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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
194
IV q13w
Janssen AI Investigational Site
Peoria, Arizona, United States
Janssen AI Investigational Site
Sun City, Arizona, United States
Janssen AI Investigational Site
Encino, California, United States
Janssen AI Investigational Site
Irvine, California, United States
Janssen AI Investigational Site
La Jolla, California, United States
To assess the safety and tolerability of long-term treatment of bapineuzumab in subjects with AD.
* 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).
Time frame: 3-84 months
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: * 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
Time frame: 3-84 months
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Janssen AI Investigational Site
Los Alamitos, California, United States
Janssen AI Investigational Site
Sacramento, California, United States
Janssen AI Investigational Site
San Francisco, California, United States
Janssen AI Investigational Site
New Haven, Connecticut, United States
Janssen AI Investigational Site
Washington D.C., District of Columbia, United States
...and 19 more locations