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AzTrials

Alzheimer's DiseasePhase 3NCT00937352

A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

A Phase 3 study testing Bapineuzumab in people with Alzheimer's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 191 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302. Read more about this study

Who is it for?
Ages 51 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Bapineuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
896 participants
Where
191 sitesin 3 countries
Study dates
Jul 2009to Sep 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 51 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of probable AD
  • Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
  • Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
  • Caregiver able to attend all clinic visits with patient

Who cannot join

  • Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
  • Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
  • Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)

Trial locations and contacts

191 sites in 3 countries.

191 sites in 3 countries

United States176 sites

  • Abington Neurological Associates, Ltd.

    Abington, Pennsylvania, 19001

  • Upstate Clinical Research, LLC

    Albany, New York, 12205

  • Neurological Associates of Albany, PC

    Albany, New York, 12208

  • Neuroscience Research Center at Albany Medical Center

    Albany, New York, 12208

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • Innovative Clinical Research Center

    Alexandria, Virginia, 22304

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48105

  • Emory University, School of Medicine

    Atlanta, Georgia, 30322

  • Multiple Sclerosis 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

  • The Memory Clinic

    Bennington, Vermont, 05201

  • East Bay Physicians Medical Group

    Berkeley, California, 94705

  • Deaconess Billings Clinical Research Center

    Billings, Montana, 59101

  • University of Alabama Hospital

    Birmingham, Alabama, 35205

  • Brigham and Women's Hospital, Dept. of Neurology

    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

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Neuro-Behavioral Clinical Research, Inc.

    Canton, Ohio, 44718

  • AVI Clinical Research

    Carson, California, 90746

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Medical Research and Health Education Foundation, Inc.

    Columbus, Georgia, 31909

  • Medical Research and Health Education Foundation, Inc

    Columbus, Georgia, 31909

  • Ohio State University, Dept. of Neurology

    Columbus, Ohio, 43210

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Texas Neurology, PA

    Dallas, Texas, 75214

  • University of Texas Southwestern Medical Center, Dept. of Neurology

    Dallas, Texas, 75390

  • Associated Neurologists, PC

    Danbury, Connecticut, 06810

  • Neurology Specialists, Inc.

    Dayton, Ohio, 45417

  • DeKalb Neurology Associates, LLC

    Decatur, Georgia, 30033

  • Quantum Laboratories, Inc.

    Deerfield Beach, Florida, 33064

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • 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

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Neuroscience Institute

    Elk Grove Village, Illinois, 60007

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514

  • Advanced BioBehavioral Sciences

    Elmsford, New York, 10523

  • Pharmacology Research Institute

    Encino, California, 91316

  • Associated Neurologists of Southern Connecticut, P.C.

    Fairfield, Connecticut, 06824

  • Advanced Neurosciences Research, LLC

    Fort Collins, Colorado, 80528

  • Neurologic Consultants, PA

    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 and Memory, PA.

    Fort Walton Beach, Florida, 32547

  • University of North Texas Health Science Center at Fort Worth

    Fort Worth, Texas, 76106

  • Margolin Brain Institute

    Fresno, California, 93720

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Dedicated Clinical Research, Inc.

    Goodyear, Arizona, 85395

  • 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

  • Baylor College of Medicine

    Houston, Texas, 77030

  • 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

  • Borgess Medical Center/Borgess Research Institute

    Kalamazoo, Michigan, 49048

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • 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

    La Jolla, California, 92037

  • Senior Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • Empire Neurology, PC

    Latham, New York, 12110

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • MidAmerica 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 Central New York

    Liverpool, New York, 13088

  • Collaborative NeuroScience Network, Inc.

    Long Beach, California, 90806

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • UCLA Department of Neurology

    Los Angeles, California, 90095

  • Neurology Associates

    Maitland, Florida, 32751

  • Providence Medical Group-Medford Neurology

    Medford, Oregon, 97504

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Pharmax Research Clinic, LLC

    Miami, Florida, 33126

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Allied Clinical Trials Inc.

    Miami, Florida, 33156

  • Miami Research Associates

    Miami, Florida, 33173

  • Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

  • Psychiatric Consultants, PC

    Nashville, Tennessee, 37203

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Parker Jewish Institute for Health Care and Rehabilitation

    New Hyde Park, New York, 11040

  • New York University School of Medicine/Psychiarty

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Christiana Care Neurology Specialists

    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

  • 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

  • Nathan S. Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Four Rivers Clinical Research, Inc.

    Paducah, Kentucky, 42003

  • Palm Beach Neurological Center, Advanced Research Consultants, Inc.

    Palm Beach Gardens, Florida, 33418

  • Neuro-Therapeutics, Inc.

    Pasadena, California, 91105

  • Alzheimer's Research Corporation

    Paterson, New Jersey, 08759

  • 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, PC

    Plymouth, Massachusetts, 02360

  • Neurostudies, Inc.

    Port Charlotte, Florida, 33952

  • Summit Research Group, LLC

    Portland, Oregon, 97223

  • Providence Health Service System, AD Center, Brain Institute

    Portland, Oregon, 97225

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Global Medical Institutes, LLC

    Princeton, New Jersey, 08540

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • 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 at Davis, Alzheimer's Disease Research Center

    Sacramento, California, 95817

  • Washington University School of Medicine

    Saint Lous, Missouri, 63108

  • 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, 94143

  • Neurological Research Institute

    Santa Monica, California, 90404

  • The Roskamp Institute, Inc

    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

  • J. Gary Booker, MD, APMC

    Shreveport, Louisiana, 71104

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794

  • Springfield Neurology Associates, LLC

    Springfield, Massachusetts, 01104

  • Saint Louis University School of Medicine

    St Louis, Missouri, 63104

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33713

  • 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, LLC

    Tampa, Florida, 33613

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

    Tampa, Florida, 33613

  • Shore Neurology, PA

    Toms River, New Jersey, 08755

  • University of Arizona College of Medicine, Health Sciences Center

    Tucson, Arizona, 85724

  • Northwest NeuroSpecialists, PLLC

    Tucson, Arizona, 85741

  • Diablo Clinical Research, Inc

    Walnut Creek, California, 94596

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Independent Psychiatric Consultants

    Waukesha, Wisconsin, 53188

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

Canada14 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

  • Queens University Memorial Clinics

    Kingston, Ontario, K7L 5G2

  • Parkwood Hospital

    London, Ontario, N6C 5J1

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Sir Mortimer B. Davis, Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Neurology Research Inc

    Toronto, Ontario, M3B 2S7

  • Toronto Centre for Memory and Aging

    Toronto, Ontario, M6M 3Z5

  • Douglas Mental Health University Institute

    Verdun, Quebec, H4H 1R3

  • Ontario Shores Centre for Mental Health Sciences

    Whitby, Ontario, L1N 5S9

Other trials in Canada

Austria1 site

  • Landeskrankenhaus- Universitätsklinikum Graz

    Graz, Styria, 8036

Other trials in Austria

About this study

Official title: A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer's Disease Who Participated in Study ELN115727-301 or Study ELN115727-302.

The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.

Being tested
Bapineuzumab
Keywords
Mild to moderate Alzheimer's disease
Medical subject headings
Alzheimer Disease

What participants receive

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

  • BapineuzumabDrug

    0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

    1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

Study groups in NCT00937352
Study groupRoleWhat they receive
Bapineuzumab 0.5 mg/kgActive comparator0.5 mg/kg
Receives: Drug: Bapineuzumab
Bapineuzumab 1.0 mg/kgActive comparator1.0 mg/kg
Receives: Drug: Bapineuzumab

What is being measured

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

  1. Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.

    Measured: Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol

Secondary outcomes (1)

  1. To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.

    Measured: The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first

Timeline

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

  1. First posted13 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionSep 2012
  4. Study completionSep 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
896 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00937352
Sponsor's protocol ID
ELN115727-351
Status last verified
Nov 2013
First submitted
7 Jul 2009
Last updated
20 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bapineuzumab in people with Alzheimer's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 191 sites in 3 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, Canada, 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. 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 was stopped early. Results are not available in the source record.

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?

Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments. (time frame: Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol). 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 NCT00937352.

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 20 Dec 2013.

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