Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease - Full Text View

Purpose

This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients aged 50 to 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 III

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

ChemIDplus related topics:

Bapineuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

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 Non- Carriers.

Further study details as provided by Elan Pharmaceuticals:

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 ]

Estimated Enrollment:	1250
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Bapineuzumab
B: Active Comparator	Drug: Bapineuzumab
C: Active Comparator	Drug: Bapineuzumab
D: Placebo Comparator	Drug: Placebo Control

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: NCT00574132

Contacts


Contact: Study Coordinator	1-866-446-5463

Show 158 Study Locations

Sponsors and Collaborators

Elan Pharmaceuticals

More Information

Responsible Party:	Elan Pharmaceuticals ( Michael Grundman )
Study ID Numbers:	ELN115727-301
First Received:	December 10, 2007
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00574132
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Alzheimer Disease

Central Nervous System Diseases

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Nervous System Diseases

Tauopathies

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Elan Pharmaceuticals
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00574132