(Corrects seventh paragraph to say Amyvid was approved in
Europe this week, instead of awaiting approval in Europe)
* Researchers aim for 30 pct slowing in cognitive decline
* Volunteers to be selected using Lilly brain-amyloid test
* Lilly shares rise 0.5 percent
By Ransdell Pierson
Jan 18 Researchers have selected Eli Lilly and
Co's experimental treatment, solanezumab, for a
federally sponsored study of whether Alzheimer's disease can be
slowed or prevented in older patients who have not yet developed
significant memory problems.
The closely watched "A4" prevention study will select 1,000
participants aged 70 to 85 who have varying levels in their
brains of amyloid protein - believed to be a main cause of the
"This is the first time investigators will test an
amyloid-clearing drug in older individuals thought to be in the
pre-symptomatic stage of Alzheimer's disease," Brigham and
Women's Hospital said on Friday.
The affiliate of Harvard Medical School is helping
coordinate the three-year study, which could cost up to $100
Solanezumab, a monoclonal antibody given by infusion, failed
in two earlier Lilly-sponsored trials to slow the progression of
the disease in patients who already had mild and moderate
But when data from the two large Phase III trials was
combined and analyzed last summer, cognitive declines were
slowed by 34 percent among patients who started out with only
mild symptoms. It was the first time any drug ever arrested the
progression of Alzheimer's.
In the new prevention trial, patients will be selected by
using a radioactive Lilly imaging agent called Amyvid
(florbetapir) that can detect amyloid plaques in the brain. The
agent is approved in the United States and was also approved in
Europe this week.
Dr. Reisa Sperling, a Harvard neurology professor who will
lead the A4 trial, said she and her colleagues are hoping
solanezumab will reduce memory decline by 30 percent. That would
be similar to the benefit seen among already mildly symptomatic
patients in Lilly's earlier pair of large studies.
"But in asymptomatic people, a 30 percent slowing might
prevent symptoms from ever developing at all," Sperling said.
"In others, they might develop symptoms, but not get to the
stage where they need help with daily activities," she said in
Sperling said final data from the trial will not be seen
until 2018. Meanwhile, other Alzheimer's drugs will be tested
beginning next year as part of her project, including a
promising class of drugs called beta secretase inhibitors.
Solanezumab and an anti-amyloid drug being developed by
Roche Holding AG were selected in October for another
high-profile prevention trial, but it involves younger patients
with a genetic high risk of developing Alzheimer's disease.
The study will begin early this year at Washington
University School of Medicine in St. Louis. It is being
supported by DIAN, a U.S.-funded collaboration of leading
Alzheimer's disease centers worldwide.
Lilly shares closed 0.8 percent higher on the New York Stock
(Reporting By Ransdell Pierson; Editing by Gerald E. McCormick,
Steve Orlofsky and Andre Grenon)