Drugs approved for Alzheimer's prevention study
A scientist points out the the buildup in the brain of amyloid protein, which is thought to be the cause of Alzheimer's disease. / CBS News
An Alzheimer's drug that was ineffective against preventing decline in cognitive and physical function in patients with late stage Alzheimer's may prove to help prevent the disease from developing in people who are genetically predisposed to getting it.
Solanezumab from Eli Lilly and gantenerumab from Roche and have been approved for use in a worldwide Alzheimer's prevention trial. A beta-secretase inhibitor being developed by Eli Lilly is also in consideration for the study.
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The study will include 160 patients who have inherited mutations that make them more susceptible to developing early-onset Alzheimer's. None of them have been diagnosed with dementia. The study will begin in early 2013.
"Trying to prevent Alzheimer's symptoms from ever occurring is a new strategy," Dr. John C. Morris, principal investigator of DIAN and the Harvey A. and Doris Friedman Distinguished Professor of Neurology at the Washington University in St. Louis School of Medicine, said in a press release. "We are most appreciative of the support this approach has received."
Roche's gantenerumab is an antibody that works by attaching itself to aggregated amyloid beta, a toxic protein that affects the brain, and helps remove them from the area. Solanezumab, on the other hand, is an antibody that latches onto soluble forms of amyloid beta before they are even created, and removes them before they are allowed to clump together and form brain plaque.
Alzheimer's is the most common form of dementia, accounting for 50 to 80 percent of all dementia cases according to the Alzheimer's Association. It is the sixth leading cause of death in the U.S. The symptoms which start out with mild memory loss and progress over time to the inability to carry on a conversation or respond to the environment.
Although the majority of people who develop the disease are older than 65, up to 5 percent of patients will have early onset forms of the disease which begins to show symptoms while the person is in their 40s or 50s. There is no current cure.
The rush to find a new treatment for Alzheimer's is especially important since no new drugs have been developed in nine years. Earlier in July, Pfizer announced that their phase III trial for their hoped for Alzheimer's drug, bapineuzumab, did not show any improvement or delay any cognitive decline or functional performance in patients with mild-to-moderate forms of the disease.
While research released in August revealed that solanezumab failed to help people remember in two studies involving people who had late-state forms of the disease, it did show a statistically significant improvement in people who had mild cases. Combined results from two studies with the drug revealed that patients who had mild Alzheimer's showed 34 percent less mental decline than those who were given a placebo.
Experts hope that solanezumab may be the much looked for treatment that patients desperately need.
"Definitely maybe," Sam Gandy, director of the Center for Cognitive Health at the Mount Sinai Medical Center in New York, told Forbes. "It's neither a definite success, nor is it a definite failure. I think it's enough encouragement to focus on the earliest stages of Alzheimer's and see if something that's really compelling can come from the next trial."
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