Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00676143

Purpose

This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Over 150 sites will participate in over 20 countries outside of the United States. 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

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Bapineuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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 Carriers

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Neuropsychological Test Battery; Clinical Demential Rating Scale [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: bapineuzumab
B: Placebo Comparator	Drug: placebo

Eligibility

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

Criteria

Inclusion:

Diagnosis of probable AD, with MMSE score of 16-26, and brain 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:

Significant neurological disease other than AD, or a major psychiatric disorder
Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
Woman of childbearing potential

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676143

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 159 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Italy: descresg@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3133K1-3001
Study First Received:	May 2, 2008
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00676143 History of Changes
Health Authority:	South Africa: Medicines Control Council

Keywords provided by Wyeth:

antibody
immunotherapy

Study placed in the following topic categories:

Antibodies
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Immunoglobulins
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009