REPORT: MB #2886
BACKGROUND: The possibility of developing Alzheimer's disease (AD) is a scary thought for many. Alzheimer's sneaks up on patients and their families, destroying the memories of more than half of all people in the United States over age 85. There are currently two classes of medications approved by the Food and Drug Administration to treat AD, including acetyl cholinesterase inhibitors and glutamate inhibitors, which may be used together or alone. The drugs are designed to treat the symptoms of AD and other factors that may be contributing to memory loss, but they cannot reverse the condition.
A NEW ALZHEIMER'S DRUG? A phase 3 trial of the drug bapineuzumab, a humanized, monoclonal antibody, is currently underway and is providing hope that AD can be not just slowed, but actually reversed. The therapeutic antibody works by binding to and clearing beta-amyloid, an abnormal protein in the brain associated with AD. Specifically, it targets amyloid-beta-42, the harmful form of amyloid. The peptide or amino acid causes a buildup of amyloid plaque that initiates in the hippocampus and disperses to the frontal and temporal lobes. The plaque builds up between nerve cells. Plaque accumulation in the brain has been an indication of Alzheimer's disease for about a century, but only recently have treatments been developed to try to eliminate the abnormal protein. In previous studies, anti-amyloid-beta antibodies have been demonstrated to stop the accumulation of beta-amyloid peptides in the brains of mice with AD (Shenk et al., 1999; Bard et al., 2000; DeMattos et al., 2001). Cognitive decline has also been reversed in mice who receive this type of therapy (Morgan et al., 2000).
The 18-month phase 2 trial of about 240 people at 29 centers around the United States was designed to determine safety and dosage level of bapinezumab. Elan and Wyeth, the drug companies involved in the research, say the results did not show a statistically significant effect for the drug in slowing Alzheimer's in the 128 patients who received it; however, since the trial lasted just a year and a half with only a small amount of people treated and some receiving a small amount of the drug, it does not mean bapineuzumab is ineffective against the disease. After the study was completed, analyses showed the drug was especially valuable in patients with the e4 variant of the apolipoprotein-E gene, the second-strongest risk factor for AD.
HOPE FOR MANY: For the five million people in the United States living with Alzheimer's, and the doctors treating them, this new medication is providing hope for a cure. "I think the most exciting part is that this drug is looking more to modify the disease rather than slow down the progression," Malgorzata Franczak, M.D., a neurologist at the Medical College of Wisconsin and the Milwaukee study coordinator, told Ivanhoe. More than 1,200 volunteers will be tested with the new drug. Study participants must have mild to moderate Alzheimer's disease and must be between 50 and 88 years of age. The drug could be very significant for those in the early or pre-stages of the disease, when patients do not have a lot of pathology in the brain, because it could slow down the progression of the disease or actually stop it. "I'm hoping that in my career and lifetime we will find the cure for this disease at some point," Dr. Franczak said. "I think we are much closer right now than we've ever been in the past."
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