Landmark Alzheimer's Report Urges Radical Changes to Paradigm of Therapy Development for Alzheimer's Disease and Dementias to Focus on Prevention

Recommendations from 40 of the World's Top Dementia Experts Suggest New

Therapeutic Targets, Adaptive Trial Design and Patent Reforms Could Lead to

Therapies That Prevent Dementia



May 15, 2008, 01:00 ET from The Lou Ruvo Brain Institute

    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
    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