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

2017년 12월 15일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

1974

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Alexandroupoli, 그리스, 68100
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      • Athens, 그리스, 14233
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      • Athens, 그리스, 11521
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      • Athens, 그리스, 14561
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      • Ioannina, 그리스, 45500
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      • Larissa, 그리스, 41110
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      • Piraeus, 그리스, 18536
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  • 남아프리카
      • Cape Town, 남아프리카, 7530
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      • Kempton Park, 남아프리카, 1619
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    • Gauteng
      • Centurion, Gauteng, 남아프리카, 0158
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      • Johannesburg, Gauteng, 남아프리카, 2196
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      • Johannesburg, Gauteng, 남아프리카, 1724
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      • Pretoria, Gauteng, 남아프리카, 0184
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      • Pretoria west, Gauteng, 남아프리카, 0183
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    • Western Cape
      • Paarl, Western Cape, 남아프리카, 7646
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      • Parow, Western Cape, 남아프리카, 7505
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      • Somerset West, Western Cape, 남아프리카, 7130
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      • Worcester, Western Cape, 남아프리카, 6850
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      • Arnhem, 네덜란드, 6815 AD
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      • Eindhoven, 네덜란드, 5623 EJ
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      • Hoorn, 네덜란드, 1625 HV
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      • Uden, 네덜란드, 5406 PT
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  • 노르웨이
      • Hamar, 노르웨이, 2317
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      • Lierskogen, 노르웨이, 3420
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      • Oslo, 노르웨이, 0450
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      • Aalborg, 덴마크, 9000
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      • Ballerup, 덴마크, 2750
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      • Hvidovre, 덴마크, 2650
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      • Køge, 덴마크, 4600
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  • 독일
      • Bad Krozingen, 독일, 79189
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      • Berlin, 독일, 10787
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      • Berlin, 독일, 13353
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      • Berlin, 독일, 12559
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      • Bochum, 독일, 44787
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      • Witten, 독일, 58455
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      • Wuppertal, 독일, 42117
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  • 라트비아
      • Daugavpils, 라트비아, 5417
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      • Kuldiga, 라트비아, LV-3301
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      • Liepaja, 라트비아, 3402
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      • Ogre, 라트비아, 5001
        • Research Site
      • Ogre, 라트비아, LV-5003
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      • Riga, 라트비아, 1012
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      • Riga, 라트비아, LV-1001
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  • 러시아 연방
      • Ekaterinburg, 러시아 연방, 620144
        • Research Site
      • Ivanovo, 러시아 연방, 153012
        • Research Site
      • Izhevsk, 러시아 연방, 426063
        • Research Site
      • Kemerovo, 러시아 연방, 650002
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      • Kemerovo, 러시아 연방, 650099
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      • Kirov, 러시아 연방, 610014
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      • Moscow, 러시아 연방, 121552
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      • Moscow, 러시아 연방, 117292
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      • Nizhniy Novgorod, 러시아 연방, 603076
        • Research Site
      • Novosibirsk, 러시아 연방, 630089
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      • Omsk, 러시아 연방, 644018
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      • Pushkin, 러시아 연방, 196601
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      • Saint Petersburg, 러시아 연방, 192242
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      • Saint Petersburg, 러시아 연방, 197022
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      • Saint-Petersburg, 러시아 연방, 199106
        • Research Site
      • Saratov, 러시아 연방, 410054
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      • St. Petersburg, 러시아 연방, 191015
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      • Tomsk, 러시아 연방, 634012
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  • 리투아니아
      • Vilnius, 리투아니아, 10323
        • Research Site
  • 말레이시아
      • Kuala Lumpur, 말레이시아, 59100
        • Research Site
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, 말레이시아, 56000
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  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35294
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    • Arizona
      • Glendale, Arizona, 미국, 85306
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    • California
      • Alhambra, California, 미국, 91801
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      • Harbor City, California, 미국, 90710
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      • Laguna Hills, California, 미국, 92653
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      • Long Beach, California, 미국, 90807
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      • Long Beach, California, 미국, 90822
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      • Oceanside, California, 미국, 92056
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      • Oxnard, California, 미국, 93030
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      • Roseville, California, 미국, 95661
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      • Sacramento, California, 미국, 95816
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      • San Pedro, California, 미국, 90732
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      • Tarzana, California, 미국, 91356
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      • Thousand Oaks, California, 미국, 91360
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    • Colorado
      • Aurora, Colorado, 미국, 80012
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      • Colorado Springs, Colorado, 미국, 80909
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      • Denver, Colorado, 미국, 80218
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    • Connecticut
      • Bridgeport, Connecticut, 미국, 06610
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    • Florida
      • Boynton Beach, Florida, 미국, 33472
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      • Crystal River, Florida, 미국, 34429
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      • Daytona Beach, Florida, 미국, 32117
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      • Deerfield Beach, Florida, 미국, 33442
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      • Fleming Island, Florida, 미국, 32003
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      • Hollywood, Florida, 미국, 33021
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      • Hollywood, Florida, 미국, 33024
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      • Jacksonville, Florida, 미국, 32216
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      • Miami, Florida, 미국, 33144
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      • Sarasota, Florida, 미국, 34232
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      • West Palm Beach, Florida, 미국, 33401
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    • Georgia
      • Atlanta, Georgia, 미국, 30342
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      • Suwanee, Georgia, 미국, 30024
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    • Idaho
      • Coeur d'Alene, Idaho, 미국, 83814
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    • Illinois
      • Addison, Illinois, 미국, 60101
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      • Belleville, Illinois, 미국, 62220
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      • Chicago, Illinois, 미국, 60616
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      • Jerseyville, Illinois, 미국, 62052
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    • Indiana
      • Hammond, Indiana, 미국, 46320
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    • Iowa
      • Waterloo, Iowa, 미국, 50702
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    • Kansas
      • Hutchinson, Kansas, 미국, 67502
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    • Kentucky
      • Lexington, Kentucky, 미국, 40503
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      • Owensboro, Kentucky, 미국, 42303
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    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70808
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      • Hammond, Louisiana, 미국, 70403
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      • Lafayette, Louisiana, 미국, 70508
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      • Metairie, Louisiana, 미국, 70006
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      • Monroe, Louisiana, 미국, 71201
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      • Slidell, Louisiana, 미국, 70458
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    • Maine
      • Biddeford, Maine, 미국, 04005
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    • Maryland
      • Salisbury, Maryland, 미국, 21804
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      • Towson, Maryland, 미국, 21204
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    • Massachusetts
      • Haverhill, Massachusetts, 미국, 01830
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      • Newton, Massachusetts, 미국, 02459
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    • Michigan
      • Ann Arbor, Michigan, 미국, 48106
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      • Grandville, Michigan, 미국, 49418
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      • Lansing, Michigan, 미국, 48912
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      • Muskegon, Michigan, 미국, 49444
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    • Minnesota
      • Saint Paul, Minnesota, 미국, 55102
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      • Jefferson City, Missouri, 미국, 65109
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      • Saint Louis, Missouri, 미국, 63117
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      • Saint Louis, Missouri, 미국, 63128
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      • Great Falls, Montana, 미국, 59405
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      • Voorhees, New Jersey, 미국, 08043
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      • Pawtucket, Rhode Island, 미국, 02860
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      • Jackson, Tennessee, 미국, 38305
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      • Hopewell, Virginia, 미국, 23860
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      • Richmond, Virginia, 미국, 23294
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      • Richmond, Virginia, 미국, 23219
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      • Suffolk, Virginia, 미국, 23435
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    • Wisconsin
      • Green Bay, Wisconsin, 미국, 54301
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  • 벨기에
      • Aalst, 벨기에, 9300
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      • Bonheiden, 벨기에, 2820
        • Research Site
      • Brussels, 벨기에, 1070
        • Research Site
      • Brussels, 벨기에, 1020
        • Research Site
      • Gozee, 벨기에, 6534
        • Research Site
      • Ieper, 벨기에, 8900
        • Research Site
      • La Louvière, 벨기에, 7100
        • Research Site
      • Liege, 벨기에, 4000
        • Research Site
      • Liège, 벨기에, 4000
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  • 스웨덴
      • Helsingborg, 스웨덴, 251 87
        • Research Site
      • Linköping, 스웨덴, 581 85
        • Research Site
      • Lund, 스웨덴, 222 21
        • Research Site
      • Stockholm, 스웨덴, 171 76
        • Research Site
      • Stockholm, 스웨덴, 111 35
        • Research Site
      • Uddevalla, 스웨덴, 451 50
        • Research Site
      • Västerås, 스웨덴, 721 89
        • Research Site
  • 스페인
      • Madrid, 스페인, 28034
        • Research Site
    • Aragón
      • Zaragoza, Aragón, 스페인, 50009
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    • Cataluña
      • L'Hospitalet de Llobregat, Cataluña, 스페인, 08907
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, 스페인, 46010
        • Research Site
    • Galicia
      • Santiago de Compostela, Galicia, 스페인, 15706
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      • Vigo, Galicia, 스페인, 36200
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      • Galdakao, País Vasco, 스페인, 48960
        • Research Site
  • 슬로바키아
      • Bardejov, 슬로바키아, 085 01
        • Research Site
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      • Lucenec, 슬로바키아, 984 01
        • Research Site
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      • Nove Zamky, 슬로바키아, 940 01
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      • Rimavska Sobota, 슬로바키아, 979 01
        • Research Site
      • Roznava, 슬로바키아, 048 01
        • Research Site
      • Snina, 슬로바키아, 069 01
        • Research Site
      • Svidnik, 슬로바키아, 08901
        • Research Site
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      • Trnava, 슬로바키아, 917 01
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  • 에스토니아
      • Paide, 에스토니아, 72713
        • Research Site
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      • Tallinn, 에스토니아, 10128
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  • 영국
      • Belfast, 영국, BT7 2EB
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      • Bournemouth, 영국, BH7 7DW
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      • Chesterfield, 영국, S40 4AA
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      • Chippenham, 영국, SN15 2SB
        • Research Site
      • Chorley, 영국, PR7 7NA
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      • Doncaster, 영국, DN9 1EP
        • Research Site
      • Glasgow, 영국, G20 0SP
        • Research Site
      • Glasgow, 영국, G45 9AW
        • Research Site
      • Hexham, 영국, NE46 1QJ
        • Research Site
      • Leicester, 영국, LE3 9QP
        • Research Site
      • Liverpool, 영국, L22 0LG
        • Research Site
      • Liverpool, 영국, L9 7AL
        • Research Site
      • London, 영국, EC1M 6BQ
        • Research Site
      • London, 영국, W2 1LA
        • Research Site
      • Manchester, 영국, M15 6SX
        • Research Site
      • Manchester, 영국, M23 9LT
        • Research Site
      • Newport, 영국, PO30 5TG
        • Research Site
      • Nuneaton, 영국, CV10 7DJ
        • Research Site
      • Reading, 영국, RG2 0TG
        • Research Site
      • Sandbach, 영국, CW11 1EQ
        • Research Site
      • Sheffield, 영국, S5 7AU
        • Research Site
      • West Bromwich, 영국, B71 4HJ
        • Research Site
      • Whitby, 영국, YO21 1SD
        • Research Site
      • Worcester, 영국, WR5 1DD
        • Research Site
  • 이탈리아
      • Pavia, 이탈리아, 27100
        • Research Site
  • 일본
    • Aichi
      • Ichinomiya-shi, Aichi, 일본, 491-8551
        • Research Site
      • Kasugai-shi, Aichi, 일본, 487-0031
        • Research Site
      • Nagoya-shi, Aichi, 일본, 460-0001
        • Research Site
      • Nagoya-shi, Aichi, 일본, 451-8511
        • Research Site
      • Nagoya-shi, Aichi, 일본, 457-8511
        • Research Site
      • Toyohashi-shi, Aichi, 일본, 440-8510
        • Research Site
    • Chiba
      • Matsudo-shi, Chiba, 일본, 271-0077
        • Research Site
    • Ehime
      • Saijo-shi, Ehime, 일본, 793-0030
        • Research Site
    • Fukuoka
      • Chikushi-gun, Fukuoka, 일본, 811-1244
        • Research Site
      • Fukuoka-shi, Fukuoka, 일본, 814-0180
        • Research Site
      • Fukuoka-shi, Fukuoka, 일본, 814-8522
        • Research Site
      • Itoshima-shi, Fukuoka, 일본, 819-1104
        • Research Site
    • Hokkaido
      • Sapporo-shi, Hokkaido, 일본, 060-0031
        • Research Site
    • Hyogo
      • Himeji-shi, Hyogo, 일본, 672-8043
        • Research Site
    • Ibaraki
      • Toride-shi, Ibaraki, 일본, 302-0022
        • Research Site
      • Tsukuba-city, Ibaraki, 일본, 305-8558
        • Research Site
    • Kyoto
      • Kyoto-shi, Kyoto, 일본, 615-0035
        • Research Site
    • Okinawa
      • Okinawa-shi, Okinawa, 일본, 904-8585
        • Research Site
      • Shimajiri-gun, Okinawa, 일본, 901-0493
        • Research Site
      • Urasoe-shi, Okinawa, 일본, 901-2132
        • Research Site
    • Osaka
      • Osaka-shi, Osaka, 일본, 530-0001
        • Research Site
      • Osaka-shi, Osaka, 일본, 543-0035
        • Research Site
    • Saga
      • Saga-shi, Saga, 일본, 840-8571
        • Research Site
      • Saga-shi, Saga, 일본, 849-0917
        • Research Site
    • Saitama
      • Kawaguchi-shi, Saitama, 일본, 332-8558
        • Research Site
    • Tokushima
      • Komatsushima-shi, Tokushima, 일본, 773-8502
        • Research Site
    • Tokyo
      • Chuo-ku, Tokyo, 일본, 103-0027
        • Research Site
  • 체코
      • Beroun, 체코, 266 01
        • Research Site
      • Bilovec, 체코, 743 01
        • Research Site
      • Brandys nad Labem, 체코, 250 01
        • Research Site
      • Brno, 체코, 602 00
        • Research Site
      • Brno, 체코, 636 00
        • Research Site
      • Brno, 체코, 638 00
        • Research Site
      • Chomutov, 체코, 430 02
        • Research Site
      • Havlickuv Brod, 체코, 580 22
        • Research Site
      • Hodonin, 체코, 695 01
        • Research Site
      • Klatovy IV, 체코, 339 01
        • Research Site
      • Liberec, 체코, 460 63
        • Research Site
      • Litomysl, 체코, 570 14
        • Research Site
      • Mohelnice, 체코, 789 85
        • Research Site
      • Olomouc, 체코, 779 00
        • Research Site
      • Ostrava - Vitkovice, 체코, 703 00
        • Research Site
      • Pardubice, 체코, 530 02
        • Research Site
      • Praha 10, 체코, 101 00
        • Research Site
      • Praha 2, 체코, 128 08
        • Research Site
      • Praha 3, 체코, 130 00
        • Research Site
      • Praha 4, 체코, 140 21
        • Research Site
      • Praha 5 - Smichov, 체코, 150 00
        • Research Site
      • Prerov, 체코, 750 02
        • Research Site
      • Uherske Hradiste, 체코, 686 01
        • Research Site
  • 칠면조
      • Adana, 칠면조, 01330
        • Research Site
      • Ankara, 칠면조, 06100
        • Research Site
      • Gaziantep, 칠면조, 27310
        • Research Site
      • Istanbul, 칠면조, 34096
        • Research Site
      • Istanbul, 칠면조, 34865
        • Research Site
      • Izmir, 칠면조, 35100
        • Research Site
      • Kocaeli, 칠면조, 41380
        • Research Site
  • 캐나다
      • Quebec, 캐나다, G1V 4M6
        • Research Site
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, 캐나다, A1B 3V6
        • Research Site
    • Ontario
      • London, Ontario, 캐나다, N6C 0A7
        • Research Site
      • Newmarket, Ontario, 캐나다, L3Y 5G8
        • Research Site
      • Newmarket, Ontario, 캐나다, L3Y 8C3
        • Research Site
      • Peterborough, Ontario, 캐나다, K9J 0B2
        • Research Site
      • Sarnia, Ontario, 캐나다, N7T 4X3
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, 캐나다, G7H 7K9
        • Research Site
      • Gatineau, Quebec, 캐나다, J8Y 6S8
        • Research Site
      • Pointe-Claire, Quebec, 캐나다, H9R 3J1
        • Research Site
      • St Jean sur Richelieu, Quebec, 캐나다, J3A 1C3
        • Research Site
      • St-Jérôme, Quebec, 캐나다, J7Z 5T3
        • Research Site
  • 포르투갈
      • Almada, 포르투갈, 2801-951
        • Research Site
      • Carnaxide, 포르투갈, 2790-134
        • Research Site
      • Coimbra, 포르투갈, 3000-075
        • Research Site
      • Covilha, 포르투갈, 6200-251
        • Research Site
  • 폴란드
      • Gdansk, 폴란드, 80-952
        • Research Site
      • Gdynia, 폴란드, 81-384
        • Research Site
      • Gdynia, 폴란드, 81-402
        • Research Site
      • Katowice, 폴란드, 40-040
        • Research Site
      • Katowice, 폴란드, 40-084
        • Research Site
      • Katowice, 폴란드, 40-018
        • Research Site
      • Kielce, 폴란드, 25-020
        • Research Site
      • Krakow, 폴란드, 31-216
        • Research Site
      • Krakow, 폴란드, 32-082
        • Research Site
      • Lodz, 폴란드, 91-347
        • Research Site
      • Lodz, 폴란드, 90-368
        • Research Site
      • Lublin, 폴란드, 20-857
        • Research Site
      • Olsztyn, 폴란드, 10-010
        • Research Site
      • Poznan, 폴란드, 60-702
        • Research Site
      • Pulawy, 폴란드, 24-100
        • Research Site
      • Ruda Slaska, 폴란드, 41-709
        • Research Site
      • Staszow, 폴란드, 28-200
        • Research Site
      • Swidnik, 폴란드, 21-040
        • Research Site
      • Tarnow, 폴란드, 33-100
        • Research Site
      • Torun, 폴란드, 87-100
        • Research Site
      • Warszawa, 폴란드, 01-192
        • Research Site
      • Warszawa, 폴란드, 02-507
        • Research Site
      • Warszawa, 폴란드, 04-730
        • Research Site
      • Wloclawek, 폴란드, 87-800
        • Research Site
      • Wroclaw, 폴란드, 50-088
        • Research Site
      • Wroclaw, 폴란드, 50-349
        • Research Site
      • Wroclaw, 폴란드, 51-685
        • Research Site
      • Zamosc, 폴란드, 22-400
        • Research Site
  • 프랑스
      • Besançon Cedex, 프랑스, 25030
        • Research Site
      • Le Coudray, 프랑스, 28630
        • Research Site
      • Montepellier Cedex, 프랑스, 34295
        • Research Site
      • Nantes Cedex 1, 프랑스, 44093
        • Research Site
      • Paris, 프랑스, 75013
        • Research Site
      • Pessac Cedex, 프랑스, 33604
        • Research Site
      • Toulouse Cedex 9, 프랑스, 31059
        • Research Site
  • 핀란드
      • Helsinki, 핀란드, 00290
        • Research Site
      • Helsinki, 핀란드, 00180
        • Research Site
      • Jyväskylä, 핀란드, 40100
        • Research Site
      • Kuopio, 핀란드, 70100
        • Research Site
      • OYS, 핀란드, 90029
        • Research Site
      • Oulu, 핀란드, 90100
        • Research Site
      • Tampere, 핀란드, 33100
        • Research Site
      • Turku, 핀란드, 20100
        • Research Site
  • 헝가리
      • Bekescsaba, 헝가리, 5600
        • Research Site
      • Berettyoujfalu, 헝가리, 4100
        • Research Site
      • Budapest, 헝가리, 1036
        • Research Site
      • Nyiregyhaza, 헝가리, 4400
        • Research Site
      • Pecs, 헝가리, 7624
        • Research Site
      • Szeged, 헝가리, 6725
        • Research Site
      • Szekszard, 헝가리, 7100
        • Research Site
      • Szikszo, 헝가리, 3800
        • Research Site
      • Zalaegerszeg, 헝가리, 8900
        • Research Site
  • 호주
    • Australian Capital Territory
      • Woden, Australian Capital Territory, 호주, 2605
        • Research Site
    • Queensland
      • Auchenflower, Queensland, 호주, 4066
        • Research Site
    • South Australia
      • Adelaide, South Australia, 호주, 5000
        • Research Site
      • Ashford, South Australia, 호주, 5035
        • Research Site
      • Fullarton, South Australia, 호주, 5063
        • Research Site
    • Tasmania
      • Hobart, Tasmania, 호주, 7000
        • Research Site
    • Victoria
      • Box Hill, Victoria, 호주, 3128
        • Research Site
      • Epping, Victoria, 호주, 3076
        • Research Site
      • Geelong, Victoria, 호주, 3220
        • Research Site
  • 홍콩
      • Hong Kong, 홍콩
        • Research Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Randomized into Study 20110118 (FOURIER; NCT01764633)

Exclusion Criteria:

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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.
의약품: 위약
스프링 기반의 미리 채워진 1.0mL 자가주사기/펜을 사용하여 피하 투여.
의약품: 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.
실험적: 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.
생물학적: 에볼로쿠맙
스프링 기반의 미리 채워진 1.0mL 자가주사기/펜을 사용하여 피하 투여.
다른 이름들:
  • 레파타
  • AMG 145
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score
기간: 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).

2차 결과 측정

결과 측정
측정값 설명
기간
Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score
기간: 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
기간: 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
기간: 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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Amgen

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 9월 10일

기본 완료 (실제)

2016년 11월 11일

연구 완료 (실제)

2016년 11월 11일

연구 등록 날짜

최초 제출

2014년 7월 31일

QC 기준을 충족하는 최초 제출

2014년 7월 31일

처음 게시됨 (추정)

2014년 8월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 1월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 12월 15일

마지막으로 확인됨

2017년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 20130385
  • 2014-001976-75 (EudraCT 번호)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

에볼로쿠맙에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Zambia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다