News
Oct. 13, 2004 - OSU MEDICAL CENTER PART OF NATIONAL ALZHEIMER’S
INITIATIVE
COLUMBUS, Ohio – The Ohio State University Medical Center
will participate in a new $60 million, five-year national project
exploring whether a series of neuroimaging tests, other biological
markers and neuropsychological assessments can be combined to
more effectively measure the progression of mild cognitive impairment
and early Alzheimer’s disease.
The study, a public-private partnership announced today by the
National Institute on Aging (NIA), is designed to help researchers
and clinicians develop new treatments for Alzheimer’s disease
and monitor their effectiveness, as well as reduce the time and
cost of clinical trials. The project is the most comprehensive
effort to date to find neuroimaging and other biomarkers – biochemical
indicators that can be used to measure disease progress or effects
of treatment – for the cognitive changes associated with
mild cognitive impairment and Alzheimer’s disease.
Identifying biomarkers and standardizing neuroimaging methods
could provide a better way to compare results from different
studies, a major goal of the initiative. Previous research has
suggested that neuroimaging may serve as a more sensitive and
consistent measure of disease progression than the neuropsychological
and cognitive assessments typically used in research and clinical
practice, and that some biological tests also may contain markers
for dementia.
Federal health agencies are joining forces with a number of
private and corporate partners in funding the initiative, with
an estimated third of the funding coming from pharmaceutical
companies.
Dr. Douglas Scharre, director of the division
of cognitive neurology at OSU Medical Center, will lead Ohio State’s participation
in the initiative. OSU is one of approximately 50 sites across
the United States and Canada that will screen patients for the
initiative.
“This is an exciting project, and it may be a sign of
the future where academia-derived research is partly supported
by industry partnerships through the NIA,” Scharre said. “In
this study, we’ll be looking at markers for Alzheimer’s
disease rather than at the effects of a specific drug.”
Scharre also said the study’s design represents a break
from tradition by making all clinical, imaging and biological
data available to the public as information is collected.
“Researchers will be able to use data quickly. Access
is going to be almost up-to-the-minute,” he said. “Large
tissue data banks will be made available so other investigators
could come in and design additional research. These data will
provide impetus for research that could stretch out for many
years.”
Scharre has led or been involved in a number of published studies
of specific medications’ effects on Alzheimer’s disease
patients, and developed a test several years ago to assess Alzheimer’s
patients’ ability to continue driving. He also is medical
director of the neurobehavior and memory disorders clinics at
OSU Medical Center.
Alzheimer’s disease is an irreversible disorder of the
brain and the most common cause of dementia in people over age
65, affecting an estimated 4.5 million Americans. People with
mild cognitive impairment have ongoing memory problems, but are
able to maintain daily activities.
This national study, called the Alzheimer’s Disease Neuroimaging
Initiative, will begin screening participants in April 2005.
About 800 adults, ages 55 to 90, will be recruited to participate – approximately
200 cognitively normal older individuals to be followed for three
years, 400 people with mild cognitive impairment to be followed
for three years, and 200 people with early Alzheimer’s
disease to be followed for two years.
The study will compare neuroimaging, biological and clinical
information from these participants, seeking correlations among
the data that will track the progression of memory loss from
its earliest stages. Neuroimaging research has suggested that
PET (positron emission tomography) or MRI (magnetic resonance
imaging) can provide clearer measures of disease progression
than assessments currently used to evaluate patients.
As mild cognitive impairment and Alzheimer’s progress,
for example, areas of the brain involved with memory, such as
the hippocampus, shrink. Using the high-resolution images produced
by MRI, researchers will evaluate the best ways of measuring
this volume loss in the hippocampus and other brain structures.
PET scans assess brain function by measuring the rate of metabolism
of glucose, the brain’s fuel. PET scans of people with
Alzheimer’s show that glucose in certain parts of the brain
is metabolized at lower levels than in healthy people, and previous
studies have shown that low glucose metabolism can be seen in
some people even before noticeable symptoms of memory loss occur.
The initiative will seek to identify additional biological factors
from blood, cerebrospinal fluid and urine samples.
Scharre said details of each site’s role in the study
have not been finalized, but OSU Medical Center has PET and MRI
capabilities, including one MRI machine that doubles the magnetic
strength of the most commonly used MRI scanners. The medical
center also houses a cerebrospinal fluid tissue bank. Other cognitive
neurology specialists and radiology researchers will partner
with Scharre on the work at OSU.
The NIA, part of the National Institutes of Health, is joined
in this initiative by the National Institute of Biomedical Imaging
and Bioengineering and the Food and Drug Administration. More
than a third of the initiative will be funded by contributions
from Pfizer Inc., Wyeth Research, Eli Lily and Co., Merck & Co.
Inc., GlaxoSmithKline, AstraZeneca AB, Novartis Pharmaceuticals
Corp., Eisai Global Clinical Development, Elan Corp. and the
Institute for the Study of Aging. The Alzheimer’s Association
also is participating.
Those interested in participating in the study can contact the
NIA’s Alzheimer’s Disease Education and Referral
(ADEAR) Center at 800-438-4380 for more information.
Related links:
Click here to visit the ADEAR Web site
Emily Caldwell
Medical Center Communications
614.293.3737
caldwell-6@medctr.osu.edu