A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
This study has been terminated.
(The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.)
Information provided by (Responsible Party):
First received: October 16, 2009
Last updated: September 11, 2013
Last verified: September 2013
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.
Drug: Bapineuzumab 0.5 mg/kg
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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 e4 Carriers And Participated In Study 3133K1-3001.
Primary Outcome Measures:
- Incidence and severity of treatment emergent adverse events, clinically important changes in vital signs, weight, ECG, laboratory determinations, brain magnetic resonance imaging (MRI), physical and neurological examinations and infusion site assessments [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Alzheimer's Disease Assessment Scale-Cognitive Subscale; Disability Assessment for Dementia, Neuropsychiatric Inventory [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
Experimental: Bapineuzumab 0.5 mg/kg
Drug: Bapineuzumab 0.5 mg/kg
I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Other Name: AAB-001
|Ages Eligible for Study:
||51 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998764
||Pfizer CT.gov Call Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 16, 2009
||September 11, 2013
||United States: Food and Drug Administration
Keywords provided by Pfizer:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders