AAB-001 (Bapineuzumab) Open-Label, Long-Term Extension Study in Patients With Mild to Moderate Alzheimer's Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00606476 |
Recruitment Status :
Terminated
First Posted : February 4, 2008
Last Update Posted : November 25, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: Bapineuzumab (AAB-001) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 194 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | A Phase II, Multicenter, Open-Label, Long-Term Treatment Study to Determine the Safety, Tolerability, and Efficacy of Bapineuzumab (AAB-001) in Patients With Alzheimer's Disease Who Participated in Study AAB-001-201 or AAB-001-102 |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
0.15 mg/kg active bapineuzumab
|
Drug: Bapineuzumab (AAB-001)
IV q13w
Other Name: AAB-001 |
Active Comparator: 2
0.5 mg/kg active bapineuzumab
|
Drug: Bapineuzumab (AAB-001)
IV q13w
Other Name: AAB-001 |
Active Comparator: 3
1.0 mg/kg active bapineuzmab
|
Drug: Bapineuzumab (AAB-001)
IV q13w
Other Name: AAB-001 |
- To assess the safety and tolerability of long-term treatment of bapineuzumab in subjects with AD. [ Time Frame: 3-84 months ]
- The incidence and severity of treatment-emergent adverse events (TEAEs);
- Clinically important changes in safety assessment results (including, as appropriate, vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], brain magnetic resonance imaging [MRIs], physical and neurological examinations, and infusion site assessments).
- To evaluate the efficacy of long-term treatment of bapineuzumab in subjects with AD. [ Time Frame: 3-84 months ]
Change from Visit 2 (Pre-Day 1) and Visit 22 (Week 78) of Study AAB-001-201 for the following scales:
- Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog)
- Disability Assessment for Dementia (DAD)
- Mini Mental State Examination (MMSE)
Change from Study AAB-001-251Visit 1 (Day 1) for the following scales:
- Dependence Scale
- Resource Utilization in Dementia (RUD) Lite
Change from Study 251 Screening Visit for the following scales for subjects entering from Study AAB-001-102 (US):
- ADAS-Cog
- DAD
- MMSE

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject must meet ALL of the following criteria to be considered for enrollment into this study:
- Signed and dated written informed consent obtained from the subject and/or the subject's caregiver in accordance with the local regulations.
- Subjects must have completed Study 201 Visit 22 (Week 78), or Study 102 Visit 11 (Week 16).
- Magnetic resonance imaging scan of sufficient quality for the Radiologist to evaluate subject safety from Study 201 Visit 21 (Week 71), or Study 251 Screening Visit for subjects from Study 102.
- Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately five times per week for the duration of the study.
- In the opinion of the investigator, the subject and the caregiver will be compliant.
Exclusion Criteria:
ANY one of the following will exclude a subject from being enrolled into the study:
- Significant neurological disease other than AD that may affect cognition.
- Screening visit brain MRI scan (ie, Study 201 Visit 21 (Week 71), or for Study 102, the Study 251 Screening Visit) indicative of any other significant abnormality including but not limited to multiple microhemorrhages or evidence of a single prior hemorrhage >1 cm3, multiple lacunar infarcts or evidence of a single prior infarct >1 cm3, evidence of a cerebral contusion, encephalomalacia, arachnoid cysts, or brain tumors (eg, meningioma) unless approved by the medical monitor.
- Current presence of a clinically significant major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) or any clinically significant symptom that could affect the subject's ability to participate in the study.
- Current clinically significant systemic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study.
- History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque.
- History of seizures, excluding febrile seizures in childhood.
- Weight greater than 120 kg (264 lbs).
- History or evidence of any clinically significant autoimmune disease or disorder of the immune system.
- Clinically significant infection within the last 30 days (eg, chronic persistent or acute infection).
- Treatment with immunosuppressive medications (eg, systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last three years.
- Myocardial infarction within the last two years.
- History of cancer within the last five years, with the exception of basal cell carcinoma, and nonmetastatic squamous cell carcinoma of the skin.
- Other clinically significant abnormality on screening (ie, Study 201 Visit 22 [Week 78], or Study 102 Visit 11 [Week 16]) physical, neurological, laboratory, or ECG examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject.
- Hemoglobin less than 11 g/dL at screening (ie, Study 201 Visit 22 [Week 78], or Study 102 Visit 11 [Week16]).
- Smoking more than 20 cigarettes per day.
- History of alcohol or drug dependence or abuse within the last two years.
- Current use of anticonvulsant for seizures, anti-Parkinson's, anticoagulant (excluding the use of aspirin 325 mg/day or less), or narcotic medications.
- Any prior experimental treatment with AN1792 or other experimental immunotherapeutic or vaccine for AD (other than bapineuzumab).
- Any known hypersensitivity to any of the excipients contained in the study drug formulation.
- Women of childbearing potential.
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, cerebrospinal fluid (CSF) shunts, metal fragments or foreign objects in the eyes, skin, or body that would contraindicate a brain MRI scan (unless otherwise approved by the Sponsor and/or its designees).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606476
United States, Arizona | |
Janssen AI Investigational Site | |
Peoria, Arizona, United States, 85381 | |
Janssen AI Investigational Site | |
Sun City, Arizona, United States, 85351 | |
United States, California | |
Janssen AI Investigational Site | |
Encino, California, United States, 91316 | |
Janssen AI Investigational Site | |
Irvine, California, United States, 92697 | |
Janssen AI Investigational Site | |
La Jolla, California, United States, 92037 | |
Janssen AI Investigational Site | |
Los Alamitos, California, United States, 90720 | |
Janssen AI Investigational Site | |
Sacramento, California, United States, 95817 | |
Janssen AI Investigational Site | |
San Francisco, California, United States, 94143 | |
United States, Connecticut | |
Janssen AI Investigational Site | |
New Haven, Connecticut, United States, 06510 | |
United States, District of Columbia | |
Janssen AI Investigational Site | |
Washington, District of Columbia, United States, 20057 | |
United States, Florida | |
Janssen AI Investigational Site | |
Delray Beach, Florida, United States, 33445 | |
Janssen AI Investigational Site | |
Jacksonville, Florida, United States, 32224 | |
United States, Illinois | |
Janssen AI Investigational Site | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Janssen AI Investigational Site | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Janssen AI Investigational Site | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Janssen AI Investigational Site | |
Ann Arbor, Michigan, United States, 48105 | |
United States, Minnesota | |
Janssen AI Investigational Site | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Janssen AI Investigational Site | |
St. Louis, Missouri, United States, 63108 | |
United States, New Jersey | |
Janssen AI Investigational Site | |
Eatontown, New Jersey, United States, 07724 | |
United States, New York | |
Janssen AI Investigational Site | |
New York City, New York, United States, 10032 | |
Janssen AI Investigational Site | |
Rochester, New York, United States, 14620 | |
United States, North Carolina | |
Janssen AI Investigational Site | |
Durham, North Carolina, United States, 27710 | |
United States, Oregon | |
Janssen AI Investigational Site | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Janssen AI Investigational Site | |
PIttsburgh, Pennsylvania, United States, 15213 | |
United States, Rhode Island | |
Janssen AI Investigational Site | |
Providence, Rhode Island, United States, 02906 | |
United States, Texas | |
Janssen AI Investigational Site | |
Dallas, Texas, United States, 75390 | |
Janssen AI Investigational Site | |
Houstan, Texas, United States, 77030 | |
United States, Vermont | |
Janssen AI Investigational Site | |
Bennington, Vermont, United States, 05201 | |
United States, Washington | |
Janssen AI Investigational Site | |
Seattle, Washington, United States, 98108 |
Responsible Party: | JANSSEN Alzheimer Immunotherapy Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT00606476 |
Other Study ID Numbers: |
AAB-001-251 |
First Posted: | February 4, 2008 Key Record Dates |
Last Update Posted: | November 25, 2013 |
Last Verified: | August 2012 |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |