Boston University | Alzheimer's Disease Center

The ICARA (Investigational Clinical Amyloid Research in Alzheimer’s) study will evaluate the safety and effectiveness of a new drug, Bapineuzumab, in slowing the progression of Alzheimer’s disease (AD). The study has been referred to as the “Vaccine Study,” but it is not the typical “vaccine” that is given to prevent a disease. Rather, Bapineuzumab is a passive immunotherapy approach to treating AD in people who already have the disease. The ICARA study is taking place here at Boston University Medical Center, as well as at numerous national and international sites.

The ICARA Study is sponsored by Elan Pharmaceuticals, Inc.

Bapineuzumab is an antibody that may increase the clearance of beta amyloid from the brain. Beta amyloid is a protein that accumulates in brain tissue to form plaques, which is believed to play the major role in the development of AD. The drug will be given as an infusion (that is, intravenously). Study participants will be randomly assigned to receive the investigational drug, Bapineuzumab, or a placebo so there is a 60 % chance of receiving Bapineuzumab and a 40 % chance of receiving a placebo.

Who is eligible to participate?

Participants in the ICARA study must:

Have mild to moderate AD
Be between 50 and 88 years of age
Be living in the community at the time of enrollment (that is, not a rest home or nursing care facility)
Have a reliable caregiver or close relative who can accompany the participant to all clinic visits and answer questions about the participant. The caregiver must either live with the study participant or see him/her at least 5 days per week.

What happens at the visits?

Study participants are asked to:

Attend 15 study visits over the next one and a half year period
Receive six infusions of either the investigational drug or a placebo (that is, one every 13 weeks for 65 weeks)
Have blood tests and study-related physical and clinical exams

All study-related drugs and tests are paid for by the study. There are no costs to participants for being in the study.

Where is the study taking place?
Boston University Medical Center

How can I find out more?
For more information on how to participate in this or other studies, please contact Erin Whalen by phone at 617-414-1078 or email at ewhalen@bu.edu.

Key Personnel
Robert A. Stern, PhD, Principal Investigator/Site Director, Co-Director, Alzheimer’s Disease Clinical and Research Program

Anil Nair, MD - Neurologist

Jane Mwicigi, MPH - Project Manager/Coordinator

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