Status:
COMPLETED
Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborating Sponsors:
Pfizer
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-89 years
Phase:
PHASE2
Brief 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 meas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01254773
Start Date
December 1 2010
End Date
March 1 2013
Last Update
May 9 2014
Active Locations (28)
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1
Janssen AI Investigational Site
Tucson, Arizona, United States, 85724
2
Janssen AI Investigational Site
Tucson, Arizona, United States, 85741
3
Janssen AI Investigational Site
La Habra, California, United States, 90631
4
Janssen AI Investigational Site
Lomita, California, United States, 90277