Government Relations Update
National Institute on Aging sponsors Alzheimer’s Disease Research Summit
By Pat Kobor
By Pat Kobor
Attendees at the Alzheimer’s Disease Research Summit on May 14 and 15, 2012, filled the National Institute of Health’s largest conference venue, the Ruth Kirschstein Auditorium. The summit was organized as part of the National Alzheimer’s Plan, a comprehensive federal effort to coordinate national resources on Alzheimer’s disease research, care and services. The summit featured 57 speakers: psychologists Jennifer Manly of Columbia University, David Lowenstein of the University of Miami, Kirk Erickson of the University of Pittsburgh and Suzanne Craft of the University of Washington were among them.
The summit generated a set of broad recommendations for increasing and enhancing research on Alzheimer’s disease (AD). The recommendations were presented in six categories:
Interdisciplinary Approach to Discovering and Validating the Next Generation of Therapeutic Targets
Challenges in Preclinical Therapy Development
Whom to Treat, When to Treat and What Outcomes to Measure
Drug Repurposing and Combination Therapy
New Models of Public-Private Partnerships
One recommendation from the first category was to develop a better systems-level understanding of how the many discoveries that have already been made (using genetic, pathological, biochemical, radiological and neuropsychological approaches) and the contributory factors that have already been identified (e.g., A-beta, tau, apoE4, alpha-syneculein, TDP-43, aging, proteostatis failure, mediators of inflammation, comorbidities) are related mechanistically.
Regarding challenges in preclinical therapy development, the summit recommendations included establishing a network of AD preclinical therapy centers that are integrated with existing and proposed translational infrastructure and resources (such as the AD Neuroimaging Initiative and AD Centers) and establishing an open-access resource for reviewing and publishing negative and discrepant data.
In the category on treatment and outcomes, summit recommendations included the expansion of large-scale registries and natural history cohorts of healthy individuals from early midlife to late life, as well as individuals with subjective and/or objective cognitive impairment. Data from these individuals could be used to inform clinical trial design, including oversampling from underrepresented minorities and groups with lower education. Another recommendation was to develop, validate and standardize sensitive neuropsychological and other clinical and behavioral measures to detect and track the earliest clinical manifestations of AD and to predict long-term clinical and functional outcomes.
Regarding nonpharmacological interventions (which include behavioral, lifestyle and environmental approaches), the summit adopted a recommendation to initiate rigorously designed clinical trials in asymptomatic, cognitively impaired older adults in order to establish the effectiveness of physical exercise, cognitive training and the combination of these interventions for AD treatment and prevention. Another recommendation was to pursue the science of behavioral change for successful implementation of effective nonpharmacological interventions.
Recommendations to establish new models of public-private partnerships included a call to enable partnerships for data sharing and for creating, validating and sharing tools for translational research (e.g., instruments and biomarkers, animal models, high-throughput screening assays and iPS cells). There were repeated calls during the summit for the establishment of a National Institutional Review Board for Alzheimer’s studies accessible to both public and private research funding organizations.
How much of this work the National Institute on Aging (NIA) is able to accomplish will depend in large measure on the resources it receives. In January, President Obama announced the diversion of $50 million in current NIH Fiscal Year 2012 funds for AD research, and the Administration’s budget for Fiscal Year 2013 includes $80 million additional for Alzheimer’s from the Prevention and Health Promotion Fund that was created by the Affordable Care Act. The $80 million remains a proposal for now, subject to the Fiscal Year 2013 appropriations process.
Kathleen Sibelius, secretary of the Department of Health and Human Services, attended the Summit to announce that she had approved the final draft of the National Plan to Address Alzheimer’s Disease. The plan has been in development since the National Alzheimer’s Project Act was signed into law in early 2011. The Act’s purpose was to create and maintain an integrated national plan to overcome Alzheimer’s disease; coordinate Alzheimer’s disease research and services across all federal agencies; accelerate the development of treatments that would prevent, halt, or reverse the course of Alzheimer’s disease; improve early diagnosis and coordination of care and treatment of Alzheimer’s disease; improve outcomes for ethnic and racial minority populations that are at higher risk for Alzheimer’s disease; and coordinate with international bodies to fight Alzheimer’s globally.
The American Psychological Association along with other organizations presented comments on two earlier drafts of the Plan.
Pat Kobor is Senior Science Policy Analyst in the APA Science Government Relations Office.