AzTrials
AzTrials

Alzheimer's DiseasePhase 3NCT00574132

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

A Phase 3 study testing Bapineuzumab 0.5 mg/kg and Bapineuzumab 1.0 m/kg in people with Alzheimer's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 251 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

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 230 study sites in the US and Canada and up to 35 sites outside of North America will be involved. Read more about this study

Who is it for?
Ages 50 to 88 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Bapineuzumab 0.5 mg/kg and Bapineuzumab 1.0 m/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,331 participants
Where
251 sitesin 4 countries
Study dates
Dec 2007to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

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 50 to 88 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of probable AD
  • Age from 50 to less than 89
  • Mini-Mental Status Exam score of 16-26 inclusive
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all clinic visits with patient

Who cannot join

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
  • Smoking greater than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
Show all 9Show fewer
  • Prior treatment experimental immunotherapeutics or vaccines for AD
  • Women of childbearing potential
  • Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Trial locations and contacts

251 sites in 4 countries.

251 sites in 4 countries

United States219 sites

  • Abington Neurological Associates, Ltd

    Abington, Pennsylvania, 19001

  • Upstate Clinical Research, LLC

    Albany, New York, 12205

  • Neurological Associates of Albany, P.C.

    Albany, New York, 12208

  • Neuroscience Research Center at Albany Medical Center

    Albany, New York, 12208

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • University of New Mexico, Health Sciences Center

    Albuquerque, New Mexico, 87131

  • Innovative Clinical Research Center

    Alexandria, Virginia, 22304

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • University of Michigan

    Ann Arbor, Michigan, 48105

  • Emory University/School of Medicine

    Atlanta, Georgia, 30322

  • MS Center of Atlanta

    Atlanta, Georgia, 30327

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30342

  • JEM Research, LLC

    Atlantis, Florida, 33462

  • Senior Adults Specialty Research (SASR)

    Austin, Texas, 78757

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21224

  • Rakesh Ranjan, M.D. & Associates, Inc.

    Beachwood, Ohio, 44125

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • The Memory Clinic

    Bennington, Vermont, 05201

  • East Bay Physicians Medical Group

    Berkeley, California, 94705

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Deaconess Billings Clinical Research Center

    Billings, Montana, 59101

  • University of Alabama Hospital (UAB)

    Birmingham, Alabama, 35205

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • Alpine Clinical Research Center

    Boulder, Colorado, 80304

  • Bradenton Research Center, Inc

    Bradenton, Florida, 34205

  • Social Psychiatry Research Institute

    Brooklyn, New York, 11235

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Neuro-Behavioral Clinical Research, Inc

    Canton, Ohio, 44718

  • NeuroCare Center, Inc

    Canton, Ohio, 44718

  • AVI Clinical Research

    Carson, California, 90746

  • Five Towns Neuroscience Research

    Cedarhurst, New York, 11516

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University Memory and Aging Center University Hospitals of Cleveland/Case Medical Center

    Cleveland, Ohio, 44120

  • Medical Research and Health Education Foundation, Inc.

    Columbus, Georgia, 31909

  • Ohio State University

    Columbus, Ohio, 43210

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018

  • ATP Clinical Research, Inc

    Costa Mesa, California, 92626

  • Texas Neurology, PA

    Dallas, Texas, 75214

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Associated Neurologists, PC

    Danbury, Connecticut, 06810

  • Neurology Specialists, Inc.

    Dayton, Ohio, 45417

  • Dekalb Neurology Associates

    Decatur, Georgia, 30033

  • Quantum Laboratories, Inc.

    Deerfield Beach, Florida, 33064

  • Brain Matters Research, Inc.

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Coastal Neurology, PA

    Dover, New Hampshire, 03820

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Michigan State University

    East Lansing, Michigan, 48824

  • Rhode Island Mood and Memory Research Institute

    East Providence, Rhode Island, 02914

  • The Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Neurosciences Institute

    Elk Grove Village, Illinois, 60007

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514

  • Advanced Bio-Behavioral Sciences

    Elmsford, New York, 10523

  • Pharmacology Research Institute

    Encino, California, 91316

  • Associated Neurologists of Southern CT, P.C.

    Fairfield, Connecticut, 06824

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Advanced Neurosciences Research, LLC

    Fort Collins, Colorado, 80528

  • Neurologic Consultants, P.A.

    Fort Lauderdale, Florida, 33308

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Clinical Physiology Associates, Inc.

    Fort Myers, Florida, 33916

  • Emerald Coast Mood & Memory, PA.

    Fort Walton Beach, Florida, 32547

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805

  • University of North Texas/Health Sciences Center-Fort Worth

    Fort Worth, Texas, 76106

  • Psychiatric Consultants, PC

    Franklin, Tennessee, 37067

  • Margolin Brain Institute

    Fresno, California, 93720

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Integrated Medical and Behavioral Associates

    Glendale, California, 91204

  • Dedicated Clinical Research, Inc.

    Goodyear, Arizona, 85395

  • Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Advanced Neurology Specialists

    Great Falls, Montana, 59405

  • MD Clinical

    Hallandale, Florida, 33009

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • ActivMed Practices and Research, Inc

    Haverhill, Massachusetts, 01830

  • Clinical Trials of America, Inc

    Hickory, North Carolina, 28601

  • New Hope Clinical Research

    Hickory, North Carolina, 28601

  • Sunrise Clinical Research, Inc.

    Hollywood, Florida, 33021

  • Claghorn-Lesem Research Clinic, Ltd.

    Houston, Texas, 77008

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Sun Valley Behavioral Medical Center

    Imperial, California, 92251

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Mayo Clinic College of Medicine

    Jacksonville, Florida, 32224

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • East Tennessee State University

    Johnson City, Tennessee, 37614-1707

  • Borgess Medical Center/Borgess Research Institute

    Kalamazoo, Michigan, 49048

  • Kansas Multi-Specialist Group

    Kansas City, Kansas, 66112

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital, Mid America Brain and Stroke Institute

    Kansas City, Missouri, 64111

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Coordinated Clinical Research

    La Jolla, California, 92037

  • University of California San Diego/Shela Marcos Alzheimer's Disease Research Center

    La Jolla, California, 92037

  • Senior Clinical Trials

    Laguna Hills, California, 92653

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • Empire Neurology, PC

    Latham, New York, 12110

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Dartmouth Hitchcock Medical Center, Dept of Neurology

    Lebanon, New Hampshire, 03756

  • Mid America Neuroscience Institute

    Lenexa, Kansas, 66214

  • Associates in Neurology, PSC

    Lexington, Kentucky, 40513

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Clinical Trials Inc.

    Little Rock, Arkansas, 72205

  • Neurological Care of CNY

    Liverpool, New York, 13088

  • Collaborative Neuroscience Network

    Long Beach, California, 90806

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Vintage Institute for Clinical Research, Inc

    Los Angeles, California, 90035

  • UCLA Department of Neurology

    Los Angeles, California, 90095

  • University of Wisconson Medical School of Medicine and Public Health

    Madison, Wisconsin, 53705

  • Neurology Associates

    Maitland, Florida, 32751

  • Providence Medical Group-Medford Neurology

    Medford, Oregon, 97504

  • Melbourne International Medicine Associates, MIMA

    Melbourne, Florida, 32901

  • Pharmax Research Clinic, LLC

    Miami, Florida, 33126

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Allied Clinical Trials, Inc.

    Miami, Florida, 33156

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • The NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Synergy Research

    National City, California, 91950

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Yale University School of Medicine, Alzheimer's Disease Research Unit

    New Haven, Connecticut, 06510

  • Parker Jewish Institute for Health Care & Rehabilitation

    New Hyde Park, New York, 11040

  • Louisiana Research Associates, Inc.

    New Orleans, Louisiana, 70114

  • NYU School of Medicine/Psychiatry

    New York, New York, 10016

  • Mt. Sinai School of Medicine

    New York, New York, 10029

  • Columbia University/Medical Center

    New York, New York, 10032

  • Dent Neurologic Institute

    New York, New York, 14226

  • Christiana Care Health Services

    Newark, Delaware, 19713

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Neurocare, Inc.

    Newton, Massachusetts, 02459

  • Medical University of South Carolina

    North Charleston, South Carolina, 29406

  • Research Center for Clinical Studies, Inc

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34471

  • The Neurology Center

    Oceanside, California, 92056

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Red River Medical Research Center, LLC

    Oklahoma City, Oklahoma, 73112

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • Nathan S. Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Four Rivers Clinical Research

    Paducah, Kentucky, 42003

  • Palm Beach Neurological Center/Advanced Research Consultants

    Palm Beach Gardens, Florida, 33418

  • Neuro-Therapeutics Inc.

    Pasadena, California, 91105

  • Alzheimer's Research Corporation (ARC)

    Paterson, New Jersey, 08759

  • Broward Research Group, Inc.

    Pembroke Pines, Florida, 33026

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61602

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Penn Memory Center

    Philadelphia, Pennsylvania, 19104

  • Jefferson Hospital for Neuroscience

    Philadelphia, Pennsylvania, 19107

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • HOPE Research Institute, LLC

    Phoenix, Arizona, 85050

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania, 15206

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Neuroscience Research of the Berkshires

    Pittsfield, Massachusetts, 01201

  • Donald S. Marks, MD, P.C.

    Plymouth, Massachusetts, 02360

  • Neurostudies, Inc

    Port Charlotte, Florida, 33952

  • Summit Research Group, Inc.

    Portland, Oregon, 97210

  • Providence Health Service System, AD Center, Brain Institute

    Portland, Oregon, 97225

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

  • Princeton Medical Institute

    Princeton, New Jersey, 08540

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • The Southwest Institute for Clinical Research, Inc.

    Rancho Mirage, California, 92270

  • Alliance Research Group, LLC

    Richmond, Virginia, 23230

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center @ Monroe Community Hospital

    Rochester, New York, 14620

  • CBH Health, LLC

    Rockville, Maryland, 20850

  • Sutter Neuroscience Medical Group

    Sacramento, California, 95816

  • University of California, Davis, Alzheimer's Disease Center

    Sacramento, California, 95817

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • University of Utah, Dept of Neurology

    Salt Lake City, Utah, 84108

  • Innovative Clinical Trials

    San Antonio, Texas, 78229

  • Integra Clinical Research, LLC

    San Antonio, Texas, 78231

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • University of California, San Francisco

    San Francisco, California, 94117

  • Neuropsychiatric Research Center of Orange County

    Santa Ana, California, 92701

  • Neurological Research Institute

    Santa Monica, California, 90404

  • Roskamp Institute

    Sarasota, Florida, 34243

  • Maine Medical Partners Neurology

    Scarborough, Maine, 04074

  • University of Washington Veterans Affairs

    Seattle, Washington, 98108

  • Pacific Medical Centers

    Seattle, Washington, 98144

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403

  • Louisana State University Health Sciences Center

    Shreveport, Louisiana, 70112

  • J. Gary Booker, MD, APMC

    Shreveport, Louisiana, 71104

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • Miami Research Associates

    South Miami, Florida, 33143

  • Southern Illinois University, School of Medicine

    Springfield, Illinois, 62794-9643

  • Memory Wellness Clinic

    Springfield, Massachusetts, 01104

  • Springfield Neurology Associates

    Springfield, Massachusetts, 01104

  • St. Louis University School of Medicine

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63108

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33713

  • University of Medicine and Dentistry of New Jersey

    Stratford, New Jersey, 08084

  • Banner Research Institute

    Sun City, Arizona, 85351

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute

    Tampa, Florida, 33613

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • University of South Florida Suncoast Alzheimer's and Gerontology Center

    Tampa, Florida, 33613

  • Neurology and Neuroscience Center of Ohio

    Toledo, Ohio, 43623

  • Shore Neurology, P.A.

    Toms River, New Jersey, 08755

  • University of Arizona College of Medicine, Health Science Center

    Tucson, Arizona, 85724-5023

  • Northwest Neurospecialists, PLLC

    Tucson, Arizona, 85741

  • Diablo Clinical Research, Inc

    Walnut Creek, California, 94598

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Independent Pyschiatric Consultants

    Waukesha, Wisconsin, 53188

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Coastal Research Associates, Inc.

    Weymouth, Massachusetts, 02190

  • Grayline Clinical Drug Trials, Inc

    Wichita Falls, Texas, 76309

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada18 sites

  • University of Calgary, Foothills Medical Centre

    Calgary, Alberta, T2N 4Z6

  • Neuro Rive-Sud Memory Clinic

    Greenfield Park, Quebec, J4V 2J2

  • Medical Arts Health Research Group

    Kamloops, British Columbia, V2C 1K7

  • Medical Arts Health Research Group

    Kelowna, British Columbia, V1Y 3G8

  • Hotel Dieu Hospital/Queens University Memorial Clinics

    Kingston, Ontario, K7L 5G2

  • Saint Joseph's Health Care London, Saint Joseph's Hospital

    London, Ontario, N6A 4V2

  • Parkwood Hospital

    London, Ontario, N6C 5J1

  • Hopital Maisonneuve-Rosemont, Comite d' ethique de la recherche

    Montreal, Quebec, H1T 2M4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • Medical Arts Health Research Group

    Penticton, British Columbia, V2A 5C8

  • Kawartha Regional Memory Clinic

    Peterborough, Ontario, K9H 2P4

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, JIH 1Z1

  • Neurology Research Inch./Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • Toronto Centre for Memory and Aging

    Toronto, Ontario, M6M 3Z5

  • University of British Columbia (UBC) Hospital

    Vancouver, British Columbia, V5Z 3T7

  • Douglas Mental Health University Institute

    Verdun, Quebec, H4H 1R3

  • Ontario Shores Centre for Mental Health Scienes

    Whitby, Ontario, L1N 5S9

Other trials in Canada

Germany12 sites

  • Saint Josefs Hospital

    Bochum, North Rhine-Westphalia, 44791

  • ABX-CRO advanced pharmaceutical services Forschungsgesellschaft GmbH

    Dresden, Saschen, 01307

  • Universitätsklinik Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitätsklinikum Ulm

    Günzburg, Bavaria, 89312

  • UKE Hamburg

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, Saarland, 66421

  • AFL Arzneimittelforschung Leipzig GmbH

    Leipzig, Sachen, 04107

  • Ludwig-Maximilians-Universität München

    München, Bavaria, 80336

  • Klinikum Rechts der Isar der Technischen Universität München

    München, Bavaria, 81675

  • Universitätsklinikum Regensburg

    Regensburg, Byern, 93053

  • Universitätsklinik Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinik Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Austria2 sites

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090

Other trials in Austria

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Non- Carriers.

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 230 study sites in the US and Canada and up to 35 sites outside of North America 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.

Being tested
Bapineuzumab 0.5 mg/kg, Placebo Control, Bapineuzumab 1.0 m/kg
Medical subject headings
Alzheimer Disease

What participants receive

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

  • Bapineuzumab 0.5 mg/kgDrug

    Also called AAB-001

    infusion every 13 weeks for a total of 6 infusions

  • Placebo ControlDrug

    given by infusion every 13 weeks for a total of 6 infusions.

  • Bapineuzumab 1.0 m/kgDrug

    Also called AAB-001

    infusion every 13 weeks for a total of 6 infusions

Study groups in NCT00574132
Study groupRoleWhat they receive
Bapineuzumab 0.5 mg/kgExperimentalinfusion every 13 weeks for a total of 6 infusions
Receives: Drug: Bapineuzumab 0.5 mg/kg
Placebo ControlPlacebo comparatorinfusion every 13 weeks for a total of 6 infusions.
Receives: Drug: Placebo Control
Bapineuzumab 1.0 m/kgExperimentalinfusion every 13 weeks for a total of 6 infusions.
Receives: Drug: Bapineuzumab 1.0 m/kg

What is being measured

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

  1. Cognitive and Functional

    Measured: 18 months

Secondary outcomes (2)

  1. Cognitive and Global

    Measured: 18 months

  2. Imaging and biochemical biomarkers of disease status

    Measured: 18 months

Timeline

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

  1. First posted17 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00574132
Sponsor's protocol ID
ELN115727-301
Status last verified
Oct 2013
First submitted
10 Dec 2007
Last updated
25 Nov 2013
Results posted
No

Publications

  • Brashear HR, Ketter N, Bogert J, Di J, Salloway SP, Sperling R. Clinical Evaluation of Amyloid-Related Imaging Abnormalities in Bapineuzumab Phase III Studies. J Alzheimers Dis. 2018;66(4):1409-1424. doi: 10.3233/JAD-180675.

    PubMed 30412493

  • Samtani MN, Xu SX, Russu A, Adedokun OJ, Lu M, Ito K, Corrigan B, Raje S, Brashear HR, Styren S, Hu C. Alzheimer's disease assessment scale-cognitive 11-item progression model in mild-to-moderate Alzheimer's disease trials of bapineuzumab. Alzheimers Dement (N Y). 2015 Oct 9;1(3):157-169. doi: 10.1016/j.trci.2015.09.001. eCollection 2015 Nov.

    PubMed 29854935

  • Xu SX, Samtani MN, Russu A, Adedokun OJ, Lu M, Ito K, Corrigan B, Raje S, Brashear HR, Styren S, Hu C. Alzheimer's disease progression model using disability assessment for dementia scores from bapineuzumab trials. Alzheimers Dement (N Y). 2015 Jul 21;1(2):141-149. doi: 10.1016/j.trci.2015.06.005. eCollection 2015 Sep.

    PubMed 29854934

  • Ketter N, Brashear HR, Bogert J, Di J, Miaux Y, Gass A, Purcell DD, Barkhof F, Arrighi HM. Central Review of Amyloid-Related Imaging Abnormalities in Two Phase III Clinical Trials of Bapineuzumab in Mild-To-Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;57(2):557-573. doi: 10.3233/JAD-160216.

    PubMed 28269765

  • Liu E, Schmidt ME, Margolin R, Sperling R, Koeppe R, Mason NS, Klunk WE, Mathis CA, Salloway S, Fox NC, Hill DL, Les AS, Collins P, Gregg KM, Di J, Lu Y, Tudor IC, Wyman BT, Booth K, Broome S, Yuen E, Grundman M, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Amyloid-beta 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials. Neurology. 2015 Aug 25;85(8):692-700. doi: 10.1212/WNL.0000000000001877. Epub 2015 Jul 24.

    PubMed 26208959

  • Salloway S, Sperling R, Fox NC, Blennow K, Klunk W, Raskind M, Sabbagh M, Honig LS, Porsteinsson AP, Ferris S, Reichert M, Ketter N, Nejadnik B, Guenzler V, Miloslavsky M, Wang D, Lu Y, Lull J, Tudor IC, Liu E, Grundman M, Yuen E, Black R, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):322-33. doi: 10.1056/NEJMoa1304839.

    PubMed 24450891

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bapineuzumab 0.5 mg/kg and Bapineuzumab 1.0 m/kg in people with Alzheimer's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 251 sites in 4 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 6 inclusion and 9 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 251 sites in United States, Canada, Germany, Austria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cognitive and Functional (time frame: 18 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 NCT00574132, which also lists 6 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 25 Nov 2013.

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