Newswise — As Alzheimer's disease clinical trials continue to disappoint, combination drug therapy is emerging as the ‘New New Thing’ in Alzheimer’s disease research. Supported by the U.S. Food and Drug Administration, some 65 scientists and other stakeholders from across the country brainstormed ways to get combination trials off the ground. The occasion was the Accelerate Cure/Treatments for Alzheimer’s disease (ACT-AD) coalition’s fifth annual FDA/Alzheimer’s Disease Allies Meeting held in Rockville, Maryland.
Clinical setbacks have reinforced the idea that it may take simultaneous attacks on different targets to change the course of a disease as complex as Alzheimer’s. Many drugs being tested target amyloid plaques—a major hallmark of the disease—but neuroinflammation and neurofibrillary tangles comprising tau protein are increasingly seen as promising targets as well. On top of that, genetics research has highlighted the roles of diverse genes in the disease, including those linked to cholesterol, the immune system, and other biological processes. “The risk genes tell us it’s not one gene, it’s not one target, and it’s going to take a multiple-target approach to be successful,” said Diane Stephenson of the Critical Path Institute in Tucson, Arizona.
Researchers plant to intervene earlier in the disease, too. So far, experimental drugs have not worked well at later stages of AD. Rather than give drug combinations to people with mild to moderate dementia, scientists are planning to test them before symptoms even begin. “We are going to have to bite the bullet … and start combination trials as early as we can do it safely,” said Reisa Sperling of Brigham and Women’s Hospital in Boston, Massachusetts.
All of these drugs will still be experimental, meaning the FDA has not yet approved them. This combination approach has never been done in Alzheimer’s research, though it has been done for other disease such as cancer and HIV-AIDS. It is a large task in part because testing drugs from more than one company in one trial will require a level of scientific and legal cooperation between companies that is unprecedented in Alzheimer’s research.
Follow Alzforum's three-part series to find out more.
RSS