DyslipidemiaPhase 3EBBINGHAUSNCT02207634

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

A Phase 3 study testing Evolocumab and Background Statin Therapy in people with Dyslipidemia, run by Amgen at 416 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Dyslipidemia
What is being tested?: Evolocumab and Background Statin Therapy
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,974 participants
Where: 416 sitesin 30 countries
Study dates: 10 Sep 2014to 11 Nov 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Randomized into Study 20110118 (FOURIER; NCT01764633)

Who cannot join

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

Trial locations and contacts

416 sites in 30 countries.

Country

City, postcode or hospital

416 sites in 30 countries

United States134 sites

Research Site
Addison, Illinois, 60101
Research Site
Alhambra, California, 91801
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Ann Arbor, Michigan, 48106
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Atlanta, Georgia, 30342
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Augusta, Georgia, 30909
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Aurora, Colorado, 80012
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Austin, Texas, 78758
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Banning, California, 92220
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Baton Rouge, Louisiana, 70808
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Belleville, Illinois, 62220
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Bend, Oregon, 97701
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Biddeford, Maine, 04005
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Birmingham, Alabama, 35294
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Boynton Beach, Florida, 33472
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Bridgeport, Connecticut, 06610
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Brooklyn, New York, 11206
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Buffalo, New York, 14215
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Burke, Virginia, 22015
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Calabash, North Carolina, 28467
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Camp Hill, Pennsylvania, 17011
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Canton, Ohio, 44708
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Chambersburg, Pennsylvania, 17201
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Chicago, Illinois, 60616
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Cincinnati, Ohio, 45219
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Coeur d'Alene, Idaho, 83814
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Colorado Springs, Colorado, 80909
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Columbus, Ohio, 43201
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Columbus, Ohio, 43215
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Cortlandt Manor, New York, 10567
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Crystal River, Florida, 34429
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Dallas, Texas, 75216
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Dayton, Ohio, 45414
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Daytona Beach, Florida, 32117
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Deerfield Beach, Florida, 33442
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Denver, Colorado, 80218
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Falls Church, Virginia, 22042
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Feasterville, Pennsylvania, 19053
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Fleming Island, Florida, 32003
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Fort Mill, South Carolina, 29707
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Gainesville, Georgia, 30501
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Glendale, Arizona, 85306
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Grand Forks, North Dakota, 58201
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Grandville, Michigan, 49418
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Great Falls, Montana, 59405
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Green Bay, Wisconsin, 54301
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Hammond, Indiana, 46320
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Hammond, Louisiana, 70403
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Harbor City, California, 90710
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Haverhill, Massachusetts, 01830
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Hickory, North Carolina, 28601
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Hickory, North Carolina, 28602
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Hollywood, Florida, 33021
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Hollywood, Florida, 33024
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Hopewell, Virginia, 23860
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Houston, Texas, 77025
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Houston, Texas, 77030
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Huntsville, Alabama, 35801
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Hutchinson, Kansas, 67502
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32216
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Jefferson City, Missouri, 65109
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Jerseyville, Illinois, 62052
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Kalispell, Montana, 59901
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Lafayette, Louisiana, 70508
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Laguna Hills, California, 92653
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Lansing, Michigan, 48912
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Lexington, Kentucky, 40503
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Long Beach, California, 90807
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Long Beach, California, 90822
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Metairie, Louisiana, 70006
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Miami, Florida, 33144
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Mobile, Alabama, 36608
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Moncks Corner, South Carolina, 29461
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Monroe, Louisiana, 71201
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Mooresville, North Carolina, 28117
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Mt. Pleasant, South Carolina, 29464
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Muskegon, Michigan, 49444
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Nashville, Tennessee, 37203
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New Hyde Park, New York, 11042
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New Windsor, New York, 12553
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Newton, Massachusetts, 02459
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North Myrtle Beach, South Carolina, 29582
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Oceanside, California, 92056
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Owensboro, Kentucky, 42303
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Oxnard, California, 93030
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Palm Harbor, Florida, 34684
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Palm Springs, California, 92262
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Pawtucket, Rhode Island, 02860
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Pembroke Pines, Florida, 33025
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Philadelphia, Pennsylvania, 19152
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Phoenix, Arizona, 85018
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Pittsburgh, Pennsylvania, 15206
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Plano, Texas, 75024
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Ponte Vedra, Florida, 32081
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Portland, Oregon, 97225
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Portland, Oregon, 97239
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Pryor, Oklahoma, 74362
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Raleigh, North Carolina, 27609
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Rapid City, South Dakota, 57701
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Richmond, Virginia, 23219
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Richmond, Virginia, 23294
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Rochester, New York, 14609
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Roseville, California, 95661
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Sacramento, California, 95816
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Saint Paul, Minnesota, 55102
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Salisbury, Maryland, 21804
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San Pedro, California, 90732
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Sarasota, Florida, 34232
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Savannah, Georgia, 31406
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Seattle, Washington, 98195
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Slidell, Louisiana, 70458
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Springfield, Ohio, 45505
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St Louis, Missouri, 63117
Research Site
St Louis, Missouri, 63128
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St. Petersburg, Florida, 33713
Research Site
Suffolk, Virginia, 23435
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Suwanee, Georgia, 30024
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Tabor City, North Carolina, 28463
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Tampa, Florida, 33614
Research Site
Tarzana, California, 91356
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Thousand Oaks, California, 91360
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Toledo, Ohio, 43615
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Towson, Maryland, 21204
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Troy, New York, 12180
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Tullahoma, Tennessee, 37388
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Voorhees Township, New Jersey, 08043
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Waterloo, Iowa, 50702
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West Jordan, Utah, 84088
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West Palm Beach, Florida, 33401
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West Seneca, New York, 14224
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Westwood, New Jersey, 07675
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Wichita Falls, Texas, 76301
Research Site
Williamsville, New York, 14221
Research Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Poland28 sites

Research Site
Gdansk, 80-952
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Gdynia, 81-384
Research Site
Gdynia, 81-402
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Katowice, 40-018
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Katowice, 40-040
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Katowice, 40-084
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Kielce, 25-020
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Krakow, 31-216
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Krakow, 32-082
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Lodz, 90-368
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Lodz, 91-347
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Lublin, 20-857
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Olsztyn, 10-010
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Poznan, 60-702
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Puławy, 24-100
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Ruda Śląska, 41-709
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Staszów, 28-200
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Świdnik, 21-040
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Tarnów, 33-100
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Torun, 87-100
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Warsaw, 01-192
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Warsaw, 02-507
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Warsaw, 04-730
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Włocławek, 87-800
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Wroclaw, 50-088
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Wroclaw, 50-349
Research Site
Wroclaw, 51-685
Research Site
Zamość, 22-400

Other trials in Poland

Japan27 sites

Research Site
Chikushi-gun, Fukuoka, 811-1244
Research Site
Chuo-ku, Tokyo, 103-0027
Research Site
Fukuoka, Fukuoka, 814-0180
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Fukuoka, Fukuoka, 814-8522
Research Site
Himeji-shi, Hyōgo, 672-8043
Research Site
Ichinomiya-shi, Aichi-ken, 491-8551
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Itoshima-shi, Fukuoka, 819-1104
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Kasugai-shi, Aichi-ken, 487-0031
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Kawaguchi-shi, Saitama, 332-8558
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Komatsushima-shi, Tokushima, 773-8502
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Kyoto, Kyoto, 615-0035
Research Site
Matsudo-shi, Chiba, 271-0077
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Nagoya, Aichi-ken, 451-8511
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Nagoya, Aichi-ken, 457-8511
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Nagoya, Aichi-ken, 460-0001
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Okinawa-shi, Okinawa, 904-8585
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Osaka, Osaka, 530-0001
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Osaka, Osaka, 543-0035
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Saga, Saga-ken, 840-8571
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Saga, Saga-ken, 849-0917
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Saijo-shi, Ehime, 793-0030
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Sapporo, Hokkaido, 060-0031
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Shimajiri-gun, Okinawa, 901-0493
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Toride-shi, Ibaraki, 302-0022
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Toyohashi, Aichi-ken, 440-8510
Research Site
Tsukuba, Ibaraki, 305-8558
Research Site
Urasoe-shi, Okinawa, 901-2132

Other trials in Japan

United Kingdom27 sites

Research Site
Belfast, BT7 2EB
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Birmingham, B15 2SQ
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Birmingham, B18 7QH
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Bournemouth, BH7 7DW
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Cardiff, CF14 5GJ
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Chesterfield, S40 4AA
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Chippenham, SN15 2SB
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Chorley, PR7 7NA
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Doncaster, DN9 1EP
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Glasgow, G20 0SP
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Glasgow, G45 9AW
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Hexham, NE46 1QJ
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Leicester, LE3 9QP
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Liverpool, L22 0LG
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Liverpool, L9 7AL
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London, EC1M 6BQ
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London, W2 1LA
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Manchester, M15 6SX
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Manchester, M23 9LT
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Newport, PO30 5TG
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Nuneaton, CV10 7DJ
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Reading, RG2 0TG
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Sandbach, CW11 1EQ
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Sheffield, S5 7AU
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West Bromwich, B71 4HJ
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Whitby, YO21 1SD
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Worcester, WR5 1DD

Other trials in United Kingdom

Czechia23 sites

Research Site
Beroun, 266 01
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Bílovec, 743 01
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Brandýs nad Labem, 250 01
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Brno, 602 00
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Brno, 636 00
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Brno, 638 00
Research Site
Chomutov, 430 02
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Havlíčkův Brod, 580 22
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Hodonín, 695 01
Research Site
Klatovy IV, 339 01
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Liberec, 460 63
Research Site
Litomyšl, 570 14
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Mohelnice, 789 85
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Olomouc, 779 00
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Ostrava - Vitkovice, 703 00
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Pardubice, 530 02
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Prague, 101 00
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Prague, 128 08
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Prague, 130 00
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Prague, 140 21
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Praha 5 - Smichov, 150 00
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Přerov, 750 02
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Uherské Hradiště, 686 01

Other trials in Czechia

Russia18 sites

Research Site
Ivanovo, 153012
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Izhevsk, 426063
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Kemerovo, 650002
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Kemerovo, 650099
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Kirov, 610014
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Moscow, 117292
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Moscow, 121552
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Nizhny Novgorod, 603076
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Novosibirsk, 630089
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Omsk, 644018
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Pushkin, 196601
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Saint Petersburg, 191015
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Saint Petersburg, 192242
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Saint Petersburg, 197022
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Saint Petersburg, 199106
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Saratov, 410054
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Tomsk, 634012
Research Site
Yekaterinburg, 620144

Other trials in Russia

Germany14 sites

Research Site
Bad Krozingen, 79189
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Berlin, 10787
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Berlin, 12559
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Berlin, 13353
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Bochum, 44787
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Cologne, 50937
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Dresden, 01307
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Frankfurt am Main, 60596
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Hamburg, 20246
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Hanover, 30159
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Leipzig, 04103
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Stuttgart, 70376
Research Site
Witten, 58455
Research Site
Wuppertal, 42117

Other trials in Germany

Canada12 sites

Research Site
Chicoutimi, Quebec, G7H 7K9
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Gatineau, Quebec, J8Y 6S8
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London, Ontario, N6C 0A7
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Newmarket, Ontario, L3Y 5G8
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Newmarket, Ontario, L3Y 8C3
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Peterborough, Ontario, K9J 0B2
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Pointe-Claire, Quebec, H9R 3J1
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Québec, Quebec, G1V 4M6
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Saint-Jean-sur-Richelieu, Quebec, J3A 1C3
Research Site
Saint-Jérôme, Quebec, J7Z 5T3
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6

Other trials in Canada

Slovakia12 sites

Research Site
Bardejov, 085 01
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Brezno, 977 42
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Košice, 040 22
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Lučenec, 984 01
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Moldava nad Bodvou, 045 01
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Nové Zámky, 940 01
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Rimavská Sobota, 979 01
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Rožňava, 048 01
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Snina, 069 01
Research Site
Svidník, 08901
Research Site
Trenčín, 911 01
Research Site
Trnava, 917 01

Other trials in Slovakia

South Africa11 sites

Research Site
Cape Town, 7530
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Centurion, Gauteng, 0158
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Johannesburg, Gauteng, 1724
Research Site
Johannesburg, Gauteng, 2196
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Kempton Park, 1619
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Paarl, Western Cape, 7646
Research Site
Parow, Western Cape, 7505
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Pretoria, Gauteng, 0184
Research Site
Pretoria West, Gauteng, 0183
Research Site
Somerset West, Western Cape, 7130
Research Site
Worcester, Western Cape, 6850

Other trials in South Africa

Australia9 sites

Research Site
Adelaide, South Australia, 5000
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Ashford, South Australia, 5035
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Auchenflower, Queensland, 4066
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Box Hill, Victoria, 3128
Research Site
Epping, Victoria, 3076
Research Site
Fullarton, South Australia, 5063
Research Site
Geelong, Victoria, 3220
Research Site
Hobart, Tasmania, 7000
Research Site
Woden, Australian Capital Territory, 2605

Other trials in Australia

Hungary9 sites

Research Site
Békéscsaba, 5600
Research Site
Berettyóújfalu, 4100
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Budapest, 1036
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Nyíregyháza, 4400
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Pécs, 7624
Research Site
Szeged, 6725
Research Site
Szekszárd, 7100
Research Site
Szikszó, 3800
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

Belgium8 sites

Research Site
Aalst, 9300
Research Site
Bonheiden, 2820
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Brussels, 1020
Research Site
Brussels, 1070
Research Site
Gozée, 6534
Research Site
Ieper, 8900
Research Site
La Louvière, 7100
Research Site
Liège, 4000

Other trials in Belgium

Finland8 sites

Research Site
Helsinki, 00180
Research Site
Helsinki, 00290
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Jyväskylä, 40100
Research Site
Kuopio, 70100
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Oulu, 90100
Research Site
OYS, 90029
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Tampere, 33100
Research Site
Turku, 20100

Other trials in Finland

Denmark7 sites

Research Site
Aalborg, 9000
Research Site
Ballerup Municipality, 2750
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Esbjerg, 6700
Research Site
Hvidovre, 2650
Research Site
København S, 2300
Research Site
Køge, 4600
Research Site
Vejle, 7100

Other trials in Denmark

France7 sites

Research Site
Besançon, 25030
Research Site
Le Coudray, 28630
Research Site
Montepellier Cedex, 34295
Research Site
Nantes, 44093
Research Site
Paris, 75013
Research Site
Pessac, 33604
Research Site
Toulouse, 31059

Other trials in France

Greece7 sites

Research Site
Alexandroupoli, 68100
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Athens, 11521
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Athens, 14233
Research Site
Athens, 14561
Research Site
Ioannina, 45500
Research Site
Larissa, 41110
Research Site
Piraeus, 18536

Other trials in Greece

Latvia7 sites

Research Site
Daugavpils, 5417
Research Site
Kuldīga, LV-3301
Research Site
Liepāja, 3402
Research Site
Ogre, 5001
Research Site
Ogre, LV-5003
Research Site
Riga, 1012
Research Site
Riga, LV-1001

Other trials in Latvia

Norway7 sites

Research Site
Ålesund, 6003
Research Site
Hamar, 2317
Research Site
Lierskogen, 3420
Research Site
Oslo, 0450
Research Site
Skedsmokorset, 2020
Research Site
Skien, 3710
Research Site
Stavanger, 4005

Other trials in Norway

Spain7 sites

Research Site
Galdakao, Basque Country, 48960
Research Site
L'Hospitalet de Llobregat, Catalonia, 08907
Research Site
Madrid, 28034
Research Site
Santiago de Compostela, Galicia, 15706
Research Site
Valencia, Valencia, 46010
Research Site
Vigo, Galicia, 36200
Research Site
Zaragoza, Aragon, 50009

Other trials in Spain

Sweden7 sites

Research Site
Helsingborg, 251 87
Research Site
Linköping, 581 85
Research Site
Lund, 222 21
Research Site
Stockholm, 111 35
Research Site
Stockholm, 171 76
Research Site
Uddevalla, 451 50
Research Site
Västerås, 721 89

Other trials in Sweden

Turkey (Türkiye)7 sites

Research Site
Adana, 01330
Research Site
Ankara, 06100
Research Site
Gaziantep, 27310
Research Site
Istanbul, 34096
Research Site
Istanbul, 34865
Research Site
Izmir, 35100
Research Site
Kocaeli, 41380

Other trials in Turkey (Türkiye)

Netherlands5 sites

Research Site
Arnhem, 6815 AD
Research Site
Ede, 6716 RP
Research Site
Eindhoven, 5623 EJ
Research Site
Hoorn, 1625 HV
Research Site
Uden, 5406 PT

Other trials in Netherlands

Estonia4 sites

Research Site
Paide, 72713
Research Site
Tallinn, 10128
Research Site
Tallinn, 10138
Research Site
Tallinn, 13419

Other trials in Estonia

Portugal4 sites

Research Site
Almada, 2801-951
Research Site
Carnaxide, 2790-134
Research Site
Coimbra, 3000-075
Research Site
Covilha, 6200-251

Other trials in Portugal

Malaysia2 sites

Research Site
Kuala Lumpur, Kuala Lumpur, 56000
Research Site
Kuala Lumpur, 59100

Other trials in Malaysia

New Zealand2 sites

Research Site
Christchurch, 8011
Research Site
Tauranga, 3143

Other trials in New Zealand

Hong Kong1 site

Research Site
Hong Kong

Other trials in Hong Kong

Italy1 site

Research Site
Pavia, 27100

Other trials in Italy

Lithuania1 site

Research Site
Vilnius, 10323

Other trials in Lithuania

About this study

Official title: 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

Read the detailed description

Participants who were enrolled in study 20110118 (FOURIER; NCT01764633) at select sites in select countries (selected based on study start-up timelines) were invited to participate in this cognitive function study, 20130385. There was no separate randomization for Study 20130385; data were analyzed according to Study 20110118 randomized treatment arm.

Conditions: Dyslipidemia
Being tested: Evolocumab, Placebo, Background Statin Therapy
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Medical subject headings: Dyslipidemias, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EvolocumabBiological
Also called AMG 145, Repatha
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
PlaceboDrug
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Background Statin TherapyDrug
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.

Study groups in NCT02207634
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: Placebo; Drug: Background Statin Therapy
Evolocumab	Experimental	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. Receives: Biological: Evolocumab; Drug: Background Statin Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score
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.
Measured: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201411 Nov 2016

First posted4 Aug 2014 (estimated)
Study start10 Sep 2014
Primary completion11 Nov 2016
Study completion11 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,974 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02207634
Sponsor's protocol ID: 20130385
Other IDs: 2014-001976-75, 2014
Acronym: EBBINGHAUS
Status last verified: Dec 2017
First submitted: 31 Jul 2014
Last updated: 16 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Giugliano RP, Mach F, Zavitz K, Kurtz C, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Design and rationale of the EBBINGHAUS trial: A phase 3, 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 cognitive study of patients enrolled in the FOURIER trial. Clin Cardiol. 2017 Feb;40(2):59-65. doi: 10.1002/clc.22678. Epub 2017 Feb 16.
PubMed 28207168
Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med. 2017 Aug 17;377(7):633-643. doi: 10.1056/NEJMoa1701131.
PubMed 28813214
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
PubMed 33078867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02207634
Acronym / sponsor ID: EBBINGHAUS / 20130385
Conditions: Dyslipidemia
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,974 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 10 Sep 2014 (actual)
Primary completion: 11 Nov 2016 (actual)
Study completion: 11 Nov 2016 (actual)
First posted: 4 Aug 2014 (estimated)
Results: Posted 16 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo, Drug: Background Statin TherapyParticipants 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.
Evolocumab	Experimental	Biological: Evolocumab, Drug: Background Statin TherapyParticipants 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.

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Randomized into Study 20110118 (FOURIER; NCT01764633)

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EvolocumabAlso: AMG 145, RepathaAdministered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.	Biological	Evolocumab
PlaceboAdministered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.	Drug	Placebo
Background Statin TherapyParticipants 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.	Drug	Evolocumab, Placebo

Primary outcome

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

3 secondary outcomes

Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score
Time frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).
Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score
Time frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).
Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score
Time frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).

Results and safety

Results posted to the registry on 16 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	990	968
Evolocumab	984	953

Primary outcome: Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score

Time frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).. Least squares mean (95% Confidence Interval). Unit: Z score

Measure	Placebo n = 616	Evolocumab n = 586
Value	0.1206 (0.0535 to 0.1877)	0.1134 (0.0449 to 0.1820)

Placebo vs Evolocumab: Treatment Difference: 0.0072 (95% CI -0.0664 to 0.0808)

Population analysed: All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure. Cognitive function assessments after an on-study stroke event were excluded from the analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study drug to the end of study. The median duration of follow-up was 19.4 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	204 of 990 (20.6%)	257 of 990 (26%)	Not reported
Evolocumab	212 of 983 (21.6%)	272 of 983 (27.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28207168Giugliano RP, Mach F, Zavitz K, Kurtz C, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Design and rationale of the EBBINGHAUS trial: A phase 3, 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 cognitive study of patients enrolled in the FOURIER trial. Clin Cardiol. 2017 Feb;40(2):59-65. doi: 10.1002/clc.22678. Epub 2017 Feb 16.
Background: PubMed 28813214Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med. 2017 Aug 17;377(7):633-643. doi: 10.1056/NEJMoa1701131.
Derived from this study: PubMed 33078867Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

416 sites in 30 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evolocumab and Background Statin Therapy in people with Dyslipidemia, run by Amgen at 416 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 416 sites in United States, Poland, Japan, United Kingdom, Czechia and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score (time frame: Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02207634, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.