Saint Louis University researchers are studying whether an investigational intravenous drug given to patients with diagnosed mild to moderate Alzheimer's disease can enhance the body's own immune response in fighting the disease.

"This therapy is the first treatment of its kind and holds great potential," says George Grossberg, M.D., director of the division of geriatric psychiatry at Saint Louis University School of Medicine and principal investigator for the clinical trial.

"Immune therapy has promise for being able to modify the course of Alzheimer's disease rather than simply treat the symptoms of the disease as current FDA-approved therapies do."

Grossberg calls the treatment a "vaccination" approach because it introduces into the body an antibody to attack the plaque that forms inside the brain of those who have Alzheimer's disease.

Patients who participate in the research will receive an intravenous infusion of an antibody to the beta amyloid protein. Scientists believe beta amyloid protein triggers the death of brain cells in patients who have Alzheimer's disease.

Study participants will be randomly assigned to one of three groups: two receive different doses of the study drug, and one will receive a placebo. About 2,050 participants are sought at approximately 200 study sites in the United States and Canada.

Saint Louis University, the only study site in St. Louis, is recruiting about 40 volunteers who have mild to moderate Alzheimer's disease and are otherwise healthy.

Those eligible may be 50 to 88 years old and must have a caregiver to accompany them to all clinic visits. The caregivers also should see the volunteer at least five times a week during the study. The study is sponsored by Elan Pharmaceuticals and Wyeth Pharmaceuticals.

"It's important to note that these volunteers may stay on certain Alzheimer's disease medication," Grossberg says.

The study lasts about 85 weeks, including 65 weeks of receiving hour-long infusions of an antibody every 13 weeks at the Saint Louis University Cancer Center, 3655 Vista.

Researchers will look at physiological changes, such as whether MRIs show changes in the volume of the brain, and will examine changes to mental health through various psychiatric screening tools.

Alzheimer's disease is a progressive, neurodegenerative disease characterized by diminished function and nerve cell death in several areas of the brain. This leads to difficulty with reasoning or judgment, disorientation, loss of language skills and memory, and a decline in the ability to perform routine tasks. It frequently includes symptoms of agitation, such as pacing and irritability, as well as psychotic symptoms. Alzheimer's disease affects five million Americans and their families.

To learn more about the study, call (314) 977-4900.