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

Sponsor:	JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborator:	Pfizer
Information provided by (Responsible Party):	JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT00575055

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Bapineuzumab Drug: Placebo Control	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Primary Outcome Measures:

Cognitive and Functional [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Imaging and biochemical biomarkers of disease status [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	1121
Study Start Date:	December 2007
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bapineuzumab Dose	Drug: Bapineuzumab Comparisons of Bapineuzumab or placebo, given by infusion every 13 weeks for a total of 6 infusions.
Placebo Comparator: Placebo Dose	Drug: Placebo Control Comparisons of Bapineuzumab or placebo, given by infusion every 13 weeks for a total of 6 infusions.

Eligibility

Ages Eligible for Study:	50 Years to 88 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575055

Show 186 Study Locations

Sponsors and Collaborators

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Pfizer

More Information

No publications provided

Responsible Party:	JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT00575055 History of Changes
Other Study ID Numbers:	ELN115727-302
Study First Received:	December 10, 2007
Last Updated:	April 20, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2012