Cecily O'Connor
RedwoodAge.com
Early detection of Alzheimer's - before the disease affects memory - is the best way to prevent dementia, according a report by 40 leading researchers.
Significant changes in regulatory processes, an emphasis on discovering new therapeutic targets and reform of patent laws also could help find therapies that avert dementia, according to the study reported in Alzheimer's & Dementia, the journal of the Alzheimer's Association.
Alzheimer's disease, the most common form of dementia, is a fatal disease characterized by the progressive loss of cognitive functioning. It's becoming one of the biggest public health problems facing millions of aging baby boomers. More than 5 million people live with Alzheimer's today, and that figure is expected to triple over the next 40 years.
"Dementia is unique because current treatments address only symptoms, not the underlying disease or prevention," said Dr. Zaven Khachaturian, editor of Alzheimer's & Dementia. "We know that changes in the brain eventually evolve into abnormal neurodegenerative disorders that begin years before symptoms arise. The only viable solution ... is to develop ways to detect the disease early while simultaneously finding treatments that prevent it from progressing."
Alzheimer's clouds brain cells, causing problems with memory, thinking and behavior that affect work, hobbies and social life. Alzheimer's gets much worse over time, eventually its victims. It is the seventh-leading cause of death in the US.
To increase the nation's focus on prevention, more than 40 experts from major academic research institutions, industry, government, and non-profit health advocacy organizations met in December to participate in a "think-tank" symposium organized by Khachaturian.
"Everyone knows Alzheimer's is a looming public health epidemic because of the aging of the population," said Dr. Peter Snyder, a symposium participant. "Our goal is to make changes in the approach to this disease with a renewed focus on slowing its progression, or preventing it, to protect quality of life for our patients."
The group will convene again at the end of 2008 to finalize its recommendations, and plans to bring them to Congress for inclusion in healthcare reform that will be presented to the new presidential administration in January 2009.
Ahead of those meetings, some political figures have been bending Congress' ear, including retired justice Sandra Day O'Connor, whose husband suffers Alzheimer's. O'Connor urged legislators to speed research to fight the coming epidemic.
Outside of political circles, there has been more attention paid recently to brain fitness programs to slow the onset of memory loss disorders. But symposium participants are urging more radical, fundamental changes. They identified three main areas for change:
Focus on early detection and prevention: Alzheimer's begins to manifest long before a person shows symptoms. That's why additional research into understanding how mild cognitive impairment evolves, as well as the role of abnormal proteins in the brain, needs to be explored separately from the work being done on symptom treatment, according to the report. In addition, lack of a complete "animal model" that more accurately represents humans with dementias has slowed the understanding of memory loss progression. As a result, the authors urge a "commitment to fund more longitudinal studies" to better understand the underlying pathology.
Scientific and regulatory processes: Structural changes that encourage "out-of-the-box" thinking are needed to develop successful treatments, the report emphasized. These changes, in addition to increased funding, could increase the number of therapeutic targets, grants, trials and patients who could be treated. Because preventive treatments for Alzheimer's are "subtle and harder to measure," the authors suggest that the Federal Drug Administration "consider conditionally approving drugs for preventive treatments under tightly regulated conditions even when those drugs achieve only minimal or moderate results in terms of efficacy."
Patent reforms: Creating studies that credibly test a prevention therapy for a complex disease such as Alzheimer's means conducting trials that study patients longer than any current clinical trial has done to date. These trials would also look at many more aspects of the disease than ever before. But longer studies would undermine profitability for the companies funding the research. So more analysis is needed to find solutions to extending the patent life, or instituting conditional approval of any resulting treatments.
These recommendations are part of an " approach that fosters collaborations to leverage multiple perspectives on how to address the complex problem versus various patch-work measures, which to date have not been successful," Khachaturian said. "The next step is to refine the current recommendations for an action plan by soliciting wider input and translating these recommendations into specific public policy or legislative initiatives."
