Short Study Name (acronym):ICARA
Long Name:A Phase III, 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 Non-Carriers (301) or Carriers (302)
Investigators (list PI first):
Franklin Watkins, MD
Jeff Williamson, MD
JANSSEN Alzheimer Immunotherapy and Wyeth Pharmaceuticals
11/2008 – 10/2011
Research questions or aims:
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group, out-patient study to assess whether an investigational drug, bapineuzumab is safe, well tolerated and effective.
Male and female participants 50 - <89 years of age with mild to moderate Alzheimer's disease.
Target # to enroll:
Target Dates of enrollment:
December 2008 – December 2010
Types of assessments and questionnaires:
Medical History, Demographics, Vitals, Weight, Physical/neurological examination, Concomitant Medications, MMSE, CDR–SB (Clinical Dementia Rating Sum of Boxes), ADAS-COG(Alzheimer's Disease Assessment Scale-cognitive subscale),RUD Lite (Resource Utilization in Dementia Lite), NPI (Neuropsychiatric Inventory), QOL-AD (Quality of Life in Alzheimer’s Disease) and ECG
Other data collected:
Blood samples for ApoE testing, safety, efficacy and biomarkers, urine, PET scans – FDG and C-11 PIB, volumetric MRI and lumbar puncture.
Study Website (if applicable):www.icarastudy.com
Coordinator Contact Info: