
  - Brussels, Belgium, 1020
    - Research Site
  - Gozee, Belgium, 6534
    - Research Site
  - Ieper, Belgium, 8900
    - Research Site
  - La Louvière, Belgium, 7100
    - Research Site
  - Liege, Belgium, 4000
    - Research Site
  - Liège, Belgium, 4000
    - Research Site
Canada
- - Quebec, Canada, G1V 4M6
    - Research Site
- Newfoundland and Labrador
  - St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
    - Research Site
- Ontario
  - London, Ontario, Canada, N6C 0A7
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 5G8
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 8C3
    - Research Site
  - Peterborough, Ontario, Canada, K9J 0B2
    - Research Site
  - Sarnia, Ontario, Canada, N7T 4X3
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 7K9
    - Research Site
  - Gatineau, Quebec, Canada, J8Y 6S8
    - Research Site
  - Pointe-Claire, Quebec, Canada, H9R 3J1
    - Research Site
  - St Jean sur Richelieu, Quebec, Canada, J3A 1C3
    - Research Site
  - St-Jérôme, Quebec, Canada, J7Z 5T3
    - Research Site
Czechia
- - Beroun, Czechia, 266 01
    - Research Site
  - Bilovec, Czechia, 743 01
    - Research Site
  - Brandys nad Labem, Czechia, 250 01
    - Research Site
  - Brno, Czechia, 602 00
    - Research Site
  - Brno, Czechia, 636 00
    - Research Site
  - Brno, Czechia, 638 00
    - Research Site
  - Chomutov, Czechia, 430 02
    - Research Site
  - Havlickuv Brod, Czechia, 580 22
    - Research Site
  - Hodonin, Czechia, 695 01
    - Research Site
  - Klatovy IV, Czechia, 339 01
    - Research Site
  - Liberec, Czechia, 460 63
    - Research Site
  - Litomysl, Czechia, 570 14
    - Research Site
  - Mohelnice, Czechia, 789 85
    - Research Site
  - Olomouc, Czechia, 779 00
    - Research Site
  - Ostrava - Vitkovice, Czechia, 703 00
    - Research Site
  - Pardubice, Czechia, 530 02
    - Research Site
  - Praha 10, Czechia, 101 00
    - Research Site
  - Praha 2, Czechia, 128 08
    - Research Site
  - Praha 3, Czechia, 130 00
    - Research Site
  - Praha 4, Czechia, 140 21
    - Research Site
  - Praha 5 - Smichov, Czechia, 150 00
    - Research Site
  - Prerov, Czechia, 750 02
    - Research Site
  - Uherske Hradiste, Czechia, 686 01
    - Research Site
Denmark
- - Aalborg, Denmark, 9000
    - Research Site
  - Ballerup, Denmark, 2750
    - Research Site
  - Esbjerg, Denmark, 6700
    - Research Site
  - Hvidovre, Denmark, 2650
    - Research Site
  - København S, Denmark, 2300
    - Research Site
  - Køge, Denmark, 4600
    - Research Site
  - Vejle, Denmark, 7100
    - Research Site
Estonia
- - Paide, Estonia, 72713
    - Research Site
  - Tallinn, Estonia, 13419
    - Research Site
  - Tallinn, Estonia, 10128
    - Research Site
  - Tallinn, Estonia, 10138
    - Research Site
Finland
- - Helsinki, Finland, 00290
    - Research Site
  - Helsinki, Finland, 00180
    - Research Site
  - Jyväskylä, Finland, 40100
    - Research Site
  - Kuopio, Finland, 70100
    - Research Site
  - OYS, Finland, 90029
    - Research Site
  - Oulu, Finland, 90100
    - Research Site
  - Tampere, Finland, 33100
    - Research Site
  - Turku, Finland, 20100
    - Research Site
France
- - Besançon Cedex, France, 25030
    - Research Site
  - Le Coudray, France, 28630
    - Research Site
  - Montepellier Cedex, France, 34295
    - Research Site
  - Nantes Cedex 1, France, 44093
    - Research Site
  - Paris, France, 75013
    - Research Site
  - Pessac Cedex, France, 33604
    - Research Site
  - Toulouse Cedex 9, France, 31059
    - Research Site
Germany
- - Bad Krozingen, Germany, 79189
    - Research Site
  - Berlin, Germany, 10787
    - Research Site
  - Berlin, Germany, 13353
    - Research Site
  - Berlin, Germany, 12559
    - Research Site
  - Bochum, Germany, 44787
    - Research Site
  - Dresden, Germany, 01307
    - Research Site
  - Frankfurt am Main, Germany, 60596
    - Research Site
  - Hamburg, Germany, 20246
    - Research Site
  - Hannover, Germany, 30159
    - Research Site
  - Köln, Germany, 50937
    - Research Site
  - Leipzig, Germany, 04103
    - Research Site
  - Stuttgart, Germany, 70376
    - Research Site
  - Witten, Germany, 58455
    - Research Site
  - Wuppertal, Germany, 42117
    - Research Site
Greece
- - Alexandroupoli, Greece, 68100
    - Research Site
  - Athens, Greece, 14233
    - Research Site
  - Athens, Greece, 11521
    - Research Site
  - Athens, Greece, 14561
    - Research Site
  - Ioannina, Greece, 45500
    - Research Site
  - Larissa, Greece, 41110
    - Research Site
  - Piraeus, Greece, 18536
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong
    - Research Site
Hungary
- - Bekescsaba, Hungary, 5600
    - Research Site
  - Berettyoujfalu, Hungary, 4100
    - Research Site
  - Budapest, Hungary, 1036
    - Research Site
  - Nyiregyhaza, Hungary, 4400
    - Research Site
  - Pecs, Hungary, 7624
    - Research Site
  - Szeged, Hungary, 6725
    - Research Site
  - Szekszard, Hungary, 7100
    - Research Site
  - Szikszo, Hungary, 3800
    - Research Site
  - Zalaegerszeg, Hungary, 8900
    - Research Site
Italy
- - Pavia, Italy, 27100
    - Research Site
Japan
- Aichi
  - Ichinomiya-shi, Aichi, Japan, 491-8551
    - Research Site
  - Kasugai-shi, Aichi, Japan, 487-0031
    - Research Site
  - Nagoya-shi, Aichi, Japan, 460-0001
    - Research Site
  - Nagoya-shi, Aichi, Japan, 451-8511
    - Research Site
  - Nagoya-shi, Aichi, Japan, 457-8511
    - Research Site
  - Toyohashi-shi, Aichi, Japan, 440-8510
    - Research Site
- Chiba
  - Matsudo-shi, Chiba, Japan, 271-0077
    - Research Site
- Ehime
  - Saijo-shi, Ehime, Japan, 793-0030
    - Research Site
- Fukuoka
  - Chikushi-gun, Fukuoka, Japan, 811-1244
    - Research Site
  - Fukuoka-shi, Fukuoka, Japan, 814-0180
    - Research Site
  - Fukuoka-shi, Fukuoka, Japan, 814-8522
    - Research Site
  - Itoshima-shi, Fukuoka, Japan, 819-1104
    - Research Site
- Hokkaido
  - Sapporo-shi, Hokkaido, Japan, 060-0031
    - Research Site
- Hyogo
  - Himeji-shi, Hyogo, Japan, 672-8043
    - Research Site
- Ibaraki
  - Toride-shi, Ibaraki, Japan, 302-0022
    - Research Site
  - Tsukuba-city, Ibaraki, Japan, 305-8558
    - Research Site
- Kyoto
  - Kyoto-shi, Kyoto, Japan, 615-0035
    - Research Site
- Okinawa
  - Okinawa-shi, Okinawa, Japan, 904-8585
    - Research Site
  - Shimajiri-gun, Okinawa, Japan, 901-0493
    - Research Site
  - Urasoe-shi, Okinawa, Japan, 901-2132
    - Research Site
- Osaka
  - Osaka-shi, Osaka, Japan, 530-0001
    - Research Site
  - Osaka-shi, Osaka, Japan, 543-0035
    - Research Site
- Saga
  - Saga-shi, Saga, Japan, 840-8571
    - Research Site
  - Saga-shi, Saga, Japan, 849-0917
    - Research Site
- Saitama
  - Kawaguchi-shi, Saitama, Japan, 332-8558
    - Research Site
- Tokushima
  - Komatsushima-shi, Tokushima, Japan, 773-8502
    - Research Site
- Tokyo
  - Chuo-ku, Tokyo, Japan, 103-0027
    - Research Site
Latvia
- - Daugavpils, Latvia, 5417
    - Research Site
  - Kuldiga, Latvia, LV-3301
    - Research Site
  - Liepaja, Latvia, 3402
    - Research Site
  - Ogre, Latvia, 5001
    - Research Site
  - Ogre, Latvia, LV-5003
    - Research Site
  - Riga, Latvia, 1012
    - Research Site
  - Riga, Latvia, LV-1001
    - Research Site
Lithuania
- - Vilnius, Lithuania, 10323
    - Research Site
Malaysia
- - Kuala Lumpur, Malaysia, 59100
    - Research Site
- Wilayah Persekutuan
  - Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
    - Research Site
Netherlands
- - Arnhem, Netherlands, 6815 AD
    - Research Site
  - Ede, Netherlands, 6716 RP
    - Research Site
  - Eindhoven, Netherlands, 5623 EJ
    - Research Site
  - Hoorn, Netherlands, 1625 HV
    - Research Site
  - Uden, Netherlands, 5406 PT
    - Research Site
New Zealand
- - Christchurch, New Zealand, 8011
    - Research Site
  - Tauranga, New Zealand, 3143
    - Research Site
Norway
- - Hamar, Norway, 2317
    - Research Site
  - Lierskogen, Norway, 3420
    - Research Site
  - Oslo, Norway, 0450
    - Research Site
  - Skedsmokorset, Norway, 2020
    - Research Site
  - Skien, Norway, 3710
    - Research Site
  - Stavanger, Norway, 4005
    - Research Site
  - Ålesund, Norway, 6003
    - Research Site
Poland
- - Gdansk, Poland, 80-952
    - Research Site
  - Gdynia, Poland, 81-384
    - Research Site
  - Gdynia, Poland, 81-402
    - Research Site
  - Katowice, Poland, 40-040
    - Research Site
  - Katowice, Poland, 40-084
    - Research Site
  - Katowice, Poland, 40-018
    - Research Site
  - Kielce, Poland, 25-020
    - Research Site
  - Krakow, Poland, 31-216
    - Research Site
  - Krakow, Poland, 32-082
    - Research Site
  - Lodz, Poland, 91-347
    - Research Site
  - Lodz, Poland, 90-368
    - Research Site
  - Lublin, Poland, 20-857
    - Research Site
  - Olsztyn, Poland, 10-010
    - Research Site
  - Poznan, Poland, 60-702
    - Research Site
  - Pulawy, Poland, 24-100
    - Research Site
  - Ruda Slaska, Poland, 41-709
    - Research Site
  - Staszow, Poland, 28-200
    - Research Site
  - Swidnik, Poland, 21-040
    - Research Site
  - Tarnow, Poland, 33-100
    - Research Site
  - Torun, Poland, 87-100
    - Research Site
  - Warszawa, Poland, 01-192
    - Research Site
  - Warszawa, Poland, 02-507
    - Research Site
  - Warszawa, Poland, 04-730
    - Research Site
  - Wloclawek, Poland, 87-800
    - Research Site
  - Wroclaw, Poland, 50-088
    - Research Site
  - Wroclaw, Poland, 50-349
    - Research Site
  - Wroclaw, Poland, 51-685
    - Research Site
  - Zamosc, Poland, 22-400
    - Research Site
Portugal
- - Almada, Portugal, 2801-951
    - Research Site
  - Carnaxide, Portugal, 2790-134
    - Research Site
  - Coimbra, Portugal, 3000-075
    - Research Site
  - Covilha, Portugal, 6200-251
    - Research Site
Russian Federation
- - Ekaterinburg, Russian Federation, 620144
    - Research Site
  - Ivanovo, Russian Federation, 153012
    - Research Site
  - Izhevsk, Russian Federation, 426063
    - Research Site
  - Kemerovo, Russian Federation, 650002
    - Research Site
  - Kemerovo, Russian Federation, 650099
    - Research Site
  - Kirov, Russian Federation, 610014
    - Research Site
  - Moscow, Russian Federation, 121552
    - Research Site
  - Moscow, Russian Federation, 117292
    - Research Site
  - Nizhniy Novgorod, Russian Federation, 603076
    - Research Site
  - Novosibirsk, Russian Federation, 630089
    - Research Site
  - Omsk, Russian Federation, 644018
    - Research Site
  - Pushkin, Russian Federation, 196601
    - Research Site
  - Saint Petersburg, Russian Federation, 192242
    - Research Site
  - Saint Petersburg, Russian Federation, 197022
    - Research Site
  - Saint-Petersburg, Russian Federation, 199106
    - Research Site
  - Saratov, Russian Federation, 410054
    - Research Site
  - St. Petersburg, Russian Federation, 191015
    - Research Site
  - Tomsk, Russian Federation, 634012
    - Research Site
Slovakia
- - Bardejov, Slovakia, 085 01
    - Research Site
  - Brezno, Slovakia, 977 42
    - Research Site
  - Kosice, Slovakia, 040 22
    - Research Site
  - Lucenec, Slovakia, 984 01
    - Research Site
  - Moldava nad Bodvou, Slovakia, 045 01
    - Research Site
  - Nove Zamky, Slovakia, 940 01
    - Research Site
  - Rimavska Sobota, Slovakia, 979 01
    - Research Site
  - Roznava, Slovakia, 048 01
    - Research Site
  - Snina, Slovakia, 069 01
    - Research Site
  - Svidnik, Slovakia, 08901
    - Research Site
  - Trencin, Slovakia, 911 01
    - Research Site
  - Trnava, Slovakia, 917 01
    - Research Site
South Africa
- - Cape Town, South Africa, 7530
    - Research Site
  - Kempton Park, South Africa, 1619
    - Research Site
- Gauteng
  - Centurion, Gauteng, South Africa, 0158
    - Research Site
  - Johannesburg, Gauteng, South Africa, 2196
    - Research Site
  - Johannesburg, Gauteng, South Africa, 1724
    - Research Site
  - Pretoria, Gauteng, South Africa, 0184
    - Research Site
  - Pretoria west, Gauteng, South Africa, 0183
    - Research Site
- Western Cape
  - Paarl, Western Cape, South Africa, 7646
    - Research Site
  - Parow, Western Cape, South Africa, 7505
    - Research Site
  - Somerset West, Western Cape, South Africa, 7130
    - Research Site
  - Worcester, Western Cape, South Africa, 6850
    - Research Site
Spain
- - Madrid, Spain, 28034
    - Research Site
- Aragón
  - Zaragoza, Aragón, Spain, 50009
    - Research Site
- Cataluña
  - L'Hospitalet de Llobregat, Cataluña, Spain, 08907
    - Research Site
- Comunidad Valenciana
  - Valencia, Comunidad Valenciana, Spain, 46010
    - Research Site
- Galicia
  - Santiago de Compostela, Galicia, Spain, 15706
    - Research Site
  - Vigo, Galicia, Spain, 36200
    - Research Site
- País Vasco
  - Galdakao, País Vasco, Spain, 48960
    - Research Site
Sweden
- - Helsingborg, Sweden, 251 87
    - Research Site
  - Linköping, Sweden, 581 85
    - Research Site
  - Lund, Sweden, 222 21
    - Research Site
  - Stockholm, Sweden, 171 76
    - Research Site
  - Stockholm, Sweden, 111 35
    - Research Site
  - Uddevalla, Sweden, 451 50
    - Research Site
  - Västerås, Sweden, 721 89
    - Research Site
Turkey
- - Adana, Turkey, 01330
    - Research Site
  - Ankara, Turkey, 06100
    - Research Site
  - Gaziantep, Turkey, 27310
    - Research Site
  - Istanbul, Turkey, 34096
    - Research Site
  - Istanbul, Turkey, 34865
    - Research Site
  - Izmir, Turkey, 35100
    - Research Site
  - Kocaeli, Turkey, 41380
    - Research Site
United Kingdom
- - Belfast, United Kingdom, BT7 2EB
    - Research Site
  - Birmingham, United Kingdom, B18 7QH
    - Research Site
  - Birmingham, United Kingdom, B15 2SQ
    - Research Site
  - Bournemouth, United Kingdom, BH7 7DW
    - Research Site
  - Cardiff, United Kingdom, CF14 5GJ
    - Research Site
  - Chesterfield, United Kingdom, S40 4AA
    - Research Site
  - Chippenham, United Kingdom, SN15 2SB
    - Research Site
  - Chorley, United Kingdom, PR7 7NA
    - Research Site
  - Doncaster, United Kingdom, DN9 1EP
    - Research Site
  - Glasgow, United Kingdom, G20 0SP
    - Research Site
  - Glasgow, United Kingdom, G45 9AW
    - Research Site
  - Hexham, United Kingdom, NE46 1QJ
    - Research Site
  - Leicester, United Kingdom, LE3 9QP
    - Research Site
  - Liverpool, United Kingdom, L22 0LG
    - Research Site
  - Liverpool, United Kingdom, L9 7AL
    - Research Site
  - London, United Kingdom, EC1M 6BQ
    - Research Site
  - London, United Kingdom, W2 1LA
    - Research Site
  - Manchester, United Kingdom, M15 6SX
    - Research Site
  - Manchester, United Kingdom, M23 9LT
    - Research Site
  - Newport, United Kingdom, PO30 5TG
    - Research Site
  - Nuneaton, United Kingdom, CV10 7DJ
    - Research Site
  - Reading, United Kingdom, RG2 0TG
    - Research Site
  - Sandbach, United Kingdom, CW11 1EQ
    - Research Site
  - Sheffield, United Kingdom, S5 7AU
    - Research Site
  - West Bromwich, United Kingdom, B71 4HJ
    - Research Site
  - Whitby, United Kingdom, YO21 1SD
    - Research Site
  - Worcester, United Kingdom, WR5 1DD
    - Research Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - Research Site
  - Huntsville, Alabama, United States, 35801
    - Research Site
  - Mobile, Alabama, United States, 36608
    - Research Site
- Arizona
  - Glendale, Arizona, United States, 85306
    - Research Site
  - Phoenix, Arizona, United States, 85018
    - Research Site
- California
  - Alhambra, California, United States, 91801
    - Research Site
  - Banning, California, United States, 92220
    - Research Site
  - Harbor City, California, United States, 90710
    - Research Site
  - Laguna Hills, California, United States, 92653
    - Research Site
  - Long Beach, California, United States, 90807
    - Research Site
  - Long Beach, California, United States, 90822
    - Research Site
  - Oceanside, California, United States, 92056
    - Research Site
  - Oxnard, California, United States, 93030
    - Research Site
  - Palm Springs, California, United States, 92262
    - Research Site
  - Roseville, California, United States, 95661
    - Research Site
  - Sacramento, California, United States, 95816
    - Research Site
  - San Pedro, California, United States, 90732
    - Research Site
  - Tarzana, California, United States, 91356
    - Research Site
  - Thousand Oaks, California, United States, 91360
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80012
    - Research Site
  - Colorado Springs, Colorado, United States, 80909
    - Research Site
  - Denver, Colorado, United States, 80218
    - Research Site
- Connecticut
  - Bridgeport, Connecticut, United States, 06610
    - Research Site
- Florida
  - Boynton Beach, Florida, United States, 33472
    - Research Site
  - Crystal River, Florida, United States, 34429
    - Research Site
  - Daytona Beach, Florida, United States, 32117
    - Research Site
  - Deerfield Beach, Florida, United States, 33442
    - Research Site
  - Fleming Island, Florida, United States, 32003
    - Research Site
  - Hollywood, Florida, United States, 33021
    - Research Site
  - Hollywood, Florida, United States, 33024
    - Research Site
  - Jacksonville, Florida, United States, 32216
    - Research Site
  - Miami, Florida, United States, 33144
    - Research Site
  - Palm Harbor, Florida, United States, 34684
    - Research Site
  - Pembroke Pines, Florida, United States, 33025
    - Research Site
  - Ponte Vedra, Florida, United States, 32081
    - Research Site
  - Saint Petersburg, Florida, United States, 33713
    - Research Site
  - Sarasota, Florida, United States, 34232
    - Research Site
  - Tampa, Florida, United States, 33614
    - Research Site
  - West Palm Beach, Florida, United States, 33401
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Research Site
  - Augusta, Georgia, United States, 30909
    - Research Site
  - Gainesville, Georgia, United States, 30501
    - Research Site
  - Savannah, Georgia, United States, 31406
    - Research Site
  - Suwanee, Georgia, United States, 30024
    - Research Site
- Idaho
  - Coeur d'Alene, Idaho, United States, 83814
    - Research Site
- Illinois
  - Addison, Illinois, United States, 60101
    - Research Site
  - Belleville, Illinois, United States, 62220
    - Research Site
  - Chicago, Illinois, United States, 60616
    - Research Site
  - Jerseyville, Illinois, United States, 62052
    - Research Site
- Indiana
  - Hammond, Indiana, United States, 46320
    - Research Site
- Iowa
  - Waterloo, Iowa, United States, 50702
    - Research Site
- Kansas
  - Hutchinson, Kansas, United States, 67502
    - Research Site
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Research Site
  - Owensboro, Kentucky, United States, 42303
    - Research Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Research Site
  - Hammond, Louisiana, United States, 70403
    - Research Site
  - Lafayette, Louisiana, United States, 70508
    - Research Site
  - Metairie, Louisiana, United States, 70006
    - Research Site
  - Monroe, Louisiana, United States, 71201
    - Research Site
  - Slidell, Louisiana, United States, 70458
    - Research Site
- Maine
  - Biddeford, Maine, United States, 04005
    - Research Site
- Maryland
  - Salisbury, Maryland, United States, 21804
    - Research Site
  - Towson, Maryland, United States, 21204
    - Research Site
- Massachusetts
  - Haverhill, Massachusetts, United States, 01830
    - Research Site
  - Newton, Massachusetts, United States, 02459
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Research Site
  - Grandville, Michigan, United States, 49418
    - Research Site
  - Lansing, Michigan, United States, 48912
    - Research Site
  - Muskegon, Michigan, United States, 49444
    - Research Site
- Minnesota
  - Saint Paul, Minnesota, United States, 55102
    - Research Site
- Missouri
  - Jefferson City, Missouri, United States, 65109
    - Research Site
  - Saint Louis, Missouri, United States, 63117
    - Research Site
  - Saint Louis, Missouri, United States, 63128
    - Research Site
- Montana
  - Great Falls, Montana, United States, 59405
    - Research Site
  - Kalispell, Montana, United States, 59901
    - Research Site
- New Jersey
  - Voorhees, New Jersey, United States, 08043
    - Research Site
  - Westwood, New Jersey, United States, 07675
    - Research Site
- New York
  - Brooklyn, New York, United States, 11206
    - Research Site
  - Buffalo, New York, United States, 14215
    - Research Site
  - Cortlandt Manor, New York, United States, 10567
    - Research Site
  - New Hyde Park, New York, United States, 11042
    - Research Site
  - New Windsor, New York, United States, 12553
    - Research Site
  - Rochester, New York, United States, 14609
    - Research Site
  - Troy, New York, United States, 12180
    - Research Site
  - West Seneca, New York, United States, 14224
    - Research Site
  - Williamsville, New York, United States, 14221
    - Research Site
- North Carolina
  - Calabash, North Carolina, United States, 28467
    - Research Site
  - Hickory, North Carolina, United States, 28602
    - Research Site
  - Hickory, North Carolina, United States, 28601
    - Research Site
  - Mooresville, North Carolina, United States, 28117
    - Research Site
  - Raleigh, North Carolina, United States, 27609
    - Research Site
  - Tabor City, North Carolina, United States, 28463
    - Research Site
  - Winston-Salem, North Carolina, United States, 27103
    - Research Site
- North Dakota
  - Grand Forks, North Dakota, United States, 58201
    - Research Site
- Ohio
  - Canton, Ohio, United States, 44708
    - Research Site
  - Cincinnati, Ohio, United States, 45219
    - Research Site
  - Columbus, Ohio, United States, 43215
    - Research Site
  - Columbus, Ohio, United States, 43201
    - Research Site
  - Dayton, Ohio, United States, 45414
    - Research Site
  - Springfield, Ohio, United States, 45505
    - Research Site
  - Toledo, Ohio, United States, 43615
    - Research Site
- Oklahoma
  - Pryor, Oklahoma, United States, 74362
    - Research Site
- Oregon
  - Bend, Oregon, United States, 97701
    - Research Site
  - Portland, Oregon, United States, 97239
    - Research Site
  - Portland, Oregon, United States, 97225
    - Research Site
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - Research Site
  - Chambersburg, Pennsylvania, United States, 17201
    - Research Site
  - Feasterville, Pennsylvania, United States, 19053
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19152
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15206
    - Research Site
- Rhode Island
  - Pawtucket, Rhode Island, United States, 02860
    - Research Site
- South Carolina
  - Fort Mill, South Carolina, United States, 29707
    - Research Site
  - Moncks Corner, South Carolina, United States, 29461
    - Research Site
  - Mount Pleasant, South Carolina, United States, 29464
    - Research Site
  - North Myrtle Beach, South Carolina, United States, 29582
    - Research Site
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Research Site
- Tennessee
  - Jackson, Tennessee, United States, 38305
    - Research Site
  - Nashville, Tennessee, United States, 37203
    - Research Site
  - Tullahoma, Tennessee, United States, 37388
    - Research Site
- Texas
  - Austin, Texas, United States, 78758
    - Research Site
  - Dallas, Texas, United States, 75216
    - Research Site
  - Houston, Texas, United States, 77030
    - Research Site
  - Houston, Texas, United States, 77025
    - Research Site
  - Plano, Texas, United States, 75024
    - Research Site
  - Wichita Falls, Texas, United States, 76301
    - Research Site
- Utah
  - West Jordan, Utah, United States, 84088
    - Research Site
- Virginia
  - Burke, Virginia, United States, 22015
    - Research Site
  - Falls Church, Virginia, United States, 22042
    - Research Site
  - Hopewell, Virginia, United States, 23860
    - Research Site
  - Richmond, Virginia, United States, 23294
    - Research Site
  - Richmond, Virginia, United States, 23219
    - Research Site
  - Suffolk, Virginia, United States, 23435
    - Research Site
- Washington
  - Seattle, Washington, United States, 98195
    - Research Site
- Wisconsin
  - Green Bay, Wisconsin, United States, 54301
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Randomized into Study 20110118 (FOURIER; NCT01764633)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.	Drug: Placebo Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. Drug: Background Statin Therapy Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.
Experimental: Evolocumab Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.	Biological: Evolocumab Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. Other Names: Repatha AMG 145 Drug: Background Statin Therapy Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.

Participant Group / Arm

Intervention / Treatment

Placebo Comparator: Placebo

Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.

Drug: Placebo

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Drug: Background Statin Therapy

Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.

Experimental: Evolocumab

Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.

Biological: Evolocumab

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Other Names:

Repatha
AMG 145

Drug: Background Statin Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score Time Frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).	Assessments were performed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) test assesses the cognitive domain of executive function (high-level thinking and decision making). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM strategy index of executive function represented the number of times a subject began a search with a different box. The Z score represents the standardized measure of how far an individual subject deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.	Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score Time Frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).	Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) between-errors test assesses the cognitive domain of working memory (holding material in mind while that material is being actively processed). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM between-errors score is the number of times that a patient revisited a box in which a token had previously been found. The Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.	Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).
Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score Time Frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).	The CANTAB PAL test assesses visuospatial episodic memory (storing/retrieving information by associating an event with a time and place). Boxes on the screen opened up one at a time to reveal a number of patterns. Participants were asked to remember the location of each pattern. After all the boxes had been opened, each pattern was then shown in the center of the screen in a randomized order, and the patient should touch the box where they think each pattern was hidden. The PAL total errors adjusted comprised the number of errors committed by a patient plus an adjustment for the estimated number of errors the patient would have made on any stages that were not reached. Z score represents the standardized measure of how far an individual patient deviates from the study cohort average at baseline. A higher Z score indicated better performance. The mean change from baseline averaged across all the visits is reported.	Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).
Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score Time Frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).	Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Reaction Time (RTI) test assessed the cognitive domain of psychomotor speed (detecting and responding to a stimulus). Participants held down a button until a spot appeared in 1 of 5 circles on the screen. As soon as possible after the spot flashed up, the patient lifted their finger from the button and touched the circle in which the spot appeared. The RTI median 5-choice reaction time was the median duration between the onset of the stimulus and the release of the button. Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.	Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

AmgenTrials clinical trials website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2014

Primary Completion (Actual)

November 11, 2016

Study Completion (Actual)

November 11, 2016

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 4, 2014

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

December 15, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

20130385
2014-001976-75 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Dyslipidemia

Clinical Trials on Evolocumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations