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A look inside a "Big Science" Initiative for
Alzheimer Disease
Newswise — The Alzheimer
Research Forum (“Alzforum”), an
authoritative Web resource widely read by
researchers, is releasing a six-part series
on the Alzheimer’s Disease Neuroimaging
Initiative (ADNI), the largest study ever to
fill a central knowledge gap in the
Alzheimer disease field.
Announced in October 2004 and
set to run until 2010, the ADNI is a
public-private consortium that has engaged
58 research centers in the U.S. and Canada
in a massive effort to follow 819 research
volunteers for three years.
Beginning this week, the
Alzforum reports on the first waves of
much-awaited data generated by the study,
and also takes readers behind the scenes for
a look at the challenges that had to be
overcome in getting so many groups to work
together effectively.
ADNI set out to identify
biological markers that can reliably
foretell whether a still-healthy person is
on the way to developing full-blown
Alzheimer disease.
Such markers are essential in
order to test – and some day prescribe –
treatments to slow down or prevent the
disease.
Objective and quantitative
ways to measure how quickly a person
progresses with AD will enable future drug
trials to be smaller and faster, and thereby
attract investors who now shy away from AD
drug development because its trials have a
reputation of being costly and prone to
failure.
The need for such markers is
so universally acknowledged across academia
and industry and at the FDA that both
academic and industry leaders have set aside
their usual competition around this goal.
Funded to the tune of $64
million -- $40 million from the National
Institute on Aging, and $24 million to date
from a consortium of pharmaceutical
companies and private foundations -- ADNI is
a massive and complex 5-year study.
The 58 participating research
centers all conduct the same long list of
tests in 819 people in exactly the same way,
and upload all the information into a
database that is freely accessible to
qualified scientists around the world for
analysis.
All academics studying
neurodegeneration and every company
developing AD drugs around the world can use
the integrated database of ADNI results for
their purposes.
At this level, ADNI data are
not subject to embargoes, journal
subscription, or even peer review. Those
factors apply later, as investigators from
within and outside ADNI publish their own
analyses of ADNI data in scientific
journals.
For their part, the research
volunteers made a big commitment. They
undergo a range of tests over the course of
several days at each 6-month visit –
extensive clinical, neuropsychological
tests, different kinds of brain imaging,
blood test and even a spinal tap to look for
telltale signs of impending AD in the
cerebrospinal fluid.
The key to the success or
failure of this huge, shared effort is
standardization. Sound dull? It’s not.
Only if all research centers
do things in exactly the same ways will they
produce a large dataset that can speak with
authority. This is critical because at
present, at least a dozen highly regarded
labs have promising results on potential AD
imaging and biochemical markers.
However, each study, even if
well performed within its scope and
institution, has used small groups of
different patients and done their work
differently enough to make it impossible to
compare the results and decide which
candidate markers are indeed the best.
One of ADNI’s express goals
is to vet candidate markers and imaging
methods side by side so the best may ‘win’
and go on to modernize clinical drug trials.
In essence, ADNI aims to speak with a loud
voice over the cacophony of present-day
research studies, and in this way to
facilitate a consensus on biomarkers among
scientists and federal regulators.
ADNI represents the latest
example in a movement to standardize and to
unify that has been gradually building in
U.S. Alzheimer science in the past decade
(Other such examples are the NACC and the
ADCS). It also has inspired similar studies
in Japan, Europe, China, and Australia.
In its six-part report, the
Alzforum, widely regarded as an
authoritative news source by researchers,
describes how ADNI evolved from its origins
in 2004 and is beginning to produce results.
The Alzforum series delves
into how well the standardization and
coordination among all the participating
groups has gone, and what the
actual scientific results are.
To read the series, go to:
http://www.alzforum.org/new/detail.asp?id=1939
About the Alzheimer Research
Forum
The Alzheimer Research Forum (www.alzforum.org),
founded in 1996, is the web's most dynamic
scientific community dedicated to
understanding Alzheimer disease and related
disorders.
Access to the web site is
free to all. The Forum’s editorial
priorities are as diverse as the needs of
the research community.
The web site reports on the
latest scientific findings, from basic
research to clinical trials; creates and
maintains public databases of essential
research data and reagents; and produces
discussion forums to promote debate, speed
the dissemination of new ideas, and break
down barriers across the numerous
disciplines that can contribute to the
global effort to cure Alzheimer's disease.
The ARF team of professional
science writers and editors, information
technology experts, web developers and
producers all work closely with its
distinguished and diverse Advisory Board to
ensure a high quality of information and
services.
The Alzheimer Research Forum
is an independent nonprofit organization
supported by grants and individual
donations. The web site does not endorse any
specific product or scientific approach.
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