Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1) safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Collaborator: Pfizer

Criteria

Inclusion Criteria:

• Diagnosis of probable AD

• Age from 50 to less than 89

• Mini-Mental Status Exam score of 18-26 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

• Amyloid burden on screening PET scan consistent with diagnosis of AD

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