A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00937352
First received: July 7, 2009
Last updated: November 26, 2013
Last verified: November 2013

July 7, 2009
November 26, 2013
July 2009
September 2012   (final data collection date for primary outcome measure)
Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments. [ Time Frame: Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol ] [ Designated as safety issue: Yes ]
Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments. [ Time Frame: 2.5 years or marketing application, whichever comes first ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00937352 on ClinicalTrials.gov Archive Site
To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD. [ Time Frame: The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first ] [ Designated as safety issue: No ]
To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD. [ Time Frame: 2.5 years or marketing application, whichever comes first ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer's Disease Who Participated in Study ELN115727-301 or Study ELN115727-302.

The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Bapineuzumab

0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

  • Active Comparator: Bapineuzumab 0.5 mg/kg
    0.5 mg/kg
    Intervention: Drug: Bapineuzumab
  • Active Comparator: Bapineuzumab 1.0 mg/kg
    1.0 mg/kg
    Intervention: Drug: Bapineuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
896
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probable AD
  • Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
  • Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
  • Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
  • Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)
Both
51 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Austria
 
NCT00937352
ELN115727-351
Not Provided
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
Not Provided
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
November 2013

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