Trial Information

Summary: 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 E 4 Non-Carriers

This is an outpatient study for patients with mild to moderate Alzheimer's Disease. Patients will receive either the study medication at one of three dose levels (0.5mg, 1.0mg or 2.0mg) or placebo. They will be administered by IV infusion every 13 weeks for a total of 6 infusions over the course of the study. The duration of a patient's participation is approximately 83 weeks (≈ 1½ years). There are a total of 15 clinic visits. All patients must be able to go through a closed MRI as there will be 7 MRI's performed over the course of the study.

Patient Inclusion Criteria:

  • Age from 50 to <89 years
  • Has diagnosis of probable Alzheimer's Disease
  • MMSE score of 16-26, inclusive (if unavailable, MMSE's will be performed at the office)
  • Must have a caregiver who lives with or who visits with the patient at least 5 times per week for the duration of the study and is capable of accompanying the patient on all clinic visits
  • Patient could be naïve to Alzheimer's Disease medications or be on a stable dose regimen of Alzheimer's Disease medications for at least 4 months
  • Patient must have adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments

Patient Exclusion Criteria:

  • Weight can not exceed 264 lbs.
  • Significant neurological disease, other than Alzheimer's Disease, that may affect cognition
  • Current presence of a clinically significant major psychiatric disorder or symptoms (e.g., hallucinations) that could affect the patient's ability to complete the study
  • Has a history of seizures
  • Has a history of an autoimmune disease or disorder of the immune system (e.g., Crohn's Disease, Rheumatoid Arthritis)
  • Has had a stroke, TIA or atrial fibrillation
  • Has had uncontrolled hypertension within the last 6 months
  • Has had a myocardial infarction within the last 2 years
  • Has history of cancer within the last 5 years
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, CSF shunts, claustrophobia, metal fragments or foreign objects in the eyes, skin, or body that would contraindicate a brain MRI scan

Primary Objective: To demonstrate an advantage of the efficacy of multiple doses of intravenously (IV) administered bapineuzumab in patients with mild to moderate AD over placebo.

Co-Primary Endpoints:

  • The change from baseline scores for the Neuropsychological Test Battery (NTB) up to Week 78;
  • The change from baseline scores for the Disability Assessment Scale for Dementia (DAD) up to Week 78.

    • To demonstrate an advantage of the effect of multiple doses of intravenously administered bapineuzumab in patients with mild to moderate AD over placebo on additional cognitive and global measures.

    • The change from baseline scores for the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog) up to Week 78;
    • The change from baseline scores for the Clinical Dementia Rating Sum of Boxes (CDR-SOB) up to Week 78.

    Contact:

    Cheryl Nickles, Patient Recruitment Coordinator
    Chase Medical Research, LLC
    500 Chase Parkway, 3rd Floor
    Waterbury, CT 06708
    Telephone: (203) 419-4420
    Fax: (203) 465-7924
    Email:

    Profile Page: Chase Medical Research, LLC, Waterbury, CT

    If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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    Trial listings updated: June 26, 2008 at 3:12:54 PM


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