Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Bapineuzumab 0.5 mg/kg; Drug: Bapineuzumab 1.0 m/kg; Drug: Placebo Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT00575055

ELN115727-302

Details and patient eligibility

About

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 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.

Enrollment: 1,121 patients

Sex: All

Ages: 50 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,121 participants in 3 patient groups, including a placebo group

Bapineuzumab 0.5 mg/kg

Experimental group

Description:

infusion every 13 weeks for a total of 6 infusions

Treatment:

Drug: Bapineuzumab 0.5 mg/kg

Placebo Dose

Placebo Comparator group

Description:

infusion every 13 weeks for a total of 6 infusions.

Treatment:

Drug: Placebo Control

Bapineuzumab 1.0 m/kg

Experimental group

Description:

infusion every 13 weeks for a total of 6 infusions.

Treatment:

Drug: Bapineuzumab 1.0 m/kg