Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)
Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00575055
Collaborator
Pfizer (Industry)
1,121
186
3
52
6
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date
:
Dec 1, 2007
Actual Primary Completion Date
:
Apr 1, 2012
Actual Study Completion Date
:
Apr 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bapineuzumab 0.5 mg/kg infusion every 13 weeks for a total of 6 infusions |
Drug: Bapineuzumab 0.5 mg/kg
given by infusion every 13 weeks for a total of 6 infusions.
Other Names:
|
| Placebo Comparator: Placebo Dose infusion every 13 weeks for a total of 6 infusions. |
Drug: Placebo Control
given by infusion every 13 weeks for a total of 6 infusions.
|
| Experimental: Bapineuzumab 1.0 m/kg infusion every 13 weeks for a total of 6 infusions. |
Drug: Bapineuzumab 1.0 m/kg
given by infusion every 13 weeks for a total of 6 infusions.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cognitive and Functional [18 months]
Secondary Outcome Measures
- Cognitive and Global [18 months]
- Imaging and biochemical biomarkers of disease status [18 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 88 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Hospital (UAB) | Birmingham | Alabama | United States | 35205 |
| 2 | Dedicated Clinical Research, Inc. | Goodyear | Arizona | United States | 85395 |
| 3 | Banner Alzheimer's Institute | Phoenix | Arizona | United States | 85006 |
| 4 | HOPE Research Institute, LLC | Phoenix | Arizona | United States | 85050 |
| 5 | Banner Research Institute | Sun City | Arizona | United States | 85351 |
| 6 | University of Arizona College of Medicine, Health Sciences Center | Tucson | Arizona | United States | 85724 |
| 7 | Northwest NeuroSpecialists, PLLC | Tucson | Arizona | United States | 85741 |
| 8 | Clinical Trials Inc. | Little Rock | Arkansas | United States | 72205 |
| 9 | East Bay Physicians Medical Group | Berkeley | California | United States | 94705 |
| 10 | AVI Clinical Research | Carson | California | United States | 90746 |
| 11 | ATP Clinical Research, Inc | Costa Mesa | California | United States | 92626 |
| 12 | Pharmacology Research Institute | Encino | California | United States | 91316 |
| 13 | Margolin Brain Institute | Fresno | California | United States | 93720 |
| 14 | Neurology Center of North Orange County | Fullerton | California | United States | 92835 |
| 15 | Coordinated Clinical Research | La Jolla | California | United States | 92037 |
| 16 | University of California San Diego | La Jolla | California | United States | 92037 |
| 17 | Senior Clinical Trials, Inc | Laguna Hills | California | United States | 92653 |
| 18 | Collaborative NeuroScience Network, Inc. | Long Beach | California | United States | 90806 |
| 19 | Pharmacology Research Institute | Los Alamitos | California | United States | 90720 |
| 20 | Vintage Institute for Clinical Research, Inc | Los Angeles | California | United States | 90035 |
| 21 | UCLA Department of Neurology | Los Angeles | California | United States | 90095 |
| 22 | Pharmacology Research Institute | Newport Beach | California | United States | 92660 |
| 23 | Neurology Center | Oceanside | California | United States | 92056 |
| 24 | University of California Irvine Medical Center | Orange | California | United States | 92868 |
| 25 | Neuro-Therapeutics Inc. | Pasadena | California | United States | 91105 |
| 26 | Sutter Neuroscience Medical Group | Sacramento | California | United States | 95816 |
| 27 | University of California Davis Alzheimer's Disease Research Center | Sacramento | California | United States | 95817 |
| 28 | Artemis Institute for Clinical Research | San Diego | California | United States | 92123 |
| 29 | Sharp Mesa Vista Hospital | San Diego | California | United States | 92123 |
| 30 | San Francisco Clinical Research Center | San Francisco | California | United States | 94109 |
| 31 | University of California at San Francisco Medical Center at Parnassus | San Francisco | California | United States | 94117 |
| 32 | Neurological Research Institute | Santa Monica | California | United States | 90404 |
| 33 | Schuster Medical Research Institute | Sherman Oaks | California | United States | 91403 |
| 34 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
| 35 | Alpine Clinical Research Center | Boulder | Colorado | United States | 80304 |
| 36 | Mile High Research Center | Denver | Colorado | United States | 80218 |
| 37 | Advanced Neurosciences Research, LLC | Fort Collins | Colorado | United States | 80528 |
| 38 | Associated Neurologists, PC | Danbury | Connecticut | United States | 06810 |
| 39 | Associated Neurologists of Southern CT, P.C. | Fairfield | Connecticut | United States | 06824 |
| 40 | Institute for Neurodegenerative Disorders | New Haven | Connecticut | United States | 06510 |
| 41 | Yale University School of Medicine | New Haven | Connecticut | United States | 06510 |
| 42 | Research Center for Clinical Studies, Inc | Norwalk | Connecticut | United States | 06851 |
| 43 | Chase Medical Research, LLC | Waterbury | Connecticut | United States | 06708 |
| 44 | Christiana Care Health Services | Newark | Delaware | United States | 19713 |
| 45 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20057 |
| 46 | JEM Research, LLC | Atlantis | Florida | United States | 33462 |
| 47 | Bradenton Research Center, Inc | Bradenton | Florida | United States | 34205 |
| 48 | Quantum Laboratories, Inc. | Deerfield Beach | Florida | United States | 33064 |
| 49 | Brain Matters Research | Delray Beach | Florida | United States | 33445 |
| 50 | Neurologic Consultants, P.A. | Fort Lauderdale | Florida | United States | 33308 |
| 51 | Clinical Physiology Associates, Inc. | Fort Myers | Florida | United States | 33916 |
| 52 | Emerald Coast Mood & Memory, PA. | Fort Walton Beach | Florida | United States | 32547 |
| 53 | Neuropsychiatric Research Center of Southwest Florida | Ft. Myers | Florida | United States | 33912 |
| 54 | MD Clinical | Hallandale Beach | Florida | United States | 33009 |
| 55 | Mayo Clinic College of Medicine | Jacksonville | Florida | United States | 32224 |
| 56 | Neurology Associates | Maitland | Florida | United States | 32751 |
| 57 | Melbourne Internal Medicine Associates, MIMA | Melbourne | Florida | United States | 32901 |
| 58 | Pharmax Research Clinic, LLC | Miami | Florida | United States | 33126 |
| 59 | Miami Jewish Health Systems | Miami | Florida | United States | 33137 |
| 60 | Allied Clinical Trials, Inc. | Miami | Florida | United States | 33156 |
| 61 | Renstar Medical Research | Ocala | Florida | United States | 34471 |
| 62 | Compass Research, LLC | Orlando | Florida | United States | 32806 |
| 63 | Palm Beach Neurological Center/Advanced Research Consultants | Palm Beach Gardens | Florida | United States | 33418 |
| 64 | Neurostudies, Inc | Port Charlotte | Florida | United States | 33952 |
| 65 | The Roskamp Institute, Inc | Sarasota | Florida | United States | 34243 |
| 66 | Miami Research Associates | South Miami | Florida | United States | 33143 |
| 67 | Suncoast Neuroscience Associates, Inc. | St Petersburg | Florida | United States | 33713 |
| 68 | Meridien Research | St. Petersburg | Florida | United States | 33709 |
| 69 | Axiom Clinical Research of Florida | Tampa | Florida | United States | 33609 |
| 70 | Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute | Tampa | Florida | United States | 33613 |
| 71 | Stedman Clinical Trials, LLC | Tampa | Florida | United States | 33613 |
| 72 | University of South Florida Suncoast Alzheimer's and Gerontology Center | Tampa | Florida | United States | 33613 |
| 73 | Premiere Research Institute | West Palm Beach | Florida | United States | 33407 |
| 74 | Emory University, School of Medicine | Atlanta | Georgia | United States | 30322 |
| 75 | Multiple Sclerosis Center of Atlanta | Atlanta | Georgia | United States | 30327 |
| 76 | NeuroTrials Research, Inc. | Atlanta | Georgia | United States | 30342 |
| 77 | Medical Research and Health Educational Foundation, Inc | Columbus | Georgia | United States | 31909 |
| 78 | DeKalb Neurology Associates, LLC | Decatur | Georgia | United States | 30033 |
| 79 | Gwinnett Medical Center | Lawrenceville | Georgia | United States | 30045 |
| 80 | University of Chicago Medical Center | Chicago | Illinois | United States | 60637 |
| 81 | Alexian Brothers Neurosciences Institute | Elk Grove Village | Illinois | United States | 60007 |
| 82 | Southern Illinois University, School of Medicine | Springfield | Illinois | United States | 62794 |
| 83 | Elkhart Clinic, LLC | Elkhart | Indiana | United States | 46514 |
| 84 | Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
| 85 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 86 | Mid America Neuroscience Institute | Lenexa | Kansas | United States | 66214 |
| 87 | Associates in Neurology, PSC | Lexington | Kentucky | United States | 40513 |
| 88 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
| 89 | Four Rivers Clinical Research, Inc | Paducah | Kentucky | United States | 42003 |
| 90 | Lake Charles Clinical Trials | Lake Charles | Louisiana | United States | 70629 |
| 91 | Louisiana State University Health Sciences Center | Shreveport | Louisiana | United States | 70112 |
| 92 | J. Gary Booker, MD, APMC | Shreveport | Louisiana | United States | 71104 |
| 93 | Maine Medical Partners Neurology | Scarborough | Maine | United States | 04074 |
| 94 | University of Maryland | Baltimore | Maryland | United States | 21201 |
| 95 | Johns Hopkins University School of Medicine | Baltimore | Maryland | United States | 21224 |
| 96 | McLean Hospital | Belmont | Massachusetts | United States | 02478 |
| 97 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 98 | Boston University School of Medicine | Boston | Massachusetts | United States | 02118 |
| 99 | ActivMed Practices and Research, Inc | Haverhill | Massachusetts | United States | 01830 |
| 100 | Neurocare, Inc | Newton | Massachusetts | United States | 02459 |
| 101 | Neuroscience Research of the Berkshires | Pittsfield | Massachusetts | United States | 01201 |
| 102 | Donald S. Marks, MD, P.C. | Plymouth | Massachusetts | United States | 02360 |
| 103 | Springfield Neurology Associates | Springfield | Massachusetts | United States | 01104 |
| 104 | University of Michigan | Ann Arbor | Michigan | United States | 48105 |
| 105 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 106 | Michigan State University | East Lansing | Michigan | United States | 48824 |
| 107 | Saint Mary's Health Care | Grand Rapids | Michigan | United States | 49503 |
| 108 | Borgess Medical Center/Borgess Research Institute | Kalamazoo | Michigan | United States | 49048 |
| 109 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 110 | Hattiesburg Clinic | Hattiesburg | Mississippi | United States | 39401 |
| 111 | Saint Luke's Hospital, Mid America Brain and Stroke Institute | Kansas City | Missouri | United States | 64111 |
| 112 | The Center for Pharmaceutical Research | Kansas City | Missouri | United States | 64114 |
| 113 | St. Louis University School of Medicine | St. Louis | Missouri | United States | 63104 |
| 114 | Washington University School of Medicine | St. Louis | Missouri | United States | 63108 |
| 115 | Deaconess Billings Clinical Research Center | Billings | Montana | United States | 59101 |
| 116 | Advanced Neurology Specialists | Great Falls | Montana | United States | 59405 |
| 117 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-2045 |
| 118 | Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | United States | 89106 |
| 119 | Memory Enhancement Center of America, Inc. | Eatontown | New Jersey | United States | 07724 |
| 120 | Alzheimer's Research Corporation (ARC) | Manchester | New Jersey | United States | 08759 |
| 121 | The NeuroCognitive Institute | Mount Arlington | New Jersey | United States | 07856 |
| 122 | Princeton Medical Institute | Princeton | New Jersey | United States | 08540 |
| 123 | University of Medicine and Dentistry of New Jersey | Stratford | New Jersey | United States | 08084 |
| 124 | Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | United States | 87109 |
| 125 | Upstate Clinical Research, LLC | Albany | New York | United States | 12205 |
| 126 | Neurological Associates Albany PC | Albany | New York | United States | 12208 |
| 127 | Neuroscience Research Center at Albany Medical Center | Albany | New York | United States | 12208 |
| 128 | Five Towns Neuroscience Research | Cedarhurst | New York | United States | 11516 |
| 129 | Advanced BioBehavioral Sciences | Elmsford | New York | United States | 10523 |
| 130 | Empire Neurology, PC | Latham | New York | United States | 12110 |
| 131 | Neurological Care of CNY | Liverpool | New York | United States | 13088 |
| 132 | Parker Jewish Institute for Health Care & Rehabilitation | New Hyde Park | New York | United States | 11040 |
| 133 | NYU School of Medicine/Psychiatry | New York | New York | United States | 10016 |
| 134 | Mt. Sinai School of Medicine | New York | New York | United States | 10029 |
| 135 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 136 | Nathan S. Kline Institute for Psychiatric Research | Orangeburg | New York | United States | 10962 |
| 137 | University of Rochester Medical Center @ Monroe Community Hospital | Rochester | New York | United States | 14620 |
| 138 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 139 | Clinical Trials of America, Inc | Hickory | North Carolina | United States | 28601 |
| 140 | New Hope Clinical Research | Hickory | North Carolina | United States | 28601 |
| 141 | Raleigh Neurology Associates | Raleigh | North Carolina | United States | 27607 |
| 142 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 143 | University Hospitals of Cleveland, Case Medical Center, Memory and Cognition Center | Beachwood | Ohio | United States | 44122 |
| 144 | Neuro-Behavioral Clinical Research, Inc | Canton | Ohio | United States | 44718 |
| 145 | NeuroCare Center, Inc | Canton | Ohio | United States | 44718 |
| 146 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 147 | Neurology Specialists, Inc. | Dayton | Ohio | United States | 45417 |
| 148 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
| 149 | Red River Medical Research Center, LLC | Oklahoma City | Oklahoma | United States | 73112 |
| 150 | Providence Medical Group-Medford Neurology | Medford | Oregon | United States | 97504 |
| 151 | Summit Research Group, LLC | Portland | Oregon | United States | 97210 |
| 152 | Providence Health Service System, AD Center, Brain Institute | Portland | Oregon | United States | 97225 |
| 153 | Oregon Health & Sciences University | Portland | Oregon | United States | 97239 |
| 154 | Abington Neurological Assoc | Abington | Pennsylvania | United States | 19001 |
| 155 | Lehigh Valley Health Network | Allentown | Pennsylvania | United States | 18103 |
| 156 | The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | United States | 19046 |
| 157 | Drexel University College of Medicine | Philadelphia | Pennsylvania | United States | 19102 |
| 158 | Penn Memory Center | Philadelphia | Pennsylvania | United States | 19104 |
| 159 | Jefferson Hospital for Neuroscience | Philadelphia | Pennsylvania | United States | 19107 |
| 160 | Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | United States | 15206 |
| 161 | University of Virginia | Pittsburgh | Pennsylvania | United States | 15213 |
| 162 | Universtiy of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
| 163 | Rhode Island Mood and Memory Research Institute | East Providence | Rhode Island | United States | 02914 |
| 164 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 165 | Butler Hospital | Providence | Rhode Island | United States | 02906 |
| 166 | Medical University of South Carolina | N. Charleston | South Carolina | United States | 29406 |
| 167 | Avera Research Institute | Sioux Falls | South Dakota | United States | 57105 |
| 168 | Neurology Clinic, PC | Cordova | Tennessee | United States | 38018 |
| 169 | Psychiatric Consultants, PC | Franklin | Tennessee | United States | 37067 |
| 170 | East Tennessee State University | Johnson City | Tennessee | United States | 37614-1707 |
| 171 | Volunteer Research Group | Knoxville | Tennessee | United States | 37920 |
| 172 | Texas Neurology, PA | Dallas | Texas | United States | 75214 |
| 173 | University of North Texas/Health Sciences Center-Fort Worth | Fort Worth | Texas | United States | 76106 |
| 174 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 175 | Innovative Clinical Trials | San Antonio | Texas | United States | 78229 |
| 176 | Integra Clinical Research, LLC | San Antonio | Texas | United States | 78231 |
| 177 | Wasatch Clinical Research | Salt Lake City | Utah | United States | 84107 |
| 178 | University of Utah, Dept. of Neurology | Salt Lake City | Utah | United States | 84108 |
| 179 | The Memory Clinic | Bennington | Vermont | United States | 05201 |
| 180 | Fletcher Allen Health Care | Burlington | Vermont | United States | 05401 |
| 181 | Innovative Clinical Research Center | Alexandria | Virginia | United States | 22304 |
| 182 | Alliance Research Group, LLC | Richmond | Virginia | United States | 23230 |
| 183 | University of Washington Veterans Affairs | Seattle | Washington | United States | 98108 |
| 184 | Pacific Medical Centers | Seattle | Washington | United States | 98144 |
| 185 | University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | United States | 53705 |
| 186 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Pfizer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00575055
Other Study ID Numbers:
- ELN115727-302
First Posted:
Dec 17, 2007
Last Update Posted:
Nov 25, 2013
Last Verified:
Oct 1, 2013
Additional relevant MeSH terms: