Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00667810

Purpose

This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Condition	Intervention	Phase
Alzheimer Disease	Drug: bapineuzumab Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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 In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E ε4 Non-Carriers

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Bapineuzumab

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Alzheimer's Disease Assessment Scale-Cognitive Subscale total score [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Disability Assessment for Dementia total score [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Brain Amyloid Burden [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
CSF Phospho-tau level [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
MRI Brain Boundry Shift Integral [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
Divergence of effect [ Time Frame: 39 Weeks ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
Dependence Scale [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
Proportion of Responders [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
Clinical Dementia Rating Sum of Boxes [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: bapineuzumab Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65. Other Name: AAB-001
Experimental: B	Drug: bapineuzumab Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65. Other Name: AAB-001
Placebo Comparator: C	Drug: placebo Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

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 Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD
Concurrent use of cholinesterase inhibitor or memantine allowed, if stable
Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria:

Significant neurological disease other than AD
Major psychiatric disorder
Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body]
Women of childbearing potential

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667810

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 282 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00667810 History of Changes
Obsolete Identifiers:	NCT00909623
Other Study ID Numbers:	3133K1-3000, B2521001
Study First Received:	April 24, 2008
Last Updated:	January 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

antibody
immunotherapy

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 February 09, 2012