Alzheimer's, Dementia & Mental Health
Large Clinical Trial Seeks Alzheimer’s Victims to
Test Drug that May Slow the Disease
In Alzheimer's clinical trial 60% to receive free the
promising drug LY450139
Feb.
16, 2009 – Older people with “mild to moderate” Alzheimer’s disease are
being invited to apply for participation in a clinical trial being held
at sites across the U.S. and Canada to test the effectiveness of
LY450139, a drug that has shown promise in controlling the progress of
AD in animal and human studies.
“Our goal is to explore if this investigational
drug can help control the progression of Alzheimer’s,” said Franklin
Watkins, M.D., the principal investigator for the study and medical
director for the Acute Care for the Elderly Unit at the Wake Forest
University Baptist Medical Center.
“Most current therapies for Alzheimer’s treat the
symptoms associated with it and not the disease itself. It is important
for patients, and families affected by Alzheimer’s, to consider
participating in clinical studies. They are the best chance we have for
fighting this disease.”
Funded by Elan Pharmaceuticals, the study, named
Investigational Clinical Amyloid Research in Alzheimer’s (ICARA), will
last about 18 months and will include up to 1,500 patients enrolled at
research sites in North America. The site at Wake Forest University’s J.
Paul Sticht Center on Aging will follow 15 to 20 of those patients.
Alzheimer’s disease is a neurodegenerative disorder
characterized by progressive loss of memory and cognitive function. It
destroys brain cells, causing problems with memory, thinking and
behavior severe enough to affect everyday life. Alzheimer’s gets worse
over time, and it is fatal.
AD is the most common cause of dementia in the
elderly, affecting approximately 18 million people worldwide, and
Alzheimer’s-related medical complications are among the most common
causes of death in the elderly population.
Researchers want to see if the drug can slow the
progression of Alzheimer’s disease by blocking the amyloid precursor
protein, which causes the brain cells to stop working. Amyloid beta
peptide is the primary protein found in amyloid plaques in the brains of
patients with Alzheimer’s disease. It is expected that by blocking the
formation of this peptide, the rate of disease progression can be
slowed.
The study will compare LY450139 to a placebo.
Study participants 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.
Participants for the ICARA study must be between
the ages of 50 and 88, have a diagnosis of mild to moderate Alzheimer’s
disease and have a caregiver who is willing to be involved in the study.
A medical team including a nurse or study coordinator and a physician
will monitor participants throughout the study.
How can participants benefit?
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.
How to join the study
For more information about the study or to apply to
be a participant, call the toll free number1-(877)-BE-VITAL, or visit
http://www.ICARAstudy.com. Patients should also consult with their
physician.
Wake Forest University Baptist Medical Center (www.wfubmc.edu)
is an academic health system comprised of North Carolina Baptist
Hospital, Brenner Children’s Hospital, Wake Forest University
Physicians, and Wake Forest University Health Sciences, which operates
the university’s School of Medicine and Piedmont Triad Research Park.
