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This is a multicenter, open-label, long-term extension study in male and female patients with mild to moderate Alzheimer's Disease (AD) who must have completed one of the following studies: AAB-001-201 or AAB-001-102. All patients enrolled in Study AAB-001-251 will receive infusions of AAB-001 (bapineuzumab), including patients randomized to placebo in Study 201 and 102. Approximately 30 study sites in the US will be involved. Each patient's participation may vary from 3 months up to 84 months depending on the date of enrollment in this study.
AAB-001 (bapineuzumab) is a humanized monoclonal antibody, which binds to and potentially clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 0.15 mg/kg active bapineuzumab |
|
| 2 | Active Comparator | 0.5 mg/kg active bapineuzumab |
|
| 3 | Active Comparator | 1.0 mg/kg active bapineuzmab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bapineuzumab (AAB-001) | Drug | IV q13w |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of long-term treatment of bapineuzumab in subjects with AD. |
| 3-84 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of long-term treatment of bapineuzumab in subjects with AD. | Change from Visit 2 (Pre-Day 1) and Visit 22 (Week 78) of Study AAB-001-201 for the following scales:
Change from Study AAB-001-251Visit 1 (Day 1) for the following scales:
Change from Study 251 Screening Visit for the following scales for subjects entering from Study AAB-001-102 (US):
|
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Inclusion Criteria:
A subject must meet ALL of the following criteria to be considered for enrollment into this study:
Exclusion Criteria:
ANY one of the following will exclude a subject from being enrolled into the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Janssen AI Investigational Site | Peoria | Arizona | 85381 | United States | ||
| Janssen AI Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30129411 | Derived | Salloway S, Marshall GA, Lu M, Brashear HR. Long-Term Safety and Efficacy of Bapineuzumab in Patients with Mild-to-Moderate Alzheimer's Disease: A Phase 2, Open-Label Extension Study. Curr Alzheimer Res. 2018;15(13):1231-1243. doi: 10.2174/1567205015666180821114813. | |
| 25669746 | Derived | Arrighi HM, Barakos J, Barkhof F, Tampieri D, Jack C Jr, Melancon D, Morris K, Ketter N, Liu E, Brashear HR. Amyloid-related imaging abnormalities-haemosiderin (ARIA-H) in patients with Alzheimer's disease treated with bapineuzumab: a historical, prospective secondary analysis. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):106-12. doi: 10.1136/jnnp-2014-309493. Epub 2015 Feb 10. |
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| 3-84 months |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Janssen AI Investigational Site | Encino | California | 91316 | United States |
| Janssen AI Investigational Site | Irvine | California | 92697 | United States |
| Janssen AI Investigational Site | La Jolla | California | 92037 | United States |
| Janssen AI Investigational Site | Los Alamitos | California | 90720 | United States |
| Janssen AI Investigational Site | Sacramento | California | 95817 | United States |
| Janssen AI Investigational Site | San Francisco | California | 94143 | United States |
| Janssen AI Investigational Site | New Haven | Connecticut | 06510 | United States |
| Janssen AI Investigational Site | Washington D.C. | District of Columbia | 20057 | United States |
| Janssen AI Investigational Site | Delray Beach | Florida | 33445 | United States |
| Janssen AI Investigational Site | Jacksonville | Florida | 32224 | United States |
| Janssen AI Investigational Site | Chicago | Illinois | 60612 | United States |
| Janssen AI Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Janssen AI Investigational Site | Boston | Massachusetts | 02115 | United States |
| Janssen AI Investigational Site | Ann Arbor | Michigan | 48105 | United States |
| Janssen AI Investigational Site | Rochester | Minnesota | 55905 | United States |
| Janssen AI Investigational Site | St Louis | Missouri | 63108 | United States |
| Janssen AI Investigational Site | Eatontown | New Jersey | 07724 | United States |
| Janssen AI Investigational Site | New York | New York | 10032 | United States |
| Janssen AI Investigational Site | Rochester | New York | 14620 | United States |
| Janssen AI Investigational Site | Durham | North Carolina | 27710 | United States |
| Janssen AI Investigational Site | Portland | Oregon | 97239 | United States |
| Janssen AI Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Janssen AI Investigational Site | Providence | Rhode Island | 02906 | United States |
| Janssen AI Investigational Site | Dallas | Texas | 75390 | United States |
| Janssen AI Investigational Site | Houstan | Texas | 77030 | United States |
| Janssen AI Investigational Site | Bennington | Vermont | 05201 | United States |
| Janssen AI Investigational Site | Seattle | Washington | 98108 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C545458 | bapineuzumab |
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