Alzheimer's DiseasePhase 3NCT00575055
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 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 186 sites in United States.
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 200 study sites in the US and Canada 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
- 1,121 participants
- Where
- 186 sitesUnited States
- Study dates
- Dec 2007to Apr 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
186 sites in 1 country.
186 sites in 1 country
United States186 sites
Abington Neurological Assoc
Abington, Pennsylvania, 19001
Upstate Clinical Research, LLC
Albany, New York, 12205
Neurological Associates 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
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
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center
Beachwood, Ohio, 44122
McLean Hospital
Belmont, Massachusetts, 02478
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 (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
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 Chicago Medical Center
Chicago, Illinois, 60637
Medical Research and Health Educational Foundation, Inc
Columbus, Georgia, 31909
The 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
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
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 Neurosciences 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 CT, P.C.
Fairfield, Connecticut, 06824
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
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
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
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, 37614-1707
Borgess Medical Center/Borgess Research Institute
Kalamazoo, Michigan, 49048
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
La Jolla, California, 92037
Senior Clinical Trials, Inc
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
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, Inc.
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 Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
Neurology Associates
Maitland, Florida, 32751
Providence Medical Group-Medford Neurology
Medford, Oregon, 97504
Melbourne Internal 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
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Yale University School of Medicine
New Haven, Connecticut, 06510
Parker Jewish Institute for Health Care & Rehabilitation
New Hyde Park, New York, 11040
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
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
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, 68198-2045
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
Palm Beach Gardens, Florida, 33418
Neuro-Therapeutics Inc.
Pasadena, California, 91105
Alzheimer's Research Corporation (ARC)
Paterson, New Jersey, 08759
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 Virginia
Pittsburgh, Pennsylvania, 15213
Universtiy 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, LLC
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
Alliance Research Group, LLC
Richmond, Virginia, 23230
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical Center @ Monroe Community Hospital
Rochester, New York, 14620
Sutter Neuroscience Medical Group
Sacramento, California, 95816
University of California Davis Alzheimer's Disease Research 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 at San Francisco Medical Center at Parnassus
San Francisco, California, 94117
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
Louisiana 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
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, LLC
Tampa, Florida, 33613
University of South Florida Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, 33613
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, 94598
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Premiere Research Institute
West Palm Beach, Florida, 33407
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
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 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 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.
- Conditions
- Alzheimer's Disease
- 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
given by 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
given by infusion every 13 weeks for a total of 6 infusions.
| Study group | Role | What they receive |
|---|---|---|
| Bapineuzumab 0.5 mg/kg | Experimental | infusion every 13 weeks for a total of 6 infusions Receives: Drug: Bapineuzumab 0.5 mg/kg |
| Placebo Dose | Placebo comparator | infusion every 13 weeks for a total of 6 infusions. Receives: Drug: Placebo Control |
| Bapineuzumab 1.0 m/kg | Experimental | infusion 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.
Cognitive and Functional
Measured: 18 months
Secondary outcomes (2)
Cognitive and Global
Measured: 18 months
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.
- First posted17 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575055
- Sponsor's protocol ID
- ELN115727-302
- 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 30412493Samtani 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 29854935Xu 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 29854934Ketter 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 28269765Liu 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 26208959Salloway 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00575055
- Acronym / sponsor ID
- ELN115727-302
- Conditions
- Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,121 participants (actual)
- Lead sponsor
- JANSSEN Alzheimer Immunotherapy Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Dec 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bapineuzumab 0.5 mg/kg | Experimental | Drug: Bapineuzumab 0.5 mg/kginfusion every 13 weeks for a total of 6 infusions |
| Placebo Dose | Placebo comparator | Drug: Placebo Controlinfusion every 13 weeks for a total of 6 infusions. |
| Bapineuzumab 1.0 m/kg | Experimental | Drug: Bapineuzumab 1.0 m/kginfusion every 13 weeks for a total of 6 infusions. |
Who may qualify
- Ages
- 50 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bapineuzumab 0.5 mg/kgAlso: AAB-001given by infusion every 13 weeks for a total of 6 infusions. | Drug | Bapineuzumab 0.5 mg/kg |
| Placebo Controlgiven by infusion every 13 weeks for a total of 6 infusions. | Drug | Placebo Dose |
| Bapineuzumab 1.0 m/kgAlso: AAB-001given by infusion every 13 weeks for a total of 6 infusions. | Drug | Bapineuzumab 1.0 m/kg |
Primary outcome
Cognitive and Functional
Time frame: 18 months
2 secondary outcomes
Cognitive and Global
Time frame: 18 months
Imaging and biochemical biomarkers of disease status
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 30412493Brashear 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.
- Derived from this study: PubMed 29854935Samtani 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.
- Derived from this study: PubMed 29854934Xu 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.
- Derived from this study: PubMed 28269765Ketter 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.
- Derived from this study: PubMed 26208959Liu 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.
- Derived from this study: PubMed 24450891Salloway 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
186 sites in 1 country: see every site and its status.
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 186 sites in United States.
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 186 sites in United States. 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 NCT00575055, 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.