search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bapineuzumab 0.5 mg/kg
Placebo Control
Bapineuzumab 1.0 m/kg
Sponsored by
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University of Alabama Hospital (UAB)
  • Dedicated Clinical Research, Inc.
  • Banner Alzheimer's Institute
  • HOPE Research Institute, LLC
  • Banner Research Institute
  • University of Arizona College of Medicine, Health Sciences Center
  • Northwest NeuroSpecialists, PLLC
  • Clinical Trials Inc.
  • East Bay Physicians Medical Group
  • AVI Clinical Research
  • ATP Clinical Research, Inc
  • Pharmacology Research Institute
  • Margolin Brain Institute
  • Neurology Center of North Orange County
  • Coordinated Clinical Research
  • University of California San Diego
  • Senior Clinical Trials, Inc
  • Collaborative NeuroScience Network, Inc.
  • Pharmacology Research Institute
  • Vintage Institute for Clinical Research, Inc
  • UCLA Department of Neurology
  • Pharmacology Research Institute
  • Neurology Center
  • University of California Irvine Medical Center
  • Neuro-Therapeutics Inc.
  • Sutter Neuroscience Medical Group
  • University of California Davis Alzheimer's Disease Research Center
  • Artemis Institute for Clinical Research
  • Sharp Mesa Vista Hospital
  • San Francisco Clinical Research Center
  • University of California at San Francisco Medical Center at Parnassus
  • Neurological Research Institute
  • Schuster Medical Research Institute
  • Diablo Clinical Research, Inc.
  • Alpine Clinical Research Center
  • Mile High Research Center
  • Advanced Neurosciences Research, LLC
  • Associated Neurologists, PC
  • Associated Neurologists of Southern CT, P.C.
  • Institute for Neurodegenerative Disorders
  • Yale University School of Medicine
  • Research Center for Clinical Studies, Inc
  • Chase Medical Research, LLC
  • Christiana Care Health Services
  • Georgetown University Medical Center
  • JEM Research, LLC
  • Bradenton Research Center, Inc
  • Quantum Laboratories, Inc.
  • Brain Matters Research
  • Neurologic Consultants, P.A.
  • Clinical Physiology Associates, Inc.
  • Emerald Coast Mood & Memory, PA.
  • Neuropsychiatric Research Center of Southwest Florida
  • MD Clinical
  • Mayo Clinic College of Medicine
  • Neurology Associates
  • Melbourne Internal Medicine Associates, MIMA
  • Pharmax Research Clinic, LLC
  • Miami Jewish Health Systems
  • Allied Clinical Trials, Inc.
  • Renstar Medical Research
  • Compass Research, LLC
  • Palm Beach Neurological Center/Advanced Research Consultants
  • Neurostudies, Inc
  • The Roskamp Institute, Inc
  • Miami Research Associates
  • Suncoast Neuroscience Associates, Inc.
  • Meridien Research
  • Axiom Clinical Research of Florida
  • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
  • Stedman Clinical Trials, LLC
  • University of South Florida Suncoast Alzheimer's and Gerontology Center
  • Premiere Research Institute
  • Emory University, School of Medicine
  • Multiple Sclerosis Center of Atlanta
  • NeuroTrials Research, Inc.
  • Medical Research and Health Educational Foundation, Inc
  • DeKalb Neurology Associates, LLC
  • Gwinnett Medical Center
  • University of Chicago Medical Center
  • Alexian Brothers Neurosciences Institute
  • Southern Illinois University, School of Medicine
  • Elkhart Clinic, LLC
  • Indiana University School of Medicine
  • University of Kansas Medical Center
  • Mid America Neuroscience Institute
  • Associates in Neurology, PSC
  • University of Kentucky
  • Four Rivers Clinical Research, Inc
  • Lake Charles Clinical Trials
  • Louisiana State University Health Sciences Center
  • J. Gary Booker, MD, APMC
  • Maine Medical Partners Neurology
  • University of Maryland
  • Johns Hopkins University School of Medicine
  • McLean Hospital
  • Brigham and Women's Hospital
  • Boston University School of Medicine
  • ActivMed Practices and Research, Inc
  • Neurocare, Inc
  • Neuroscience Research of the Berkshires
  • Donald S. Marks, MD, P.C.
  • Springfield Neurology Associates
  • University of Michigan
  • Henry Ford Hospital
  • Michigan State University
  • Saint Mary's Health Care
  • Borgess Medical Center/Borgess Research Institute
  • Mayo Clinic
  • Hattiesburg Clinic
  • Saint Luke's Hospital, Mid America Brain and Stroke Institute
  • The Center for Pharmaceutical Research
  • St. Louis University School of Medicine
  • Washington University School of Medicine
  • Deaconess Billings Clinical Research Center
  • Advanced Neurology Specialists
  • University of Nebraska Medical Center
  • Cleveland Clinic Lou Ruvo Center for Brain Health
  • Memory Enhancement Center of America, Inc.
  • Alzheimer's Research Corporation (ARC)
  • The NeuroCognitive Institute
  • Princeton Medical Institute
  • University of Medicine and Dentistry of New Jersey
  • Albuquerque Neuroscience, Inc.
  • Upstate Clinical Research, LLC
  • Neurological Associates Albany PC
  • Neuroscience Research Center at Albany Medical Center
  • Five Towns Neuroscience Research
  • Advanced BioBehavioral Sciences
  • Empire Neurology, PC
  • Neurological Care of CNY
  • Parker Jewish Institute for Health Care & Rehabilitation
  • NYU School of Medicine/Psychiatry
  • Mt. Sinai School of Medicine
  • Columbia University Medical Center
  • Nathan S. Kline Institute for Psychiatric Research
  • University of Rochester Medical Center @ Monroe Community Hospital
  • Duke University Medical Center
  • Clinical Trials of America, Inc
  • New Hope Clinical Research
  • Raleigh Neurology Associates
  • Wake Forest University Health Sciences
  • University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center
  • Neuro-Behavioral Clinical Research, Inc
  • NeuroCare Center, Inc
  • The Ohio State University
  • Neurology Specialists, Inc.
  • Lynn Health Science Institute
  • Red River Medical Research Center, LLC
  • Providence Medical Group-Medford Neurology
  • Summit Research Group, LLC
  • Providence Health Service System, AD Center, Brain Institute
  • Oregon Health & Sciences University
  • Abington Neurological Assoc
  • Lehigh Valley Health Network
  • The Clinical Trial Center, LLC
  • Drexel University College of Medicine
  • Penn Memory Center
  • Jefferson Hospital for Neuroscience
  • Clinical Trials Research Services, LLC
  • University of Virginia
  • Universtiy of Pittsburgh
  • Rhode Island Mood and Memory Research Institute
  • Rhode Island Hospital
  • Butler Hospital
  • Medical University of South Carolina
  • Avera Research Institute
  • Neurology Clinic, PC
  • Psychiatric Consultants, PC
  • East Tennessee State University
  • Volunteer Research Group
  • Texas Neurology, PA
  • University of North Texas/Health Sciences Center-Fort Worth
  • Baylor College of Medicine
  • Innovative Clinical Trials
  • Integra Clinical Research, LLC
  • Wasatch Clinical Research
  • University of Utah, Dept. of Neurology
  • The Memory Clinic
  • Fletcher Allen Health Care
  • Innovative Clinical Research Center
  • Alliance Research Group, LLC
  • University of Washington Veterans Affairs
  • Pacific Medical Centers
  • University of Wisconsin School of Medicine and Public Health
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Bapineuzumab 0.5 mg/kg

Placebo Dose

Bapineuzumab 1.0 m/kg

Arm Description

infusion every 13 weeks for a total of 6 infusions

infusion every 13 weeks for a total of 6 infusions.

infusion every 13 weeks for a total of 6 infusions.

Outcomes

Primary Outcome Measures

Cognitive and Functional

Secondary Outcome Measures

Cognitive and Global
Imaging and biochemical biomarkers of disease status

Full Information

First Posted
December 10, 2007
Last Updated
October 30, 2013
Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00575055
Brief Title
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)
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 Carriers.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bapineuzumab 0.5 mg/kg
Arm Type
Experimental
Arm Description
infusion every 13 weeks for a total of 6 infusions
Arm Title
Placebo Dose
Arm Type
Placebo Comparator
Arm Description
infusion every 13 weeks for a total of 6 infusions.
Arm Title
Bapineuzumab 1.0 m/kg
Arm Type
Experimental
Arm Description
infusion every 13 weeks for a total of 6 infusions.
Intervention Type
Drug
Intervention Name(s)
Bapineuzumab 0.5 mg/kg
Other Intervention Name(s)
AAB-001
Intervention Description
given by infusion every 13 weeks for a total of 6 infusions.
Intervention Type
Drug
Intervention Name(s)
Placebo Control
Intervention Description
given by infusion every 13 weeks for a total of 6 infusions.
Intervention Type
Drug
Intervention Name(s)
Bapineuzumab 1.0 m/kg
Other Intervention Name(s)
AAB-001
Intervention Description
given by infusion every 13 weeks for a total of 6 infusions.
Primary Outcome Measure Information:
Title
Cognitive and Functional
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Cognitive and Global
Time Frame
18 months
Title
Imaging and biochemical biomarkers of disease status
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Facility Information:
Facility Name
University of Alabama Hospital (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Dedicated Clinical Research, Inc.
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
HOPE Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Banner Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
University of Arizona College of Medicine, Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Northwest NeuroSpecialists, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Clinical Trials Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
East Bay Physicians Medical Group
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
AVI Clinical Research
City
Carson
State/Province
California
ZIP/Postal Code
90746
Country
United States
Facility Name
ATP Clinical Research, Inc
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Coordinated Clinical Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Senior Clinical Trials, Inc
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Collaborative NeuroScience Network, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Vintage Institute for Clinical Research, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
UCLA Department of Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Neurology Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Neuro-Therapeutics Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Sutter Neuroscience Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Alzheimer's Disease Research Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
University of California at San Francisco Medical Center at Parnassus
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Advanced Neurosciences Research, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Associated Neurologists, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Associated Neurologists of Southern CT, P.C.
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Research Center for Clinical Studies, Inc
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
JEM Research, LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Bradenton Research Center, Inc
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Quantum Laboratories, Inc.
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Neurologic Consultants, P.A.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Clinical Physiology Associates, Inc.
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Emerald Coast Mood & Memory, PA.
City
Fort Walton Beach
State/Province
Florida
ZIP/Postal Code
32547
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Mayo Clinic College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Neurology Associates
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Melbourne Internal Medicine Associates, MIMA
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Pharmax Research Clinic, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Allied Clinical Trials, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Palm Beach Neurological Center/Advanced Research Consultants
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
Facility Name
Neurostudies, Inc
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
The Roskamp Institute, Inc
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc.
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University of South Florida Suncoast Alzheimer's and Gerontology Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Emory University, School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Multiple Sclerosis Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Medical Research and Health Educational Foundation, Inc
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
DeKalb Neurology Associates, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gwinnett Medical Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Alexian Brothers Neurosciences Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Southern Illinois University, School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
Elkhart Clinic, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Mid America Neuroscience Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Associates in Neurology, PSC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Four Rivers Clinical Research, Inc
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
J. Gary Booker, MD, APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Maine Medical Partners Neurology
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
ActivMed Practices and Research, Inc
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Neurocare, Inc
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Neuroscience Research of the Berkshires
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Donald S. Marks, MD, P.C.
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Springfield Neurology Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Saint Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Borgess Medical Center/Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Saint Luke's Hospital, Mid America Brain and Stroke Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
St. Louis University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Deaconess Billings Clinical Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Advanced Neurology Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2045
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Alzheimer's Research Corporation (ARC)
City
Manchester
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
Facility Name
The NeuroCognitive Institute
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Neurological Associates Albany PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Neuroscience Research Center at Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Five Towns Neuroscience Research
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Advanced BioBehavioral Sciences
City
Elmsford
State/Province
New York
ZIP/Postal Code
10523
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
Neurological Care of CNY
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Parker Jewish Institute for Health Care & Rehabilitation
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU School of Medicine/Psychiatry
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mt. Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Nathan S. Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
University of Rochester Medical Center @ Monroe Community Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Clinical Trials of America, Inc
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
New Hope Clinical Research
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
NeuroCare Center, Inc
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology Specialists, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Red River Medical Research Center, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Providence Medical Group-Medford Neurology
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Summit Research Group, LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Providence Health Service System, AD Center, Brain Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Abington Neurological Assoc
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Penn Memory Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Jefferson Hospital for Neuroscience
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
University of Virginia
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Universtiy of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Mood and Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina
City
N. Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Neurology Clinic, PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Psychiatric Consultants, PC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614-1707
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Texas Neurology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
University of North Texas/Health Sciences Center-Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76106
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Innovative Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Integra Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah, Dept. of Neurology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Innovative Clinical Research Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Alliance Research Group, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
University of Washington Veterans Affairs
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Pacific Medical Centers
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30412493
Citation
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.
Results Reference
derived
PubMed Identifier
28269765
Citation
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.
Results Reference
derived
PubMed Identifier
29854935
Citation
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.
Results Reference
derived
PubMed Identifier
26208959
Citation
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.
Results Reference
derived
PubMed Identifier
29854934
Citation
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.
Results Reference
derived
PubMed Identifier
24450891
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs