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

15 dicembre 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1974

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Randomized into Study 20110118 (FOURIER; NCT01764633)

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: 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.
Droga: Placebo
Somministrato per via sottocutanea utilizzando un autoiniettore/penna preriempita a molla da 1,0 ml.
Droga: 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.
Sperimentale: 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.
Biologico: Evolocumab
Somministrato per via sottocutanea utilizzando un autoiniettore/penna preriempita a molla da 1,0 ml.
Altri nomi:
  • Repatha
  • AMG 145
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Amgen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 settembre 2014

Completamento primario (Effettivo)

11 novembre 2016

Completamento dello studio (Effettivo)

11 novembre 2016

Date di iscrizione allo studio

Primo inviato

31 luglio 2014

Primo inviato che soddisfa i criteri di controllo qualità

31 luglio 2014

Primo Inserito (Stima)

4 agosto 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 gennaio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 dicembre 2017

Ultimo verificato

1 dicembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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