Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00937352
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00937352
Recruitment Status : Terminated
First Posted : July 13, 2009
Last Update Posted : December 20, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE July 7, 2009
First Posted Date  ICMJE July 13, 2009
Last Update Posted Date December 20, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 30, 2013)
896
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2009)
1350
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 51 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00937352
Other Study ID Numbers  ICMJE ELN115727-351
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Sponsor  ICMJE JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Verification Date November 2013

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