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

15. december 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1974

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Randomized into Study 20110118 (FOURIER; NCT01764633)

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 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.
Medicin: Placebo
Indgivet subkutant ved hjælp af en fjederbaseret forfyldt 1,0 ml autoinjektor/pen.
Medicin: 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.
Eksperimentel: 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.
Biologisk: Evolocumab
Indgivet subkutant ved hjælp af en fjederbaseret forfyldt 1,0 ml autoinjektor/pen.
Andre navne:
  • Repatha
  • AMG 145
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. september 2014

Primær færdiggørelse (Faktiske)

11. november 2016

Studieafslutning (Faktiske)

11. november 2016

Datoer for studieregistrering

Først indsendt

31. juli 2014

Først indsendt, der opfyldte QC-kriterier

31. juli 2014

Først opslået (Skøn)

4. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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