Study Evaluating the Safety and Efficacy 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

NCT00676143

B2521002 (Other Identifier)

2007-005995-14 (EudraCT Number)

3133K1-3001

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: 1,100 patients

Sex: All

Ages: 50 to 88 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,100 participants in 2 patient groups, including a placebo group

Bapineuzumab 0.5 mg/kg

Experimental group

Treatment:

Drug: bapineuzumab

Placebo

Placebo Comparator group

Treatment:

Drug: placebo