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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT02207634
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
  • Placebo — DRUG
    Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
  • Background Statin Therapy — DRUG
    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 Details

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.

Key Dates

Start date
Sep 10, 2014
Status verified
Dec 2017
Primary completion
Nov 11, 2016
Completion
Nov 11, 2016

Study Design

Enrollment
1,974 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo
    Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study.
  • Experimental: Evolocumab
    Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.

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). ]

Locations (134)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35294-
Research SiteHuntsvilleAlabama35801-
Research SiteMobileAlabama36608-
Research SiteGlendaleArizona85306-
Research SitePhoenixArizona85018-
Research SiteAlhambraCalifornia91801-
Research SiteBanningCalifornia92220-
Research SiteHarbor CityCalifornia90710-
Research SiteLaguna HillsCalifornia92653-
Research SiteLong BeachCalifornia90807-
Research SiteLong BeachCalifornia90822-
Research SiteOceansideCalifornia92056-
Research SiteOxnardCalifornia93030-
Research SitePalm SpringsCalifornia92262-
Research SiteRosevilleCalifornia95661-
Research SiteSacramentoCalifornia95816-
Research SiteSan PedroCalifornia90732-
Research SiteTarzanaCalifornia91356-
Research SiteThousand OaksCalifornia91360-
Research SiteAuroraColorado80012-
Research SiteColorado SpringsColorado80909-
Research SiteDenverColorado80218-
Research SiteBridgeportConnecticut06610-
Research SiteBoynton BeachFlorida33472-
Research SiteCrystal RiverFlorida34429-
Research SiteDaytona BeachFlorida32117-
Research SiteDeerfield BeachFlorida33442-
Research SiteFleming IslandFlorida32003-
Research SiteHollywoodFlorida33021-
Research SiteHollywoodFlorida33024-
Research SiteJacksonvilleFlorida32216-
Research SiteMiamiFlorida33144-
Research SitePalm HarborFlorida34684-
Research SitePembroke PinesFlorida33025-
Research SitePonte VedraFlorida32081-
Research SiteSarasotaFlorida34232-
Research SiteSt. PetersburgFlorida33713-
Research SiteTampaFlorida33614-
Research SiteWest Palm BeachFlorida33401-
Research SiteAtlantaGeorgia30342-
Research SiteAugustaGeorgia30909-
Research SiteGainesvilleGeorgia30501-
Research SiteSavannahGeorgia31406-
Research SiteSuwaneeGeorgia30024-
Research SiteCoeur d'AleneIdaho83814-
Research SiteAddisonIllinois60101-
Research SiteBellevilleIllinois62220-
Research SiteChicagoIllinois60616-
Research SiteJerseyvilleIllinois62052-
Research SiteHammondIndiana46320-
Research SiteWaterlooIowa50702-
Research SiteHutchinsonKansas67502-
Research SiteLexingtonKentucky40503-
Research SiteOwensboroKentucky42303-
Research SiteBaton RougeLouisiana70808-
Research SiteHammondLouisiana70403-
Research SiteLafayetteLouisiana70508-
Research SiteMetairieLouisiana70006-
Research SiteMonroeLouisiana71201-
Research SiteSlidellLouisiana70458-
Research SiteBiddefordMaine04005-
Research SiteSalisburyMaryland21804-
Research SiteTowsonMaryland21204-
Research SiteHaverhillMassachusetts01830-
Research SiteNewtonMassachusetts02459-
Research SiteAnn ArborMichigan48106-
Research SiteGrandvilleMichigan49418-
Research SiteLansingMichigan48912-
Research SiteMuskegonMichigan49444-
Research SiteSaint PaulMinnesota55102-
Research SiteJefferson CityMissouri65109-
Research SiteSt LouisMissouri63117-
Research SiteSt LouisMissouri63128-
Research SiteGreat FallsMontana59405-
Research SiteKalispellMontana59901-
Research SiteVoorhees TownshipNew Jersey08043-
Research SiteWestwoodNew Jersey07675-
Research SiteBrooklynNew York11206-
Research SiteBuffaloNew York14215-
Research SiteCortlandt ManorNew York10567-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew WindsorNew York12553-
Research SiteRochesterNew York14609-
Research SiteTroyNew York12180-
Research SiteWest SenecaNew York14224-
Research SiteWilliamsvilleNew York14221-
Research SiteCalabashNorth Carolina28467-
Research SiteHickoryNorth Carolina28601-
Research SiteHickoryNorth Carolina28602-
Research SiteMooresvilleNorth Carolina28117-
Research SiteRaleighNorth Carolina27609-
Research SiteTabor CityNorth Carolina28463-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteGrand ForksNorth Dakota58201-
Research SiteCantonOhio44708-
Research SiteCincinnatiOhio45219-
Research SiteColumbusOhio43201-
Research SiteColumbusOhio43215-
Research SiteDaytonOhio45414-
Research SiteSpringfieldOhio45505-
Research SiteToledoOhio43615-
Research SitePryorOklahoma74362-
Research SiteBendOregon97701-
Research SitePortlandOregon97225-
Research SitePortlandOregon97239-
Research SiteCamp HillPennsylvania17011-
Research SiteChambersburgPennsylvania17201-
Research SiteFeastervillePennsylvania19053-
Research SitePhiladelphiaPennsylvania19152-
Research SitePittsburghPennsylvania15206-
Research SitePawtucketRhode Island02860-
Research SiteFort MillSouth Carolina29707-
Research SiteMoncks CornerSouth Carolina29461-
Research SiteMt. PleasantSouth Carolina29464-
Research SiteNorth Myrtle BeachSouth Carolina29582-
Research SiteRapid CitySouth Dakota57701-
Research SiteJacksonTennessee38305-
Research SiteNashvilleTennessee37203-
Research SiteTullahomaTennessee37388-
Research SiteAustinTexas78758-
Research SiteDallasTexas75216-
Research SiteHoustonTexas77025-
Research SiteHoustonTexas77030-
Research SitePlanoTexas75024-
Research SiteWichita FallsTexas76301-
Research SiteWest JordanUtah84088-
Research SiteBurkeVirginia22015-
Research SiteFalls ChurchVirginia22042-
Research SiteHopewellVirginia23860-
Research SiteRichmondVirginia23219-
Research SiteRichmondVirginia23294-
Research SiteSuffolkVirginia23435-
Research SiteSeattleWashington98195-
Research SiteGreen BayWisconsin54301-

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