Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier) - Tabular View

Tracking Information
First Received Date ^ICMJE	December 10, 2007
Last Updated Date	October 11, 2011
Start Date ^ICMJE	December 2007
Estimated Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 13, 2007)	Cognitive and Functional [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00575055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 13, 2007)	Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)
Official Title ^ICMJE	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Carriers.
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase III
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: Bapineuzumab Comparisons of Bapineuzumab or placebo, given by infusion every 13 weeks for a total of 6 infusions. Drug: Placebo Control Comparisons of Bapineuzumab or placebo, given by infusion every 13 weeks for a total of 6 infusions.
Study Arms	Experimental: Bapineuzumab Dose Intervention: Drug: Bapineuzumab Placebo Comparator: Placebo Dose Intervention: Drug: Placebo Control
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	1000
Completion Date
Estimated Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years to 88 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00575055
Other Study ID Numbers ^ICMJE	ELN115727-302
Has Data Monitoring Committee
Responsible Party	( JANSSEN Alzheimer Immunotherapy Research & Development, LLC )
Study Sponsor ^ICMJE	JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators ^ICMJE	Pfizer
Investigators ^ICMJE
Information Provided By	JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP