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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: August 24, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: Bapineuzumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1350
Study Start Date: July 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bapineuzumab 0.5 mg/kg
0.5 mg/kg
 Drug: Bapineuzumab
Comparison of 0.5 mg/kg to 1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
Active Comparator: Bapineuzumab 1.0 mg/kg
1.0 mg/kg
 Drug: Bapineuzumab
Comparison of 0.5 mg/kg to 1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937352

  Show 191 Study Locations
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
  More Information

No publications provided

Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00937352     History of Changes
Other Study ID Numbers: ELN115727-351
Study First Received: July 7, 2009
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Austria: Austrian Agency for Health and Food Safety (AGES)
Germany: Paul-Ehrlich-Institut (PEI)

Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:
Mild to moderate Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013