First US Plan to Address Alzheimer s Disease

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1 First US Plan to Address Alzheimer s Disease Ronald C. Petersen, PhD, MD Chair Advisory Council on Research, Care and Services for the National Alzheimer s Project Act 2012 MFMER

2 NAPA Advisory Committee 26 members, 14 federal, 12 non-federal Federal members represent federal agencies involved in Alzheimer s disease in the US Non-federal members Care providers Caregivers State agencies Voluntary health organizations Researchers 2012 MFMER

3 Passed by Congress 2010 December Advisory Council appointed 2011 August Advisory Committee Meeting 2012 January National Alzheimer s Project Act January 2011 September 2011 April 2012 National Plan announced 2012 May July 2012 Advisory Committee Meeting 2012 October Signed by President Advisory Committee Meeting Advisory Committee Meeting Advisory Committee Meeting 2012 MFMER

5 National Alzheimer s Project Act Goal To effectively treat Alzheimer s dissease (delay onset, slow progression) by 2025

6 US National Alzheimer s Plan Goals 1. Prevent and effectively treat AD by Enhance care quality and efficiency 3. Expand supports for people with AD and families. 4. Enhance public awareness/engagement 5. Improve data to track progress 2012 MFMER

7 Research Goal 1. Identify research priorities and milestones 2. Expand research aimed at prevention and treatment of AD 3. Accelerate efforts to identify early and presymptomatic stages of AD 4. Coordinate research with international public and private entities 5. Facilitate translation of findings into medical practice and public health programs 2012 MFMER

8 New Alzheimer s Disease Initiatives in MFMER

9 Alzheimer s Disease Projects Funded by FY 2012 NIH Additional $50 million On February 7, 2012, Secretary of Health and Human Services Kathleen Sebelius announced that $50 million would be directed immediately to boost Alzheimer s research in FY2012 in response to President Obama signing the National Alzheimer's Project Act. The following research projects will be funded: AD genome sequencing by NHGRI Genome Centers Small Business Alzheimer's Disease Research (STTR)R41/R42 - Phase I, Phase II, and Fast-Track /Small Business Innovation Research (SBIR) R43/R44 Grant - Phase I, Phase II, and Fast-Track Two AD Clinical Trials - one treatment and one prevention

10 AD Projects Funded through White House Initiative 2012 Use of new induced pluripotent stem (ips) cell methods to obtain insights into the cellular processes of Alzheimer s. Support to the Atherosclerosis Risk in Communities (ARIC) Neurocognitive study (ARIC-NCS) focused on prediction of cognitive impairment from mid-life vascular risk factors and markers. Small business grants for Alzheimer's disease research.

1000 with the E280A (Glu280Ala) Presinilin1 mutation Autosomal dominant, 100% penetrance Median

11 Amyloid PET Scans in Presymptomatic Early- Onset Alzheimer s Disease Gene Carriers Non-Carriers Age Years Age Years Columbian Kindred N = 5000 living individuals from ~ 25 families 1000 with the E280A (Glu280Ala) Presinilin1 mutation Autosomal dominant, 100% penetrance Median age of MCI = 44 years, dementia = 49 years Reiman, Fleisher and colleagues not for public distribution

12 Alzheimer s Prevention Initiative $100 million prevention/biomarker development trial: a groundbreaking public-private partnership $16 million from the NIH $15 million from the Banner Alzheimer s Institute the major share of funding from Genentech includes all of the best established AD biomarkers data & biological samples will be released to the research community as soon as possible after the trial is completed to help find faster ways to test prevention therapies intended to test an anti-amyloid treatment in the prevention of AD symptoms, to provide a better test of the amyloid hypothesis, & help establish the biomarker endpoints & accelerated approval pathway needed to rapidly test the range of promising preclinical treatments

13 Pilot Trial of Intranasal Insulin for Alzheimer s and MCI Pilot: 104 adults with MCI and mild to moderate Alzheimer s; placebo, 20 IU insulin, 40 IU insulin for 4 months, administered with nasal drug delivery device Results: o improved delayed memory in 20 IU group compared with placebo o o o preserved general cognition, activities of daily living for younger participants in both insulin groups caregivers for both insulin groups rated participant functional status higher changes in some biomarkers (Aβ42 and tau to Aβ42 ratio) associated with changes in memory and function Suzanne Craft et al, Arch Neurol 2012 January; 69(1): 29-38

White House Proposal for $80 Million Additional AD Funding in FY 2013 NIH

spending of the anticipated $80M in additional funding for AD research

identify areas of highest need/opportunity, informed by the Alzheimer s

NIA took the lead on developing FOA concepts for presentation at NACA in

14 White House Proposal for $80 Million Additional AD Funding in FY 2013 NIH is using the following process to ensure timely and most effective spending of the anticipated $80M in additional funding for AD research next year: Representatives from several NIH ICs worked together to identify areas of highest need/opportunity, informed by the Alzheimer s Summit and other input. NIA took the lead on developing FOA concepts for presentation at NACA in September Extra funding will allow NIH to support more grants through these or existing FOAs and/or investigator-initiated research.

15 Alzheimer s Disease Research Planning for FY 2013 NIH Additional $80 million May 2012 Alzheimer s Research Summit June 2012 NIH Planning process to identify FY13 initiatives August 2012 Preparation of Funding Opportunity Announcements September 2012 Review of proposed initiatives by National Advisory Council on Aging October 2012 Announcement of FOAs and schedule for applications, review, and funding in FY13, contingent on availability of funds

16 NAPA Implementation NIH Summit on Alzheimer s Disease University of Pennsylvania State of Science Alzheimer s Association Expert Committee 2012 MFMER

17 2012 MFMER

18 NIH Alzheimer s Disease Research Summit 2012 Approximately 500 attended both days Almost 500 watched nationally and internationally by webcast Representatives from 38 states and 8 countries attended HHS Secretary Kathleen Sebelius presented the National Plan and NIH Director, Dr. Francis Collins announced two AD Clinical Trials Summit webcast is archived at:

19 Alzheimer s Disease Research Summit Recommendations Organized by subgroup of 57 speakers and panelists and based on Summit discussions Provide multidisciplinary and integrated blueprint to address research goals in National Plan to Address Alzheimer s Overarching and transformative concepts identified Recommendations were made based on the 6 sessions:

20 Alzheimer s Disease Research Summit Path to Treatement and Prevention Overarching issues transcended many of the sessions Heterogeneity of the disease New research paradigms, e.g., systems biology needed Rapid and extensive data/specimen sharing Multidisciplinary translational teams Strategies to overcome IP barriers Public-private partnerships National IRB 2012 MFMER

21 NIH Research Summit 1. Interdisciplinary approach to new targets 2. Preclinical challenges 3. Whom, when, what to treat 4. Drug repurposing and combinations 5. Non-pharmacological approaches 6. New models public-private partnerships MFMER

22 International Partnerships Examples: 1) Meeting of international Alzheimer s research funders: Alzheimer s Association/National Institute on Aging July 15, 2012, Vancouver 2) Alzheimer s disease genetics - July 14, 2012, Vancouver 3) Biomarkers World-wide ADNI July 13, 2012, Vancouver International CSF biomarkers cooperation 4) Common Alzheimer s Disease Research Ontology (CADRO)

23 NAPA Implementation NIH Summit on Alzheimer s Disease University of Pennsylvania State of Science Alzheimer s Association Expert Committee 2012 MFMER

24 Advancing AD Diagnosis, Treatment, Care Ware Invitational Summit Naylor et al., MFMER

25 Penn State of the Science Decrease the time from research to clinical practice Establish a population-based international registry of elderly adults Develop a system that incorporates genetic, biologic, cognitive, and environmental markers Propose legislation requiring that information gained through biomarker studies not be used in insurance or employment decisions 2012 MFMER

26 Workgroup on NAPA s scientific agenda National initiative on Alzheimer s disease Alz. Assoc. Expert Advisory Workgroup on NAPA, MFMER

27 Alzheimers.gov New HHS website for information on resources about Alzheimer's disease and related dementias. Links to authoritative, up-to-date information from agencies and organizations with expertise in these areas.

28 Advisory Council Recommendations Increase federal funding to $2B HHS should update strategic plan Translate research into practice Compress therapeutic pipeline FDA should report to Advisory Council Metrics on impact of Plan Public-private partnerships Promote international collaborations 2012 MFMER

National Alzheimer s Plan Strategic Plan and companion Implementation Plan Implementation Tracking

HHS agencies will be able to enter their progress on action steps for which they are responsible.

ASPE will be able to create and share reports on progress across action steps for all partners as well as

29 National Alzheimer s Plan Strategic Plan and companion Implementation Plan Implementation Tracking Progress Reporting ASPE will load the National Alzheimer s Plan into the new web-based tool this summer. HHS agencies will be able to enter their progress on action steps for which they are responsible. The tool will facilitate reporting by HHS agencies. ASPE will be able to create and share reports on progress across action steps for all partners as well as identify any action steps that are outstanding. Indicators of progress can be linked to a broader set of HHS measures, to connect our effort to those of others across the Department.

30 US National Plan International collaboration is essential US Plan makes numerous references to international partnerships Research collaborations underway The US is ready to partner 2012 MFMER

31 While we all wish we could fast-forward to a time when no one has Alzheimer s disease We re not quite there

First US Plan to Address Alzheimer s Disease

First US Plan to Address Alzheimer s Disease Advisory Council on Research, Care and Services for the National Alzheimer s Project Act 2012 MFMER 3205603-1 Passed by Congress 2010 December January 2011