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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).
The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods.
This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient's participation will last approximately 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.15 mg/kg active bapineuzumab | Experimental |
| |
| 0.15 mg/kg placebo | Placebo Comparator |
| |
| 0.5 mg/kg active bapineuzumab | Experimental |
| |
| 0.5 mg/kg placebo | Placebo Comparator |
| |
| 1.0 mg/kg active bapineuzumab | Experimental |
| |
| 1.0 mg/kg placebo | Placebo Comparator |
| |
| 2.0 mg/kg active bapineuzumab | Experimental |
| |
| 2.0 mg/kg placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bapineuzumab | Drug | IV, Q13w |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety assessments | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| blood levels of administered study drug | 18 months | |
| cognitive and functional assessments | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleo Roberts Center for Clinical Research / Sun Health Research Institute | Sun City | Arizona | 85351 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 22473769 |
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|
|
| placebo | Other | IV Q13w |
|
| UC Irvine |
| Irvine |
| California |
| 92697 |
| United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| Pharmacology Research Institute | Northridge | California | 91324 | United States |
| UCSD Shiley-Marcos Alzheimer's Disease Research Center | San Diego | California | United States |
| Memory & Aging Center, UCSF | San Francisco | California | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20057 | United States |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | United States |
| Mayo Clinic - Department of Neurology | Jacksonville | Florida | 32224 | United States |
| Rush Presbyterian St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Department of Neurology - Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States |
| Behavioral Neurology | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health System, Department of Neurology | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center | Rochester | Minnesota | 55905 | United States |
| The Memory Enhancement Center | Long Branch | New Jersey | 07740 | United States |
| Sergievsky Center, Columbia University | New York | New York | 10032 | United States |
| University of Rochester / Monroe Community Hospital | Rochester | New York | 14620 | United States |
| Department of Psychiatry and Behavioral Sciences | Durham | North Carolina | 27710 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Memory and Aging Program, Butler Hospital | Providence | Rhode Island | 02906 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Clinical Neuroscience Research Associates, Inc. | Bennington | Vermont | 05201 | United States |
| University of Washington | Seattle | Washington | 98108 | United States |
| Derived |
| Blennow K, Zetterberg H, Rinne JO, Salloway S, Wei J, Black R, Grundman M, Liu E; AAB-001 201/202 Investigators. Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Arch Neurol. 2012 Aug;69(8):1002-10. doi: 10.1001/archneurol.2012.90. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| 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 |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C545458 | bapineuzumab |
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