Alzheimer's Diagnostic Guideline Validation Exploration of Next Steps: Workshop Summary (2012) / Chapter Skim
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Alzheimer's Diagnostic Guideline Validation: Exploration of Next Steps: Workshop Summary
Alzheimer's Diagnostic Guideline Validation: Exploration of Next Steps: Workshop Summary
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.1 Held in Paris, France, on July 18, 2011, the session brought together key stakeholders to discuss next steps in the validation of the new diagnostic guidelines for Alzheimer's disease (AD) , specifically, the revised guidelines recently proposed in papers by the International Working Group for New Research Criteria for the Diagnosis of Alzheimer's Disease, and three working groups under the auspices of the National Institute on Aging (NIA)
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However, scientific advances over the past decade now indicate that AD is a continuous, progressive cognitive disease, most likely beginning asymptomatically many years before dementia is apparent. This presents challenges when trying to study the patient population including characterizing patients as normal, at risk, prodromal, or having clinical dementia.
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Thies noted that there are therapeutic implications of validated predictive and diagnostic biomarkers of AD, including the potential ability to not only treat symptoms and slow cognitive decline of patients with clinical dementia, but also to slow disease progression of those in the prodromal stage, and even perhaps to prevent disease onset in the normal population (Figure 1)
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Regarding the cognitive guidelines, the International Working Group chose memory impairment as the starting point. The NIA-AA criteria took a more liberal standpoint, Scheltens said, in that they kept the term mild cognitive impairment, and also included dementia.
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Robert Mahley, senior investigator at the J David Gladstone Institutes of Cardiovascular Disease and Neurological Disease and professor of pathology and medicine and at the University of California, San Francisco, described some of the lessons learned from studies of cardiovascular disease, cholesterol, and treatment approaches that could help inform strategy development for the validation and use of biomarkers in the diagnosis of AD.
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, and change in risk factors associated with heart disease (e.g., reduction in total plasma cholesterol levels, better control of blood pressure, decreased smoking, and an increased understanding of the importance of exercise)
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Participants received cholestyramine, a bile acid sequestrant, and were followed for 7 years. The overall results indicated that total cholesterol and LDL were decreased by 13 percent and 20 percent, respectively, and there was a 19 percent decrease in cardiac events (definite CHD; non-fatal MI)
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Mahley described the Framingham Heart Study, which assessed lifetime risk for CHD associated with multiple risk factors. For example, an individual with an optimal risk burden at age 50 (normal blood pressure, low total cholesterol, absence of diabetes, nonsmoker)
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Mahley noted that a clinical trial to prove that early treatment could reduce CHD will probably never be done; the event rate in young men and women is too low, and such a primary prevention study would likely require hundreds of thousands of subjects, and 20 or more years of follow-up. Too Short Most clinical trials are about 5 years long, but cholesterol and other risk factors can be lifelong problems.
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cholesterol or high triglycerides, that warrant intervention. Metabolic syndrome is a management challenge for providers, involving the control of obesity, insulin resistance, coagulation disorders, high triglycerides, and low HDL cholesterol.
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A strong basic science foundation and integration of data from multiple types of studies is essential to understand the potentially multiple causes, interacting pathways, and risk factors. MOVING FORWARD: VALIDATION OF THE NEW DIAGNOSTIC GUIDELINES Following the presentations, Mahley was joined for a panel discussion by David Brooks, professor at Imperial College and medical advisor to GE Healthcare; Charles DeCarli, director of the Alzheimer's Disease Center at the University of California, Davis; and Monique Breteler, professor at the German Center for Neurodegenerative Diseases (DZNE)
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He suggested that standardization of Ab methodology should be first on the list of tasks. A participant pointed out that in the Framingham Heart Study, the cholesterol data was being collected before it was known that cholesterol was important for heart disease.
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Research in this area, including careful measures of trajectories of cognitive decline, could be valuable. It was also noted that conversion to dementia is the major outcome in MCI clinical trials.
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To better understand prodromal AD in the population at large and develop preventive interventions, Breteler suggested that there is a need for easier, cheaper, standardized, more accessible biomarker tests for the early stages of AD. A participant from industry discussed the development and recruitment of the first prodromal AD clinical trial based on the International Working Group guidelines, and the specific challenges of operationalizing the guidelines.
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