WEDNESDAY, April 30 (HealthDay News) -- Patients with mild
Alzheimer's disease who took 800 milligrams of the drug
tarenflurbil twice a day had less decline in functional ability
than those who took a placebo, according to a British phase II
trial.
The findings support phase III studies of the drug at this dose,
the researchers said. Tarenflurbil reduces production of
42-amino-acid peptide, which is believed to initiate brain damage
characteristic of Alzheimer's disease. Previous research had found
the drug prevented learning and memory defects in mice with
Alzheimer's disease.
In this study, 210 patients were randomly assigned to receive
either 400 milligrams of tarenflurbil twice per day (69 patients),
800 milligrams of tarenflurbil twice per day (70 patients), or a
placebo (71 patients).
Patients with mild Alzheimer's who took 800 milligrams of
tarenflurbil for 24 months had lower rates of decline than those
who were in the placebo group for the first 12 months of the study
and either tarenflurbil group for the last 12 months of the
study.
Common side effects included diarrhea, nausea and dizziness.
The researchers concluded that "800 mg tarenflurbil twice per
day was well-tolerated for up to 24 months of treatment, with
evidence of a dose-related effect on measures of daily activities
and global function in patients with mild AD ... these findings
justify phase III studies of tarenfurbil at the 800 mg twice daily
dose in patients with mild AD."
The study was published online in
The Lancet Neurology.
The findings are sufficient to support Phase III studies of the
drug, Dr. Paul Aisen of the University of California, San Diego,
wrote in an accompanying commentary.
"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.
In a few months, we will learn whether tarenflurbil will be the
first anti-amyloid intervention to be efficacious in a pivotal
trial," Aisen wrote.
More information
The U.S. National Institute on Aging has more about
Alzheimer's disease.
