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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:
About the Alzheimer Research
Forum 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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