ST. LOUIS -- In a new multicenter study, SLU researchers are studying a drug that is injected under the skin to learn if it is safe and effective in helping those who suffer from mild to moderate Alzheimer's disease. Investigators want to know if bapineuzumab, which works as an antibody to amyloid beta, the key component of the plaques in the brain which are implicated in Alzheimer's disease, will reduce or halt the progression of the illness.
|George Grossberg, M.D.|
Alzheimer's disease is a neurodegenerative disorder that leads to progressive memory loss and cognitive function. The illness is the most common cause of dementia in the elderly, affecting approximately 30 million people worldwide. Its prevalence increases with advancing age: among those who are 60 or older, approximately 5 percent will have Alzheimer's; among those who are 85 or older, it may strike as many as one in three.
The illness is difficult for individuals and costly to society, says George Grossberg, M.D., director of geriatric psychiatry and principal investigator for the study at Saint Louis University School of Medicine.
"As Alzheimer's disease advances, patients increasingly rely on family or professional caregivers for help with daily living and often require placement in a nursing home," Grossberg said. "Because the disease can span more than a decade, Alzheimer's creates a vast social and financial burden on society and extracts an immeasurable emotional toll on family members."
In their search for a treatment for Alzheimer's disease, researchers have discovered that Alzheimer's disease is linked to the presence of amyloid beta plaques in the brain. For this study, investigators will test bapineuzumab, an antibody against amyloid beta, to see if it will both reduce or eliminate the formation of plaque and reduce or stabilize progression of Alzheimer's disease.
Investigators will enroll men and women 50 to 89 years old who have mild to moderate Alzheimer's disease in this randomized, double-blind, placebo-controlled study. Bapineuzumab will be given subcutaneously, under the skin. Doctors hope that, should this approach prove safe and effective, it will be more accessible and convenient than alternatives because patients will not have to receive treatment in an infusion center.
The drug will be given once a month at doses of 2mg, 7mg, or 20mg. In addition, one group will be given a placebo. Approximately 90 participants will receive bapineuzumab and 30 will receive a placebo at 25 study sites, with 120 people enrolled overall. The trial will last around 28 months and participants must be accompanied by a caregiver who will attend all clinic visits. Participants are allowed to be on current Alzheimer's therapies.
All study related medications and tests will be provided at no cost to participants. The study is sponsored by Janssen Alzheimer Immunotherapy.
To learn more about the study, call Saint Louis University at (314) 977-4900.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious diseases.