Status:
TERMINATED
A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
Lead Sponsor:
Pfizer
Conditions:
Alzheimer Disease
Eligibility:
All Genders
51+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over 250 sites will...
Eligibility Criteria
Inclusion
- Subject has completed study 3133K1-3000 and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease
- Mini-Mental Status Examination (MMSE) \>=10 at screening
- Caregiver able to attend all clinic visits with subject
Exclusion
- Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
- Any significant brain MRI abnormality.
- Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00996918
Start Date
December 1 2009
End Date
November 1 2012
Last Update
January 1 2014
Active Locations (82)
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1
Pfizer Investigational Site
Hornsby, New South Wales, Australia, 2077
2
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
3
Pfizer Investigational Site
Woodville South, South Australia, Australia, 5011
4
Pfizer Investigational Site
Heidelberg Heights, Victoria, Australia, 3081