Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Alzheimer Disease

Treatments: Drug: bapineuzumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00667810

2007-005994-79 (EudraCT Number)

B2521001 (Other Identifier)

3133K1-3000

Details and patient eligibility

About

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.

Enrollment: 901 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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901 participants in 3 patient groups, including a placebo group

Bapineuzumab 0.5 mg/kg

Experimental group

Treatment:

Drug: bapineuzumab

Drug: bapineuzumab

Bapineuzumab 1.0 mg/kg

Experimental group

Treatment:

Drug: bapineuzumab

Drug: bapineuzumab

Placebo

Placebo Comparator group

Treatment:

Drug: placebo