Drug May Slow Alzheimer’s Decline
Experimental Drug Flurizan Looks Promising in Trials, but More Tests Needed
April 29, 2008 -- An experimental new drug may help people with mild Alzheimer's disease by slowing the functional decline of the disease.
The results are only preliminary, but a new phase II clinical study shows that people with mild Alzheimer's disease who took the drug Flurizan experienced a 46% slower decline in performing their normal daily activities and a 36% slower decline in overall function after a year of treatment compared with those who took the placebo. However, there was no significant effect on cognition.
Flurizan is part of a new group of drugs under investigation in the treatment of Alzheimer's disease called selective amyloid-beta lowering agents (SALAs). The drugs work by targeting the buildup of amyloid-beta proteins in the brain, which is implicated in the brain damage associated with Alzheimer's.
Although experts are quick to point out that the drug is no miracle cure for Alzheimer's disease, the results were promising enough for the drug's manufacturer, Myriad Pharmaceuticals, to pursue further, phase III clinical trials.
"Do these results prove the efficacy of [Flurizan] in slowing decline in AD? No -- the data are consistent with a beneficial effect of [Flurizan] in mild AD, but are hardly conclusive," writes Paul Aisen, MD, of the University of California, in San Diego, in an editorial that accompanies the study in the Lancet.
"With the need so enormous, and the potential effect of the benefit suggested (although not proven) by these phase II results, the effort is indeed justified despite the substantial uncertainty," Aisen writes. "In a few months, we will learn whether [Flurizan] will be the first anti-amyloid intervention to be efficacious in a pivotal trial."
Alzheimer's Drug Benefits Those in Early Stages
In the study, researcher Gordon Wilcock, BCh, a professor of medicine at Oxford University in England, and colleagues evaluated the effect of Flurizan in 210 people with mild to moderate Alzheimer's disease.
The participants were divided into groups that received either 400 milligrams or 800 milligrams of Flurizan or a placebo twice a day for a year. After the year of treatment, participants were also invited to continue treatment for another 12 months. Those previously on placebo were randomly assigned to take either the 400 milligram dose or 800 milligram dose twice a day in the second 12 months.