Alzheimer's Disease: The Draft National Plan, Part II

Key to advancing this goal is the Obama Administration's investment of $50 million in new Alzheimer's disease research funding in fiscal year 2012 and $80 million in new Alzheimer's disease research funding in fiscal year 2013. These investments will open new opportunities in Alzheimer's disease research and jumpstart efforts to reach the 2025 goal.

Strategy 1.A: Identify research priorities and milestones

Research agencies undertake research planning processes on an ongoing basis, but a special effort is needed to identify the priorities and milestones to achieve Goal 1. The actions below will identify the priorities, establish milestones, and ensure that appropriate stakeholders are involved in the planning process aimed at minimizing Alzheimer's disease as a health burden by 2025.

• Action 1.A.1: Convene an Alzheimer's disease research summit with national and international scientists to identify priorities, milestones, and a timelineIn May 2012, the National Institute on Aging (NIA) of the National Institutes of Health will convene a research summit, Alzheimer's Research Summit 2012: Path to Treatment and Prevention, to provide expert input into identification of research priorities, to explore public and private research collaborations, and to establish strategies and milestones for an ambitious plan to slow progression, delay onset, and prevent Alzheimer's disease. The summit will include national and international experts in Alzheimer's disease and dementia research, public and private stakeholders, and members of the Advisory Council on Alzheimer's Research, Care, and Services. Summit proceedings will be open to the public.
• Action 1.A.2: Solicit public and private input on Alzheimer's disease research prioritiesHHS will continue to seek input and feedback from the public on its Alzheimer's disease research. Specifically, NIA will issue a Request for Information (RFI) to invite public and private input on funded research addressing Alzheimer's disease and related dementias.
• Action 1.A.3: Regularly update the National Plan and refine Goal 1 strategies and action items based on feedback and inputHHS and its federal partners will use the input received through the Alzheimer's disease summit and the RFI to inform implementation of the National Plan. An updated Goal 1 will reflect the priorities, milestones, and timeline elements identified through these processes to accelerate research in this area. These will be incorporated into the next iteration of the National Plan and will be updated on an annual basis with the input of the Advisory Council.

• Action 1.A.4: Convene a scientific workshop on other dementias in 2013HHS will expand the work undertaken in Actions 1.A.1 and 1.A.2 to address non-Alzheimer's dementias. NIH will hold a scientific workshop in 2013 to solicit input on special research priorities and timelines for addressing related dementias.
• Action 1.A.5: Update research priorities and milestonesTo ensure that the research priorities and milestones reflect the broad input of the scientific community and the public, one Advisory Council meeting per year will be focused on this area. A relevant subcommittee focused on research or Goal 1 will collect input and recommend priorities and milestones for consideration by the Advisory Council as official recommendations. As appropriate, researchers in the field will also be invited to present at these meetings.

Strategy 1.B: Expand research aimed at preventing and treating Alzheimer's disease

HHS and its federal partners will expand clinical trials on pharmacologic and non-pharmacologic ways to prevent Alzheimer's disease and manage and treat its symptoms. The federal government will address the challenge of enrolling in clinical trials enough people who are representative of the country's population, including ethnic and racial populations that are at higher risk for AD, through new partnerships and outreach. These actions will build on ongoing research focused on the identification of genetic, molecular and cellular targets for interventions and build on recent advances in the field.

• Action 1.B.1: Expand research to identify the molecular and cellular mechanisms underlying Alzheimer's disease, and translate this information into potential targets for interventionIncomplete understanding of the disease mechanisms that lead to AD is a major barrier to the discovery of effective therapies. An integrated interdisciplinary basic science research agenda will continue to advance our understanding of the molecular, cellular, and tissue level mechanisms and networks involved in the AD disease process to enable the identification and selection of therapeutic targets.
• Action 1.B.2 Expand genetic epidemiologic research to identify risk and protective factors for Alzheimer's diseaseNIH will undertake a new initiative to conduct whole genome sequencing to identify areas of genetic variation that correspond to increased risk (risk factors) or decreased risk (protective factors) of AD. This research is expected to yield novel targets for drug development, provide improved diagnostics for screening and disease monitoring, and ultimately help define strategies for disease prevention.
• Action 1.B.3: Increase enrollment in clinical trials and other clinical research through community, national, and international outreachIncreased enrollment in clinical trials is crucial for the development of better treatments and ultimately a cure for AD. Participating in clinical trials and other research also enables volunteers to have access to the latest experimental approaches available and provides them care by clinical research staff. HHS will convene representatives from across the federal government, state and local governments, academic medical research institutions, and the private sector to create an action plan for increasing enrollment in clinical trials, including through the building of registries. The partners will identify approaches and coordination points for these efforts to implement the action plan.
• Action 1.B.4: Monitor and identify strategies to increase enrollment of racial and ethnic minorities in Alzheimer's disease studiesNIH will monitor enrollment of racial and ethnic minorities in NIH Alzheimer's disease studies and work with other research funders to do the same. NIH will use this information to identify next steps for engaging and enhancing research participation by racial and ethnic minorities.

• Action 1.B.5: Conduct clinical trials on the most promising pharmacologic interventionsHHS and the Department of Veterans Affairs (VA) will continue to develop and conduct clinical trials on the most promising pharmaceuticals for the prevention and treatment of Alzheimer's disease. NIA is a primary funder of large investigator-initiated clinical trials including the Alzheimer's Disease Cooperative Study (ADCS). Clinical trials will continue to advance the development of interventions and evaluate their effectiveness. HHS will increase the pace of work under its cooperative agreement with VA and other federal agencies to advance the progress of clinical trials. HHS will also pursue research partnerships with the private sector.
• Action 1.B.6: Continue clinical trials on the most promising lifestyle interventionsHHS and its federal partners will continue to conduct clinical trials to test the effectiveness of lifestyle interventions and risk factor reduction in the prevention of AD, conduct peer review of new grant applications, perform annual reviews of ongoing studies, and work to identify emerging opportunities for the development of new interventions.

Strategy 1.C: Accelerate efforts to identify early and presymptomatic stages of Alzheimer's disease

Significant advances in the use of imaging and biomarkers in brain, blood, and spinal fluids have made it possible to detect the onset of Alzheimer's disease, track its progression, and monitor the effects of treatment in people with the disease. Without these advances, these neurodegenerative processes could only be evaluated in non-living tissues. Accelerated research will improve and expand the application of biomarkers in research and practice. These advances have shown that the brain changes that lead to Alzheimer's disease begin up to 10 years before symptoms.¹³ Identifying imaging and other biomarkers in presymptomatic people will facilitate earlier diagnoses in clinical settings, as well as aid in the development of more efficient interventions to slow or delay progression.

• Action 1.C.1: Identify imaging and biomarkers to monitor disease progressionHHS will expand its work to identify imaging and biomarkers through the public-private Alzheimer's Disease Neuroimaging Initiative (ADNI). This partnership will help identify and monitor disease progression, even in the early stages before individuals show symptoms of the disease.
• Action 1.C.2: Maximize collaboration among federal agencies and with the private sectorHHS will maximize the effectiveness of research findings in neuroimaging and biomarkers through partnerships, meetings, and conferences with the private sector, FDA, and other federal agencies. These collaborations will focus on how to translate findings into treatments and clinical practice, as well as help identify promising new areas of exploration.

Strategy 1.D: Coordinate research with international public and private entities

In order to facilitate communication and collaboration, build synergy, and leverage resources, it is imperative that research across nations and across funders be coordinated. The actions below will formalize the coordination process beyond HHS and the federal government and make research available to the public for input.

• Action 1.D.1: Inventory Alzheimer's disease research investmentsBeginning in 2012, HHS will build on an ongoing effort by NIA to complete, disseminate, maintain, and annually update an inventory of national and international Alzheimer's disease research investments. This inventory will inform and facilitate coordination among researchers, their organizations, and funders. NIA will use the Alzheimer's disease research ontology, recently developed in collaboration with the Alzheimer's Association, as a framework for collecting, organizing, and comparing the portfolios of national and international public and private Alzheimer's disease research funders. HHS will compile the portfolio information and make it available to the public through a searchable online database.
• Action 1.D.2: Expand international outreach to enhance collaborationHHS will expand outreach to international partners on Alzheimer's disease research. NIA will continue to collaborate with the Canadian Institutes of Health Research and the Research Councils of the United Kingdom and reach out to the additional eight countries that are developing Alzheimer's disease or dementia research plans. HHS will invite these colleagues to meet and discuss ongoing research priorities, and to provide research project information and categorization for the inventory.

Strategy 1.E: Facilitate translation of findings into medical practice and public health programs

Currently, promising research and interventions are published in the research literature and presented at scientific meetings. Additional steps are needed to highlight promising findings and to facilitate dissemination and implementation of effective interventions to the general public, medical practitioners, the pharmaceutical industry, and public health systems quickly and accurately.

• Action 1.E.1: Identify ways to compress the time between target identification and release of pharmacological treatmentsHHS will convene a group to examine ways to speed up the processes for bringing pharmacological treatments to market, including: identifying and validating therapeutic targets; developing new interventions; testing efficacy and safety; and regulatory approval. The group will look at the current average time and will identify places where the timeline could be shortened. The group will include representatives from the Food and Drug Administration, the Office of the Assistant Secretary for Planning and Evaluation (ASPE), and NIH who will consult with academic researchers and representatives from private industry.
• Action 1.E.2: Leverage public and private collaborations to facilitate dissemination, translation, and implementation of research findingsHHS will expand its work to disseminate research findings. NIH will partner with other federal agencies to disseminate research findings to networks of providers and researchers. FDA will work with the pharmaceutical and medical device industries to clarify the types and characteristics of data needed for approval and clinical implementation. Other HHS and federal partners will form collaborations to promote the translation of evidence-based findings to community and practice settings. For example, the Administration on Aging (AoA) and NIH will continue their collaboration on translational research focused on helping older adults maintain their health and independence in the community. HHS will explore partnerships with stakeholder groups to facilitate further dissemination.

• Action 1.E.3: Educate the public about the latest research findingsHHS, VA, and other federal agencies will expand their outreach efforts to more effectively inform the public about research findings, including results from clinical trials and studies regarding the non-pharmacological management of physical, cognitive, and behavioral symptoms. The NIA's Alzheimer's Disease Education and Referral (ADEAR) Center will continue its focus in this area, and work with AoA and the Centers for Disease Control and Prevention (CDC) to expand outreach to include the findings of studies that center on community and public health interventions.