Alzheimer's Disease
Conditions
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.
Interventions
given by infusion every 13 weeks for a total of 6 infusions.
DRUGPlacebo Control
given by infusion every 13 weeks for a total of 6 infusions.
given by infusion every 13 weeks for a total of 6 infusions.
Sponsors
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 88 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive and Functional | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive and Global | 18 months |
| Imaging and biochemical biomarkers of disease status | 18 months |
Countries
United States
Outcome results
None listed