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Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease

This study is currently recruiting participants.
Information provided by Elan Pharmaceuticals

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Descriptive Information Fields
Brief Title  Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease
Official Title  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Carriers.
Brief Summary

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients aged 50 to 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Primary Outcome Measure  Cognitive and Functional [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Condition  Alzheimer's Disease
Intervention  Drug: Bapineuzumab
Drug: Placebo Control
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  800
Start Date  December 2007
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age from 50 to less than 89
  • Mini-Mental Status Exam score of 16-26 inclusive
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
  • Smoking greater than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
  • Prior treatment experimental immunotherapeutics or vaccines for AD
  • Women of childbearing potential
  • Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
Gender Both
Ages 50 Years to 88 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Study Coordinator     1-866-446-5463        
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00575055
Organization ID ELN115727-302
Secondary IDs ††
Study Sponsor  Elan Pharmaceuticals
Collaborators ††
Investigators 
Information Provided By Elan Pharmaceuticals
Verification Date August 2008
First Received Date  December 10, 2007
Last Updated Date August 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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