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 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
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
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
"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.
The results show that people with mild Alzheimer's disease who took the
higher dose experienced slower rates of decline in activities of daily living
and overall function compared with those who took the placebo.
However, the overall rate of Alzheimer's-related mental decline did not
differ significantly between the treatment groups.
In people with moderate Alzheimer's disease, neither treatment dose of
Flurizan had any significant effect on the progression of the disease.
Overall, researchers say the study shows the 800 milligram dose was well
tolerated for up to two years of treatment and merits further study in a
larger, phase III clinical trial. The most common side effects were diarrhea, nausea, and dizziness, which were reported at similar levels among
all treatment groups, the researchers write.