ICARA

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

Funding Agency:
JANSSEN Alzheimer Immunotherapy and Wyeth Pharmaceuticals

Funding Dates:
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. 

Target population:
Male and female participants 50 - <89 years of age with mild to moderate Alzheimer's disease. 

Target # to enroll:
10 

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: 
Patricia Wittmer
Email:  
pwittmer@wakehealth.edu
Phone:  336-713-8243

 

 

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