Alzheimer's Disease, Biological Markers, and the Collaboration of Mankind
Posted Aug 13 2010 7:26am
By Bob DeMarco Alzheimer's Reading Room
“The problem in the field was that you had many different scientists in many different universities doing their own research with their own patients and with their own methods,” said Dr. Michael W. Weiner of the San Francisco Department of Veterans Affairs, who directs ADNI. “Different people using different methods on different subjects in different places were getting different results, which is not surprising. What was needed was to get everyone together and to get a common data set.”
Most people in the Alzheimer's community believe that not enough is being done to find an effective treatment or cure for Alzheimer's disease. Until a cure is found this will be the common belief.
There are always two sides to a coin and sometimes it is more instructive to look at what is being done.
This brings me to the Alzheimer's Disease Neuroimaging Initiative (ADNI).
The Alzheimer's Disease Neuroimaging Initiative was funded with $60 million .
The funding came from several disparate sources
$40 million from the National Institute on Aging and National Institute of Bioimaging and Bioengineering, parts of the National Institutes of Health (NIH)(this is us, federal funding),
and, $20 million from the Pharmaceutical Industry* and several foundations.
The monies once raised were donated to the Foundation for National Institute of Health.
The funds were then awarded to the Northern California Institute for Research and Education for use, and the study is coordinated by the Alzheimer's Disease Cooperative Study (ADCS) at the University of California, San Diego.
The private - public partnerships was designed to test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessment can be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer’s disease (AD).
In other words, to learn more about Alzheimer's disease, how it unfolds in the brain, and to discover biological markers that indicate probable Alzheimer's disease in an individual.
This project was unprecedented because of its collaborative nature -- scientists in different locations working on the same problem and then contributing the fruits of their research to a central database of information that could be used by any other group of scientists.
Collaboration means all the science, and all the data from the project, are shared and made freely available to all scientists.
This is very different than the typical research model where discoveries are owned and patented. Basically locking away the research from other scientists.
With the Alzheimer's Disease Neuroimaging Initiative no one owns the data and anyone can use the data. There are no patents on the "intellectual property".
Of course, this does not preclude drug companies from using the information to develop new drugs or tests and profit as a result of their own research and development efforts.
In fact the purpose of the project was to make the cycle faster. To create intellectual property that could be freely shared and that could be used to lead the way to a treatment and cure for Alzheimer's disease.
What do you think is a better model? Several small groups of scientists with a few million in funding working on their own and keeping anything they find or discover a secret.
Or, a large group of scientists with $60 million in funding sharing all of their information with any interested scientist or group?
As far as I can tell there are more than 100 research studies that are currently being conducted to test drugs or treatments that might help slow or stop Alzheimer's disease.
Much of this research is being furthered by information coming out of the Alzheimer’s Disease Neuroimaging Initiative.
More than 50 universities and research groups are participating in ADNI research.
The Alzheimer’s Disease Neuroimaging Initiative (ADNI) began in October 2004 as a landmark study with a public-private partnership that gathered and analyzed thousands of brain scans, genetic profiles and biomarkers in blood and cerebrospinal fluid (CSF). Although the original goal was to define biomarkers for use in clinical trials to determine the best way to measure treatment effects of Alzheimer’s disease (AD), the goal has been expanded to using biomarkers to identify AD at a pre-dementia stage. ADNI involves scientists at 59 research centers, 54 in the U.S. and five in Canada. There are over 800 participants comprised of 200 with AD, 400 with mild cognitive impairment (MCI) and 200 with normal cognition.
Some of the leading-edge technologies under study are brain-imaging techniques, such as positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in the brain); PET using a radioactive compound (PiB) that measures brain beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain’s structure and function change as AD starts and progresses.
Biomarkers in cerebrospinal fluid are revealing other changes that could identify which patients with MCI will develop Alzheimer’s. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid. (Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer’s disease.)
The next step is to scan and analyze the brains of people with early mild cognitive impairment (eMCI). With a generous grant from American Recovery and Reinvestment Funds ADNI researchers will be able to study people with eMCI. This new grant expands the scope of ongoing research under ADNI by allowing for the enrollment of participants at an earlier stage of MCI, when symptoms are milder.
Furthermore, the funding for this new grant will allow ADNI investigators to extend the length of the original study to better assess changes in individuals over time. All of the participants will have neuroimaging scans and blood and cerebrospinal fluid analyses to look for changes in the brain.
The overall impact of the added funding will be increased knowledge of the sequence and timing of events leading to MCI and AD, development of better clinical and imaging/fluid biomarker methods for early detection and for monitoring the progression of these conditions. This will facilitate clinical trials of treatments to slow disease progression and will ultimately contribute to the prevention of AD.
In 2009, ADNI made a significant step forward in developing a test to help diagnose the beginning stages of AD sooner and more accurately by measuring levels of two biomarkers—tau and beta-amyloid proteins—in cerebrospinal fluid.
*Abbott (ABT), AstraZeneca (AZN), Bayer Schering Pharma (SHRGY), Bristol-Myers Squibb (BMY), Eisai Global Clinical Development (ESALY), Elan Corporation (ELN), Genentech (DNA), GE Healthcare, GlaxoSmithKline (GLX), Innogenetics (INNX), Johnson and Johnson (JNJ), Eli Lilly (LLY), Medpace, Inc., Merck (MRK), Novartis (NVS), Pfizer (PFE), F. Hoffman-La Roche, Schering-Plough, Synarc, Inc., and Wyeth.
Bob DeMarco is the editor of the Alzheimer's Reading Room and an Alzheimer's caregiver. Bob has written more than 1,690 articles with more than 70,000 links on the Internet. Bob resides in Delray Beach, FL.