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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01254773

Run by

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

People needed

146

Starts

2010-12-01

Expected to finish

2013-03-01

Last updated by the study team

2014-05-09

Who can join

Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Janssen AI Investigational Site — Tucson, Arizona, United States
• Janssen AI Investigational Site — Tucson, Arizona, United States
• Janssen AI Investigational Site — La Habra, California, United States
• Janssen AI Investigational Site — Lomita, California, United States
• Janssen AI Investigational Site — Long Beach, California, United States
• Janssen AI Investigational Site — Oceanside, California, United States
• Janssen AI Investigational Site — Pasadena, California, United States
• Janssen AI Investigational Site — Santa Monica, California, United States
• Janssen AI Investigational Site — Sherman Oaks, California, United States
• Janssen AI Investigational Site — Deerfield Beach, Florida, United States
• Janssen AI Investigational Site — Delray Beach, Florida, United States
• Janssen AI Investigational Site — Fort Meyers, Florida, United States
• Janssen AI Investigational Site — Miami Springs, Florida, United States
• Janssen AI Investigational Site — South Miami, Florida, United States
• Janssen AI Investigational Site — Atlanta, Georgia, United States
• Janssen AI Investigational Site — Indianapolis, Indiana, United States
• Janssen AI Investigational Site — Kansas City, Kansas, United States
• Janssen AI Investigational Site — Lexington, Kentucky, United States
• Janssen AI Investigational Site — Plymouth, Massachusetts, United States
• Janssen AI Investigational Site — Farmington Hills, Michigan, United States
• Janssen AI Investigational Site — Creve Coeur, Missouri, United States
• Janssen AI Investigational Site — St Louis, Missouri, United States
• Janssen AI Investigational Site — Latham, New York, United States
• Janssen AI Investigational Site — Winston-Salem, North Carolina, United States
• Janssen AI Investigational Site — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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