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.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00998764
First received: October 16, 2009
Last updated: September 11, 2013
Last verified: September 2013

October 16, 2009
September 11, 2013
December 2009
October 2012   (final data collection date for primary outcome measure)
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 ]
  • Incidence and severity of treatment emergent adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Clinically important changes in vital signs [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Weight [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Electrocardiogram (ECG) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Laboratory determinations [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Brain magnetic resonance imaging (MRI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Physical and neurological examinations [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Infusion site assessments [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00998764 on ClinicalTrials.gov Archive Site
Alzheimer's Disease Assessment Scale-Cognitive Subscale; Disability Assessment for Dementia, Neuropsychiatric Inventory [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Disability Assessment for Dementia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Neuropsychiatric Inventory [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer Disease
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
Experimental: Bapineuzumab 0.5 mg/kg
Intervention: Drug: Bapineuzumab 0.5 mg/kg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
493
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
51 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   United States,   Argentina,   Australia,   Belgium,   Chile,   Finland,   France,   United Kingdom,   Japan,   Netherlands,   New Zealand,   Poland,   Portugal,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland
 
NCT00998764
3133K1-3003, B2521004
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP