A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
Status: | Terminated |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 51 - 90 |
Updated: | 4/21/2016 |
Start Date: | December 2009 |
End Date: | November 2012 |
A Phase 3 Extension, Multicenter, Long Term Safety And Tolerability Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww.
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 3133K1-3001(NCT00676143). Over
250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each
subject's participation will last approximately 4 years.
in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over
250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each
subject's participation will last approximately 4 years.
Inclusion Criteria:
- Subject has completed study 3133K1-3001 (Week 78) 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 Criteria:
- 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
We found this trial at
64
sites
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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