Press Release - Jan 18, 2013
Researchers Announce Treatment Choice for Alzheimer’s disease (A4) Prevention Clinical Trial
Researchers from the Center for Alzheimer Research and
Treatment (CART) at Brigham and Women's Hospital (BWH) announced today the
selection of solanezumab as the first therapeutic drug to be evaluated in the
highly anticipated Anti-amyloid Treatment in Asymptomatic Alzheimer's disease (A4)
prevention clinical trial. 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. The trial will enroll older individuals with
evidence of amyloid in their brains - a hallmark of Alzheimer's disease - but
who do not show clinical symptoms of the disease. The trial is funded by
the National Institutes of Health (NIH), part of the US Department of Health
and Human Services, and by private sector contributions.
"We carefully considered a number of promising anti-amyloid
treatments for the A4 trial over the past six months." said Reisa Sperling, MD,
principal investigator for the A4 trial, and the director of CART at BWH. "Our
committee ultimately reached the decision that solanezumab was the best choice
for this first trial in asymptomatic people at high risk for cognitive
Earlier this week the National Institutes on Aging, the
lead NIH institute on Alzheimer's research, announced funding for the
three-year A4 trial, which will enroll 1,000 patients, ages 70-85, who have
evidence of the abnormal amyloid protein building up in the brain detected on
PET scans. The A4 trial will be facilitated by the Alzheimer's Disease
Cooperative Study (ADCS), a consortium of academic Alzheimer's disease clinical
trial centers, led by Paul Aisen, MD at University of California, San Diego.
The ADCS was established by the NIH in 1991 to advance research on the
treatment of Alzheimer's disease.
"Solanezumab has a good safety profile, and we were
encouraged by the evidence of a modest clinical benefit in the mild Alzheimer's
disease dementia patients in the Phase 3 trials.
Our confidence level in solanezumab grew after the results
were confirmed through an independent, academic analysis by the ADCS released
in early October," said Sperling, who is also a professor of Neurology at
Harvard Medical School and the director of the Harvard Aging Brain Study at the
Massachusetts General Hospital and BWH. "We hope that starting treatment much
earlier in the disease, before symptoms are present, as well as treating for a
longer period of time, will slow cognitive decline and ultimately prevent
Alzheimer's disease dementia."
The A4 researchers also announced that they will use florbetapir
as the PET amyloid tracer to select participants for the trial.
Florbetapir is an FDA approved PET imaging agent for detecting the presence of
absence of amyloid in the brains of patients with cognitive impairment who are
being evaluated for Alzheimer's disease and other causes of cognitive
decline. It is also being used in several other large academic studies.
Keith Johnson, MD from Massachusetts General Hospital will lead the PET amyloid
imaging aspects of the A4 trial. Drs. Sperling and Johnson made the
announcement about the selection of solanezumab and florbetapir at the 7th
Annual Human Amyloid Imaging meeting on January 18 in Miami.
"This large scale study would not be possible without
public-private partnerships," Sperling said, "Alzheimer's disease is a looming
public health crisis, and this is a great example of how academia, government
and industry can work together towards finding a successful treatment."
Solanezumab is a monoclonal
antibody in Phase III clinical trials. Discovered and developed by Eli Lilly
and Company, it binds to soluble monomeric forms of amyloid beta after it is
produced, allowing it to be cleared before it clumps together to form plaques.
AmyvidTM (florbetapir F 18 injection) is developed and manufactured by Avid Radiopharmaceuticals,
Inc., which was acquired as a wholly owned subsidiary of Lilly in 2010.