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Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients


Study Overview

Record IDs:

ADEAR: IA0197, NLM: NCT00667810

Current Status:

Recruiting

Purpose:

This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Sponsor(s):

Pfizer

Official Title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy And Safety Trial Of Bapineuzumab In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E ε4 Non-Carriers

Principal Investigator(s):

Study Director, Pfizer

Start Date:

May 2008

Anticipated End Date:

June 2014

Expected Enrollment:

1000


Qualifications for this Study

Minimum Age Maximum Age Gender Accepts Healthy Volunteers? Disease Stage Inpatient/Outpatient
50 88 Both No Early
Middle
Outpatient


Inclusion Criteria:

  • Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD
  • Concurrent use of cholinesterase inhibitor or memantine allowed, if stable
  • Caregiver will participate and be able to attend clinic visits with patient


Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body]
  • Women of childbearing potential


Prohibited Medications:



    Study Description



    Phase 3, Treatment, Randomized, Double Blind , Placebo, Parallel, Safety/Efficacy  Study

    Intervention Type Name Manufacturer Classification
    Drug bapineuzumab (AAB-001) Pfizer humanized monoclonal antibody


     

    Study Contact

    Name:

    Pfizer CT.gov Call Center 

    Telephone:

    1-800-718-1021

    Email:


    All U.S. Trial Sites:

    State City Zip Code Location Contact
    AlabamaBirmingham35294Pfizer Investigational Site
     
    ArizonaGoodyear85395Pfizer Investigational Site
     
    ArizonaPhoenix85050Pfizer Investigational Site
     
    ArizonaPhoenix85032Pfizer Investigational Site
     
    ArizonaPhoenix85006Pfizer Investigational Site
     
    ArkansasLittle Rock72205Pfizer Investigational Site
     
    CaliforniaCosta Mesa92626Pfizer Investigational Site
    CaliforniaEncino91316Pfizer Investigational Site
    CaliforniaFresno93720Pfizer Investigational Site
     
    CaliforniaLa Jolla92037Pfizer Investigational Site
     
    CaliforniaLaguna Hills92653Pfizer Investigational Site
    CaliforniaLoma Linda92354Pfizer Investigational Site
    CaliforniaLong Beach90806Pfizer Investigational Site
     
    CaliforniaLos Alamitos90720Pfizer Investigational Site
    CaliforniaNewport Beach92660Pfizer Investigational Site
    CaliforniaSan Diego92123Pfizer Investigational Site
    CaliforniaSan Francisco94109Pfizer Investigational Site
     
    ColoradoBoulder80304Pfizer Investigational Site
     
    ColoradoDenver80218Pfizer Investigational Site
     
    Connecticut Danbury06810Pfizer Investigational Site
    Connecticut Fairfield06824Pfizer Investigational Site
     
    Connecticut Greenwich06830Pfizer Investigational Site
     
    Connecticut New Haven06510Pfizer Investigational Site
    Connecticut New Haven06511Pfizer Investigational Site
     
    Connecticut New Haven06520Pfizer Investigational Site
     
    Connecticut New Haven06519Pfizer Investigational Site
     
    Connecticut New Haven06510Pfizer Investigational site
     
    Connecticut Norwalk06851Pfizer Investigational Site
     
    Connecticut Waterbury06708Pfizer Investigational Site
     
    FloridaAtlantis33462Pfizer Investigational Site
     
    FloridaBradenton34205Pfizer Investigational Site
    FloridaDelray Beach33445Pfizer Investigational Site
     
    FloridaFort Myers33916Pfizer Investigational Site
    FloridaFort Myers33901Pfizer Investigational Site
    FloridaFort Walton Beach32547Pfizer Investigational Site
     
    FloridaHallandale Beach33009Pfizer Investigational Site
     
    FloridaMiami33176Pfizer Investigational Site
    FloridaOcala34481Pfizer Investigational Site
     
    FloridaOcala34471Pfizer Investigational Site
     
    FloridaOrlando32806Pfizer Investigational Site
    FloridaPalm Beach Gardens33418Pfizer Investigational Site
     
    FloridaPort Charlotte33952Pfizer Investigational Site
     
    FloridaSarasota34243Pfizer Investigational Site
     
    FloridaSun City33573Pfizer Investigational Site
    FloridaTampa33613Pfizer Investigational Site
    FloridaWest Palm Beach33407Pfizer Investigational Site
     
    GeorgiaAtlanta30342Pfizer Investigational Site
    GeorgiaColumbus31909Pfizer Investigational Site
    GeorgiaColumbus31901Pfizer Investigational Site
    GeorgiaDecatur30033Pfizer Investigational Site
     
    GeorgiaLawrenceville30045Pfizer Investigational Site
     
    GeorgiaLawrenceville30046Pfizer Investigational Site
     
    IllinoisElk Grove Village60007Pfizer Investigational Site
     
    IllinoisPeoria61602Pfizer Investigational Site
     
    IllinoisPeoria61636Pfizer Investigational Site
     
    IllinoisPeoria61606Pfizer Investigational Site
     
    IllinoisSpringfield62781Pfizer Investigational Site
     
    IllinoisSpringfield62702Pfizer Investigational Site
     
    IndianaElkhart46514Pfizer Investigational Site
     
    IndianaMishawaka46545Pfizer Investigational Site
     
    KansasWichita67207Pfizer Investigational Site
     
    KansasWichita67205Pfizer Investigational Site
     
    KentuckyPaducah42003Pfizer Investigational Site
     
    LouisianaLake Charles70629Pfizer Investigational Site
     
    LouisianaNew Orleans70114Pfizer Investigational Site
     
    MarylandBethesda20814Pfizer Investigational Site
    MarylandRockville20850Pfizer Investigational Site
    MassachusettsBoston02114Pfizer Investigational Site
    MassachusettsBoston02115Pfizer Investigational Site
     
    MassachusettsBoston02118Pfizer Investigational Site
     
    MassachusettsHaverhill01830Pfizer Investigational Site
    MassachusettsNewton02459Pfizer Investigational Site
    MassachusettsPittsfield01201Pfizer Investigational Site
     
    MassachusettsSpringfield01104Pfizer Investigational Site
     
    MichiganAnn Arbor48109-5872Pfizer Investigational Site
     
    MichiganAnn Arbor48109Pfizer Investigational Site
     
    MichiganAnn Arbor48110Pfizer Investigational Site
     
    MichiganEast Lansing48824Pfizer Investigational Site
     
    MichiganLansing48910Pfizer Investigational Site
     
    MississippiFlowood39232Pfizer Investigational Site
     
    MississippiHattiesburg39401Pfizer Investigational Site
     
    MissouriKansas City64114Pfizer Investigational Site
     
    MontanaGreat Falls59405Pfizer Investigational Site
    New JerseyBerlin08009Pfizer Investigational Site
    New JerseyEatontown07724Pfizer Investigational Site
     
    New JerseyManchester08759Pfizer Investigational Site
     
    New JerseyToms River08755Pfizer Investigational Site
     
    New YorkBrewster10509Pfizer Investigational Site
    New YorkLiverpool13088Pfizer Investigational Site
     
    New YorkRochester14642Pfizer Investigational Site
     
    New YorkRochester14620Pfizer Investigational Site
     
    North CarolinaCharlotte28211Pfizer Investigational Site
     
    North CarolinaHickory28602Pfizer Investigational Site
     
    North CarolinaHickory28601Pfizer Investigational Site
     
    North CarolinaRaleigh27607Pfizer Investigational Site
     
    OhioColumbus43210Pfizer Investigational Site
     
    OhioToledo43623Pfizer Investigational Site
     
    OklahomaOklahoma City73134Pfizer Investigational Site
    OklahomaOklahoma City73112Pfizer Investigational Site
    OregonPortland97225Pfizer Investigational Site
     
    PennsylvaniaAbington19001Pfizer Investigational Site
     
    PennsylvaniaJenkintown19046Pfizer Investigational Site
     
    PennsylvaniaPhiladelphia19104Pfizer Investigational Site
     
    PennsylvaniaPhiladelphia19107Pfizer Investigational Site
     
    PennsylvaniaPittsburgh15206Pfizer Investigational Site
     
    PennsylvaniaWillow Grove19090Pfizer Investigational Site
     
    Rhode IslandEast Providence02914Pfizer Investigational Site
     
    Rhode IslandPawtucket02861Pfizer Investigational Site
     
    Rhode IslandProvidence02906Pfizer Investigational Site
     
    South CarolinaCharleston29425Pfizer Investigational Site
     
    South CarolinaGreer29651Pfizer Investigational Site
    South CarolinaNorth Charleston29406Pfizer Investigational Site
     
    TennesseeCordova38018Pfizer Investigational Site
     
    TexasDallas75214Pfizer Investigational Site
     
    TexasFort Worth76107Pfizer Investigational Site
     
    TexasSan Antonio78231Pfizer Investigational Site
     
    TexasSan Antonio78229Pfizer Investigational Site
     
    TexasSan Antonio78258Pfizer Investigational Site
     
    TexasWichita Falls86309Pfizer Investigational Site
     
    VermontBennington05201Pfizer Investigational Site
     
    VirginiaAlexandria22304Pfizer Investigational Site
    VirginiaCharlottesville22908Pfizer Investigational Site
     
    VirginiaCharlottesville22903Pfizer Investigational Site
     
    WashingtonBothell98021Pfizer Investigational Site
     
    WashingtonSeattle98144Pfizer Investigational Site
     


    Trial Sites Outside U.S.:

    Country State City Zip Code Location Contact
    Canada Ontario North York M6M 3Z5 Pfizer Investigational Site
     
    Canada Ontario Ottawa K1N 5C8 Pfizer Investigational Site
     
    Canada Ontario Toronto M4N 3M5 Pfizer Investigational Site
     
    Canada Ontario Toronto M3B 2S7 Pfizer Investigational Site
     
    Canada Quebec Montreal H1T 2M4 Pfizer Investigational Site
     
    Canada Quebec Sherbrooke J1H 1Z1 Pfizer Investigational Site
     
    Canada Quebec Quebec G3K 2P8 Pfizer Investigational Site
     
    Canada Quebec L'Ancienne-Lorette G2E 2X1 Pfizer Investigational Site
    Mexico Aguascalientes Aguascalientes 20127 Pfizer Investigational Site
     
    Mexico Baja California Mexicali 21100 Pfizer Investigational Site
     
    Mexico Nuevo Leon Monterrey 64000 Pfizer Investigational Site
     

     

    Links:




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