WASHINGTON, May 15 /PRNewswire/ -- The development of therapies that could prevent Alzheimer's disease, dementia and other memory disorders calls for increased focus on early detection before symptoms emerge, significant changes in regulatory processes, emphasis on discovering new therapeutic targets and reforming current patent laws. The recommendations are published in the May 2008 issue of Alzheimer's & Dementia, the Journal of the Alzheimer's Association. "Dementia is unique because current treatments address only symptoms, not the underlying disease or prevention," said Zaven Khachaturian, Ph.D., lead author, 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 to the pending health storm is to develop ways to detect the disease early while simultaneously finding treatments that prevent it from progressing. Prevention is the priority, so we opened up the dialogue to the community concerned about this complicated disease, to look for a way to create a consensus to meet that priority." To begin to address ways to completely change the treatment paradigm in dementia to focus on prevention, more than 40 thought leaders from major academic research institutions, industry, government, and non-profit health advocacy organizations met in December 2007 to conduct a "Think Tank"-style symposium. No scientific presentations were given; instead, participants were divided into diverse working groups and asked to determine what barriers existed and how to collaboratively overcome the challenges. In December 2008, the group will convene again to finalize these recommendations into action that can be taken by the U.S. Congress to be included in any healthcare reform that is presented as of the new presidential administration in January 2009. Alzheimer's disease is the most common form of dementia and manifests as a seemingly harmless and progressive loss of cognitive functioning. Severe memory impairments are collectively one of the most serious, unheralded public health problems facing 78 million baby boomers and their loved ones. "The recommendations of the report will lead to a roadmap of viable solutions as well as 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," continued Dr. Khachaturian, the symposium organizer. "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." Participants identified three main areas for change, which are interrelated and interdependent, that were detailed in the published paper this month: Focus on early detection and prevention: It has previously been established that Alzheimer's disease begins to manifest years before a person begins to exhibit the symptoms of the disease. Additional research into understanding how mild cognitive impairment evolves, as well as the role of amyloid and tau in early detection needs to be explored separately from the work being done on symptom treatment. In addition, lack of a complete animal model -- one that more accurately represents humans with dementias -- slows the understanding of progression. This is needed to create building blocks from which targets for new medicines that get at the underlying pathology could halt progression are developed. In order to find additional biomarkers a commitment to fund more longitudinal studies such as Alzheimer's Disease Neuroimaging, Alzheimer's Disease Anti-inflammatory Prevention Trial and Gingko in Evaluation of Memory is needed. Ultimately data from these trials, singularly and collectively, may point to the need for an approach that takes into consideration multiple perspectives. Scientific and Regulatory processes: The scientific path for developing efficacious medicines is predicated on established work in the field. Structural changes that encourage 'out-of-the-box' thinking are needed. These changes, in addition to increased funding and technological support for commercial and academic trial sites would potentially increase the number of therapeutic targets, grants, trials and patients who could be treated. Preventive treatments are subtle, and harder to measure. In the case of Alzheimer's, the authors suggest that "the FDA might 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." Final approval would be dependent on replication of the results. Patent reforms: Creating feasible and powerful studies that credibly test a prevention therapy for a complex, progressive disease such as Alzheimer's will mean conducting clinical trials that study patients for longer than any current clinical trial has done to date-limiting incentives for innovators. These trials would also look at many more aspects of the disease than ever before -- which supports the overall goal of understanding more to develop early preventions treatments. More analysis is needed to find suitable solutions to properly extending the patent life, or instituting conditional approval of any resulting treatments. "Everyone knows Alzheimer's is a looming public health epidemic because of the aging of the population," said Peter Snyder, Ph.D., Lifespan Affiliated Hospitals, and 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 recommendations were developed at the inaugural Leon Thal Symposium on Prevention held December 2-4, 2007 at the Lou Ruvo Brain Institute in Las Vegas, Nevada. The symposium was organized to memorialize Dr. Thal's contribution to dementia therapy development and healthy brain aging. Dr. Thal's entire career was devoted to the study of aging and dementia. One of the world's leading investigators engaged in development of new therapies for Alzheimer's disease, his efforts contributed significantly to the world's understanding of the cause, prevention and treatment of Alzheimer's disease and related disorders. He directed more than $100 million in federally funded research grants, and was a collaborator on many others. About Alzheimer's Disease Alzheimer's disease is the most common form of dementia. It is a progressive and fatal brain disease. As many as 5 million Americans are living with Alzheimer's disease. Alzheimer's destroys brain cells, causing problems with memory, thinking and behavior severe enough to affect work, lifelong hobbies or social life. Alzheimer's gets worse over time, and it is fatal. Today it is the seventh-leading cause of death in the United States. About The Lou Ruvo Brain Institute The Lou Ruvo Brain Institute seeks to accelerate the discovery of cures for memory disorders and dementia associated with neurodegenerative diseases such as Alzheimer's, Huntington's, Parkinson's, ALS (Amyotrophic Lateral Sclerosis, commonly known as Lou Gehrig's disease) and other brain dysfunctions. The mission of the Institute is to foster the development of novel interventions to: a) maintain independent functioning, b) promote 'Vital Aging' and, c) enhance the quality of life for an ever-growing number of older people. It is located in Las Vegas Nevada. For more information, go to http://www.keepmemoryalive.org.
Leon Thal Symposium on Prevention of Dementia December 2007 Participant List* Academic Institutions Baylor College of Medicine Harvard Medical School Johns Hopkins School of Medicine Mayo Clinic McGill University, Montreal, QC, Canada MIT Mount Sinai School of Medicine New York University School of Medicine Oregon Health and Science University Sun Health Research Institute UCLA University of California, Irvine University of Connecticut University of California, San Francisco University of Michigan University of North Texas Health Science Center, Fort Worth University of Pittsburgh USC Keck School of Medicine University of Toulouse, France University of Utah University of Washington UCSD Government National Institute on Aging/National Institutes of Health Industry Elan Pharmaceuticals Eli Lilly & Company General Electric Healthcare -- USA Non-profits Organizations Alzheimer's Drug Discovery Foundation Alzheimer's Association Institute for the Study of Aging (ISOA) Keep Memory Alive Lou Ruvo Brain Institute *Additional institutions, industry and non-profits organizations support the Symposium financially but could not attend
SOURCE The Lou Ruvo Brain Institute