Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study ID
NCT00575055
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • Bapineuzumab 0.5 mg/kg — DRUG
    given by infusion every 13 weeks for a total of 6 infusions.
  • Placebo Control — DRUG
    given by infusion every 13 weeks for a total of 6 infusions.
  • Bapineuzumab 1.0 m/kg — DRUG
    given by infusion every 13 weeks for a total of 6 infusions.

Study Details

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.

Key Dates

Start date
Dec 31, 2007
Status verified
Oct 2013
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012

Study Design

Enrollment
1,121 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bapineuzumab 0.5 mg/kg
    infusion every 13 weeks for a total of 6 infusions
  • Placebo Comparator: Placebo Dose
    infusion every 13 weeks for a total of 6 infusions.
  • Experimental: Bapineuzumab 1.0 m/kg
    infusion every 13 weeks for a total of 6 infusions.

Primary Outcome Measure

Cognitive and Functional [ Time Frame: 18 months ]

Locations (186)

FacilityCityStateZIPSite coordinators
University of Alabama Hospital (UAB)BirminghamAlabama35205-
Dedicated Clinical Research, Inc.GoodyearArizona85395-
Banner Alzheimer's InstitutePhoenixArizona85006-
HOPE Research Institute, LLCPhoenixArizona85050-
Banner Research InstituteSun CityArizona85351-
Northwest NeuroSpecialists, PLLCTucsonArizona85741-
University of Arizona College of Medicine, Health Sciences CenterTucsonArizona85724-
Clinical Trials Inc.Little RockArkansas72205-
East Bay Physicians Medical GroupBerkeleyCalifornia94705-
AVI Clinical ResearchCarsonCalifornia90746-
ATP Clinical Research, IncCosta MesaCalifornia92626-
Pharmacology Research InstituteEncinoCalifornia91316-
Margolin Brain InstituteFresnoCalifornia93720-
Neurology Center of North Orange CountyFullertonCalifornia92835-
Coordinated Clinical ResearchLa JollaCalifornia92037-
University of California San DiegoLa JollaCalifornia92037-
Senior Clinical Trials, IncLaguna HillsCalifornia92653-
Collaborative NeuroScience Network, Inc.Long BeachCalifornia90806-
Pharmacology Research InstituteLos AlamitosCalifornia90720-
UCLA Department of NeurologyLos AngelesCalifornia90095-
Vintage Institute for Clinical Research, IncLos AngelesCalifornia90035-
Pharmacology Research InstituteNewport BeachCalifornia92660-
Neurology CenterOceansideCalifornia92056-
University of California Irvine Medical CenterOrangeCalifornia92868-
Neuro-Therapeutics Inc.PasadenaCalifornia91105-
Sutter Neuroscience Medical GroupSacramentoCalifornia95816-
University of California Davis Alzheimer's Disease Research CenterSacramentoCalifornia95817-
Artemis Institute for Clinical ResearchSan DiegoCalifornia92123-
Sharp Mesa Vista HospitalSan DiegoCalifornia92123-
San Francisco Clinical Research CenterSan FranciscoCalifornia94109-
University of California at San Francisco Medical Center at ParnassusSan FranciscoCalifornia94117-
Neurological Research InstituteSanta MonicaCalifornia90404-
Schuster Medical Research InstituteSherman OaksCalifornia91403-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Alpine Clinical Research CenterBoulderColorado80304-
Mile High Research CenterDenverColorado80218-
Advanced Neurosciences Research, LLCFort CollinsColorado80528-
Associated Neurologists, PCDanburyConnecticut06810-
Associated Neurologists of Southern CT, P.C.FairfieldConnecticut06824-
Institute for Neurodegenerative DisordersNew HavenConnecticut06510-
Yale University School of MedicineNew HavenConnecticut06510-
Research Center for Clinical Studies, IncNorwalkConnecticut06851-
Chase Medical Research, LLCWaterburyConnecticut06708-
Christiana Care Health ServicesNewarkDelaware19713-
Georgetown University Medical CenterWashington D.C.District of Columbia20057-
JEM Research, LLCAtlantisFlorida33462-
Bradenton Research Center, IncBradentonFlorida34205-
Quantum Laboratories, Inc.Deerfield BeachFlorida33064-
Brain Matters ResearchDelray BeachFlorida33445-
Neurologic Consultants, P.A.Fort LauderdaleFlorida33308-
Clinical Physiology Associates, Inc.Fort MyersFlorida33916-
Neuropsychiatric Research Center of Southwest FloridaFort MyersFlorida33912-
Emerald Coast Mood & Memory, PA.Fort Walton BeachFlorida32547-
MD ClinicalHallandaleFlorida33009-
Mayo Clinic College of MedicineJacksonvilleFlorida32224-
Neurology AssociatesMaitlandFlorida32751-
Melbourne Internal Medicine Associates, MIMAMelbourneFlorida32901-
Allied Clinical Trials, Inc.MiamiFlorida33156-
Miami Jewish Health SystemsMiamiFlorida33137-
Pharmax Research Clinic, LLCMiamiFlorida33126-
Renstar Medical ResearchOcalaFlorida34471-
Compass Research, LLCOrlandoFlorida32806-
Palm Beach Neurological Center/Advanced Research ConsultantsPalm Beach GardensFlorida33418-
Neurostudies, IncPort CharlotteFlorida33952-
The Roskamp Institute, IncSarasotaFlorida34243-
Miami Research AssociatesSouth MiamiFlorida33143-
Meridien ResearchSt. PetersburgFlorida33709-
Suncoast Neuroscience Associates, Inc.St. PetersburgFlorida33713-
Axiom Clinical Research of FloridaTampaFlorida33609-
Johnnie B. Byrd Sr. Alzheimer's Center and Research InstituteTampaFlorida33613-
Stedman Clinical Trials, LLCTampaFlorida33613-
University of South Florida Suncoast Alzheimer's and Gerontology CenterTampaFlorida33613-
Premiere Research InstituteWest Palm BeachFlorida33407-
Emory University, School of MedicineAtlantaGeorgia30322-
Multiple Sclerosis Center of AtlantaAtlantaGeorgia30327-
NeuroTrials Research, Inc.AtlantaGeorgia30342-
Medical Research and Health Educational Foundation, IncColumbusGeorgia31909-
DeKalb Neurology Associates, LLCDecaturGeorgia30033-
Gwinnett Medical CenterLawrencevilleGeorgia30045-
University of Chicago Medical CenterChicagoIllinois60637-
Alexian Brothers Neurosciences InstituteElk Grove VillageIllinois60007-
Southern Illinois University, School of MedicineSpringfieldIllinois62794-
Elkhart Clinic, LLCElkhartIndiana46514-
Indiana University School of MedicineIndianapolisIndiana46202-
University of Kansas Medical CenterKansas CityKansas66160-
Mid America Neuroscience InstituteLenexaKansas66214-
Associates in Neurology, PSCLexingtonKentucky40513-
University of KentuckyLexingtonKentucky40536-
Four Rivers Clinical Research, IncPaducahKentucky42003-
Lake Charles Clinical TrialsLake CharlesLouisiana70629-
J. Gary Booker, MD, APMCShreveportLouisiana71104-
Louisiana State University Health Sciences CenterShreveportLouisiana70112-
Maine Medical Partners NeurologyScarboroughMaine04074-
Johns Hopkins University School of MedicineBaltimoreMaryland21224-
University of MarylandBaltimoreMaryland21201-
McLean HospitalBelmontMassachusetts02478-
Boston University School of MedicineBostonMassachusetts02118-
Brigham and Women's HospitalBostonMassachusetts02115-
ActivMed Practices and Research, IncHaverhillMassachusetts01830-
Neurocare, IncNewtonMassachusetts02459-
Neuroscience Research of the BerkshiresPittsfieldMassachusetts01201-
Donald S. Marks, MD, P.C.PlymouthMassachusetts02360-
Springfield Neurology AssociatesSpringfieldMassachusetts01104-
University of MichiganAnn ArborMichigan48105-
Henry Ford HospitalDetroitMichigan48202-
Michigan State UniversityEast LansingMichigan48824-
Saint Mary's Health CareGrand RapidsMichigan49503-
Borgess Medical Center/Borgess Research InstituteKalamazooMichigan49048-
Mayo ClinicRochesterMinnesota55905-
Hattiesburg ClinicHattiesburgMississippi39401-
Saint Luke's Hospital, Mid America Brain and Stroke InstituteKansas CityMissouri64111-
The Center for Pharmaceutical ResearchKansas CityMissouri64114-
St. Louis University School of MedicineSt LouisMissouri63104-
Washington University School of MedicineSt LouisMissouri63108-
Deaconess Billings Clinical Research CenterBillingsMontana59101-
Advanced Neurology SpecialistsGreat FallsMontana59405-
University of Nebraska Medical CenterOmahaNebraska68198-2045-
Cleveland Clinic Lou Ruvo Center for Brain HealthLas VegasNevada89106-
Memory Enhancement Center of America, Inc.EatontownNew Jersey07724-
The NeuroCognitive InstituteMount ArlingtonNew Jersey07856-
Alzheimer's Research Corporation (ARC)PatersonNew Jersey08759-
Princeton Medical InstitutePrincetonNew Jersey08540-
University of Medicine and Dentistry of New JerseyStratfordNew Jersey08084-
Albuquerque Neuroscience, Inc.AlbuquerqueNew Mexico87109-
Neurological Associates Albany PCAlbanyNew York12208-
Neuroscience Research Center at Albany Medical CenterAlbanyNew York12208-
Upstate Clinical Research, LLCAlbanyNew York12205-
Five Towns Neuroscience ResearchCedarhurstNew York11516-
Advanced BioBehavioral SciencesElmsfordNew York10523-
Empire Neurology, PCLathamNew York12110-
Neurological Care of CNYLiverpoolNew York13088-
Parker Jewish Institute for Health Care & RehabilitationNew Hyde ParkNew York11040-
Columbia University Medical CenterNew YorkNew York10032-
Mt. Sinai School of MedicineNew YorkNew York10029-
NYU School of Medicine/PsychiatryNew YorkNew York10016-
Nathan S. Kline Institute for Psychiatric ResearchOrangeburgNew York10962-
University of Rochester Medical Center @ Monroe Community HospitalRochesterNew York14620-
Duke University Medical CenterDurhamNorth Carolina27710-
Clinical Trials of America, IncHickoryNorth Carolina28601-
New Hope Clinical ResearchHickoryNorth Carolina28601-
Raleigh Neurology AssociatesRaleighNorth Carolina27607-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
University Hospitals of Cleveland, Case Medical Center, Memory and Cognition CenterBeachwoodOhio44122-
Neuro-Behavioral Clinical Research, IncCantonOhio44718-
NeuroCare Center, IncCantonOhio44718-
The Ohio State UniversityColumbusOhio43210-
Neurology Specialists, Inc.DaytonOhio45417-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Red River Medical Research Center, LLCOklahoma CityOklahoma73112-
Providence Medical Group-Medford NeurologyMedfordOregon97504-
Oregon Health & Sciences UniversityPortlandOregon97239-
Providence Health Service System, AD Center, Brain InstitutePortlandOregon97225-
Summit Research Group, LLCPortlandOregon97210-
Abington Neurological AssocAbingtonPennsylvania19001-
Lehigh Valley Health NetworkAllentownPennsylvania18103-
The Clinical Trial Center, LLCJenkintownPennsylvania19046-
Drexel University College of MedicinePhiladelphiaPennsylvania19102-
Jefferson Hospital for NeurosciencePhiladelphiaPennsylvania19107-
Penn Memory CenterPhiladelphiaPennsylvania19104-
Clinical Trials Research Services, LLCPittsburghPennsylvania15206-
University of VirginiaPittsburghPennsylvania15213-
Universtiy of PittsburghPittsburghPennsylvania15213-
Rhode Island Mood and Memory Research InstituteEast ProvidenceRhode Island02914-
Butler HospitalProvidenceRhode Island02906-
Rhode Island HospitalProvidenceRhode Island02903-
Medical University of South CarolinaNorth CharlestonSouth Carolina29406-
Avera Research InstituteSioux FallsSouth Dakota57105-
Neurology Clinic, PCCordovaTennessee38018-
Psychiatric Consultants, PCFranklinTennessee37067-
East Tennessee State UniversityJohnson CityTennessee37614-1707-
Volunteer Research GroupKnoxvilleTennessee37920-
Texas Neurology, PADallasTexas75214-
University of North Texas/Health Sciences Center-Fort WorthFort WorthTexas76106-
Baylor College of MedicineHoustonTexas77030-
Innovative Clinical TrialsSan AntonioTexas78229-
Integra Clinical Research, LLCSan AntonioTexas78231-
University of Utah, Dept. of NeurologySalt Lake CityUtah84108-
Wasatch Clinical ResearchSalt Lake CityUtah84107-
The Memory ClinicBenningtonVermont05201-
Fletcher Allen Health CareBurlingtonVermont05401-
Innovative Clinical Research CenterAlexandriaVirginia22304-
Alliance Research Group, LLCRichmondVirginia23230-
Pacific Medical CentersSeattleWashington98144-
University of Washington Veterans AffairsSeattleWashington98108-
University of Wisconsin School of Medicine and Public HealthMadisonWisconsin53705-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Alabama Hospital (UAB)· Birmingham, ALDedicated Clinical Research, Inc.· Goodyear, AZBanner Alzheimer's Institute· Phoenix, AZHOPE Research Institute, LLC· Phoenix, AZBanner Research Institute· Sun City, AZNorthwest NeuroSpecialists, PLLC· Tucson, AZ

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