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Bapineuzumab (ICARA)
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
| Status: | Active, Not Recruiting |
| Eligible Population(s): | Alzheimer's Disease |
| GCO Number: | 08-0241 / 08-0242 IRB approved through 02/06/2010 |
| Principal Investigator: | Hillel Grossman, MD |
| Study Coordinator: | George Marzloff |
This study is also known as Investigational Clinical Amyloid Research in Alzheimer's (ICARA).
The current medications for Alzheimer’s disease are mostly aimed at maximizing the brain activity. The ICARA study is evaluating the safety and effectiveness of an investigational drug aimed at slowing down the disease progression.
You may be eligible if you:
- Are between 50 and 88 years of age
- Have a diagnosis of probable Alzheimer's disease
- Have a caregiver who is willing to be involved in the study with you
Clinical research is necessary to learn whether the investigational drugs work and are safe. The information gained from this study could help future patients who need this type of medical care.
Participants will receive, at no charge, the investigational drug, physical exams, and laboratory services and tests. Throughout the study, participants will be monitored by a medical team including a nurse or study coordinator and a physician.
As a study participant you will be asked to:
- Attend 15 study visits during an 83-week period
- Receive six infusions of the investigational drug every 13 weeks for 65 weeks
- Have blood tests and study-related physical and clinical exams
Participants will be randomized to investigational product or placebo (a treatment with no active ingredient). There is a 60 percent chance of receiving the investigational drug and a 40 percent chance of receiving a placebo.
For more information, please contact George Marzloff at Mount Sinai's Alzheimer's Disease Research Center, 212-241-1514. Hillel Grossman, MD, Principal Investigator.