Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)
Posted Jul 17 2010 3:33pm
By Bob DeMarcoAlzheimer's Reading Room
JANSSEN Alzheimer Immunotherapy is the sponsor of this clinical trial.
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 230 study sites in the US and Canada and up to 35 sites outside of North America will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.
Criteria 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
There are 239 clinical trial sites now open. for the list of locations.
Bob DeMarco is the editor of the Alzheimer's Reading Room and an Alzheimer's caregiver. Bob has written more than 1,610 articles with more than 8,000 links on the Internet. Bob resides in Delray Beach, FL.
JANSSEN Alzheimer Immunotherapy is the sponsor of this clinical trial.
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 230 study sites in the US and Canada and up to 35 sites outside of North America will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.
Criteria
Inclusion Criteria:
Exclusion Criteria:
There are 239 clinical trial sites now open. for the list of locations.
ClinicalTrials.gov Identifier: NCT00574132
The Alzheimer's Action Plan
300 Tips for Making Life Easier
Original content Bob DeMarco, the Alzheimer's Reading Room