Alzheimer’s and Related Dementias Research: Policy

and Program Updates2018 Fall ADC Meeting

Richard Hodes, M.D.Director

National Institute on Aging

October 20, 2018

$40M for universal flu vaccine $29M increase for BRAIN$86M increase for All of US

• $3.1B for the NIA • $84M increase for NIA research; percent

increase comparable to other ICs• All divisions will benefit DBSR DGCG

DAB DN

$39 Billion for the NIH

$425M increase for AD/ADRD

AD/ADRD Targeted Increases

National Alzheimer’s Project Act (NAPA)

$50 M* redirected within NIH budget

$40 M* redirected within NIH budget

$100 M additional approp

$25 M additional approp

$350 M additional approp

$400 Madditional approp

*one-year money

Years displayed are Fiscal Years

$425 M in additional

appropriationsas of 09/28/18

2011 2012 2013 2014 2015 2016 2017 2018 2019

$414 Madditional approp

NIA AppropriationsFiscal Years 2008-2019

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019Actual Dollars $1,053 $1,081 $1,110 $1,100 $1,103 $1,046 $1,171 $1,199 $1,600 $2,049 $2,574 $3,083Constant Dollars $1,053 $1,050 $1,045 $1,003 $992 $921 $1,005 $1,002 $1,301 $1,616 $1,959 $2,260

$-

$400

$800

$1,200

$1,600

$2,000

$2,400

$2,800

$3,200

$3,600

Dolla

rs, i

n M

illio

ns

$1,046 $1,171 $1,199

$1,600

$2,049

$2,574

$3,083

$0

$500

$1,000

$1,500

$2,000

$2,500

$3,000

$3,500

2013 2014 2015 2016 2017 2018 2019

Dolla

rs (i

n m

illio

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NIA AppropriationsFiscal Years 2013-2019

NIA Base Additional AD Funds

Allocations for Competing Research Grant Awards, FY 2018

6

CSR-reviewed Research Applications

General Pay line, <$500k

General Pay line, =>$500k

AD/ADRD pay line, <$500k

AD/ADRD pay line, =>$500k

All applications except as noted below

23 20 28 25

N.I. R01s 26 23 31 28E.S.I. R01s 29 26 33 30

New investigator: An applicant who has not received a prior R01 award or its equivalent.Early-Stage Investigator: A new investigator who is within 10 years of finishing research training.First-time renewing; A former new or early-stage investigator’s first renewal application when the investigator has no other NIH grant support.ADRD: Research on Alzheimer's disease and on Alzheimer's-related Dementias

FY 2018 Pay Lines

7

NIA-reviewed Applications

General pay line

AD/ADRD pay line

Program projects (PO1) 33 38

Other NIA-reviewed research

33 38

FY 2018 Pay Lines

8

Training-related Applications

General pay line

AD/ADRD pay line

Training grants (T32, T35) 21 35

Career awards 21 28Fellowships 28 32

Over 1/4 of NIA’s Alzheimer’s and related dementias awardees from Fiscal Year 2015-2018 were either new or early stageinvestigators

Over 1/3 of NIA’s Alzheimer’s and related dementias awardees were new to the field

Recruitment to a growing AD/ADRD workforce

274

73

13

106

5010

39%68%

77%

0%

20%

40%

60%

80%

100%

0

50

100

150

200

250

300

R01 and RF1 R21 R03

Perc

enta

ge o

f NTF

s

Num

ber o

f Aw

arde

esAD/ADRD Awardees/ NTF

FY2017

Awardees NTFs Percentage

New to AD/ADRD Field (NTF): Investigator who never had any prior NIH AD/ADRD award/ application

Supplements by Institute/Center

26 25 25

21

1816 16 16

14 14 1412 11 11 10 9 8 8 7

53 3 2

0

5

10

15

20

25

30N

INDS

NHL

BI

NIM

H

NID

DK

NIE

HS NCI

NIB

IB

NIG

MS

NIA

AA

NID

A

NIN

R

NID

CD

NIM

HD

NIH

OD

NEI

NIA

ID

NCC

IH

NID

CR

NHG

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NIC

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NIA

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NLM

Coun

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Institute/Center

Opportunities for Small Business – AD/ADRD specific

• Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42/R43/R44)

• Tools for Clinical Care and Management of Alzheimer's Disease (AD) and its Comorbidities (R41/R42/R43/R44)

• Development of Socially-Assistive Robots (SARs) to Engage Persons with Alzheimer's Disease (AD) and AD-Related Dementias (ADRD), and their Caregivers (R41/R42/R43/R44)

https://www.nia.nih.gov/research/grants-funding/small-business-innovation-research-and-technology-transfer-

programs

NIA SBIR/STTR Obligations

13

Dollars in Millions

$27.5 $32.4 $34.2

$49.7

$67.2

$84.6

$0$10$20$30$40$50$60$70$80$90

2013 2014 2015 2016 2017 2018

*estimate

*

Concept Approvals:https://www.nia.nih.gov/approved-concepts

General FOAs:https://www.nia.nih.gov/research/funding

Alzheimer’s Disease and Related Dementias FOAs:http://www.nia.nih.gov/AD-FOAs

Follow our “Inside NIA” blog: https://www.nia.nih.gov/research/blog

Tracking Funding Opportunities

Neurodegenerative Disorders Biorepositories at Indiana University

Number of aliquots of…

NCRAD

DNA 143,509Plasma 85,222Serum 91,869RNA 3,092Whole Blood 5,593PBMC 20,156Fibroblast 0CSF 11,260Urine 0Tissue 350

* GEMS (2000-2008) – older collection protocol

Study Population # Plasma Aliquots

GEMS* Elderly nondemented 43,915

ARTFL/LEFFTDS/4RTNI-2

FTD 30,173

NiAD/ADDS Down Syndrome 5,198

ADNI-Depression

Cognitive decline in late life depression

5,088

SALAD Mild/Moderate AD (clinical trial)

827

LEADS Early onset AD 21

Limited high quality plasma for AD, MCI, HC

Number of aliquots of…

NCRAD

DNA 143,509Plasma 86,412Serum 91,709RNA 3,092Whole Blood 5,593PBMC 20,156Fibroblast 0CSF 11,260Urine 0Tissue 350

* GEMS (2000-2008) – older collection protocol

Study Population # Serum Aliquots

GEMS* Elderly nondemented 74,404

ARTFL/LEFFTDS/4RTNI-2

FTD 7,529

ADNI-Depression Cognitive decline in late life depression

4,958

NiAD/ADDS Down Syndrome 4,374

SALAD Mild/Moderate AD (clinical trial)

426

LEADS Early onset AD 18

Limited high quality serum for AD, MCI, HC

Neurodegenerative Disorders Biorepositories at Indiana University

Number of aliquots of…

NCRAD

DNA 143,509Plasma 86,412Serum 91,869RNA 3,092Whole Blood 5,593PBMC 20,156Fibroblast 0CSF 11,260Urine 0Tissue 350

Study Population # CSF Aliquots

ARTFL/LEFFTDS/4RTNI-2

FTD 10,449

SALAD Mild/Moderate AD (clinical trial)

777

LEADS Early onset AD 34

Limited high quality CSF for AD, MCI, HC

Neurodegenerative Disorders Biorepositories at Indiana University

Proposal: Planning Ahead

PilotN=3,000

Full Program (All ADCs)N=10,000 blood/yr; 5,000 CSF/year

2019 2020 2021 2022 2023 2024Plasma

DNA

Serum

PBMCs

RNA

CSF

Projected Increase in Centrally Banked Aliquots

0

1,000,000

2,000,000

3,000,000

4,000,000

5,000,000

6,000,000

7,000,000

Num

ber o

f Aliq

uots

Year

Cumulative Number of Aliquots With Proposed Initiative

Cumulative Number of Aliquots and Projected

2011

2012 2013

2014

2015 2016 2017

The National Alzheimer’s Project Act (NAPA) was signed into law in January – updated annually

AD Summit

ADRD Summit

AD Summit

ADRD Summit

AD Care/

Services Summit

NIH Research Implementation Milestones are Based on Broad Input

2018AD

Summit

2019ADRD

Summit

2020AD

Care/Services Summit

Newest sources of milestone

input

https://www.nia.nih.gov/alzheimers/milestones

Development of comprehensive milestones (NIH staff) – based on summit and

other input

Input at 2012-2018 meetings:Academic research community Industry Non-governmental organizationsOther Input: 2017 Request for Information

Combined External and Internal Input –FY20 AD/ADRD Bypass Budget

Trans-NIH (including NINDS) staff discussion; milestones edited to ensure comprehensive

inclusion of priorities for FY20

NIH staff “price” the milestones

Final budget estimate for

FY20

SEC. 230. Hereafter, for each fiscal year through fiscal year 2025, the Director of the National Institutes of Health shall prepare and submit directly to the President for review and transmittal to Congress, after reasonable opportunity for comment, but without change, by the Secretary of Health and Human Services and the Advisory Council on Alzheimer’s Research, Care, and Services, an annual budget estimate (including an estimate of the number and type of personnel needs for the Institutes) for the initiatives of the National Institutes of Health pursuant to the National Alzheimer’s Plan, as required under section 2(d)(2) of Public Law 111–375.

Bypass Budget Language

Trans-NIH Input for FY20 ADBB

• Thirteen Institutes and Centers provided feedback that contributed to the development of this year’s professional judgment budget:

NIA NINDS NHLBI NIAAA NICHD NIDCR NIDDK

NIEHS NIGMS NIMH NINR NCATS FIC

Using CADRO as a Framework

• The eight CADRO (Common Alzheimer’s Disease Research Ontology) categories provide the overarching framework for the FY20 AD Bypass Budget and narrative.

• CADRO provides the framework for IADRP (the International Alzheimer’s Disease Research Portfolio) and will allow tracking of implementation in the budget areas in future years.

FY20 Professional Judgment Budget –Additional Funding Needs

Molecular Pathogenesis and Pathophysiology of Alzheimer's Disease $82,000,000

Diagnosis, Assessment, and Disease Monitoring $24,000,000 Translational Research and Clinical Interventions $138,000,000 Epidemiology $51,000,000 Care and Caregiver Support $26,215,000 Research Resources $107,100,000 Alzheimer’s Disease-Related Dementias $45,687,500 Staffing Needs and Administrative Support $3,710,000 ADDITIONAL FY20 Resources Needed for New AD/ADRD Research

$477,712,500

Distribution of Additional Budget Funding Request Across Research Areas, FY20

FY20 Professional Judgment Budget –Total Funding Needs

FY19 President’s Budget Request for AD/ADRD Research (Baseline estimate)

$1,516,000,000

Difference between the FY19 President’s Budget Request and FY18 Omnibus Appropriation for AD/ADRD Research

$399,000,000

Subtotal (FY18 Omnibus – AD/ADRD Research)

1,915,000,000

ADDITIONAL FY20 Resources Needed for New AD/ADRD Research

$477,712,500

TOTAL FY20 Resources Needed for AD/ADRD Research

$2,392,712,500

FY17 AD/ADRD milestones –$323M extra

needed

FY18 AD/ADRD milestones -$414M extra

needed

FY19 AD/ADRD milestones -$597M extra

needed

$350M in FY16 supports

acceleration of FY17 milestones

$400M in FY17 supports

acceleration of FY18 milestones

Timing of ADBB Releases and AD/ADRD Appropriations

$414M in FY18 supports

acceleration of FY19 milestones

FY18 ADBBReleased

August 2016

FY17 ADBBReleased July

2015

FY19 ADBBReleased July 2017

FY20 AD/ADRD

milestones -$478M extra

needed

FY20 ADBBReleased July 2018

The AD/ADRD Bypass Budget narrativeincludes many examples of recent science advances across multiple research topics – basic to clinical, care/caregiving, etc.

AD/ADRD Progress Report –An important part of the ADBB

Care and Caregiving Actions

• National Research Summit on Dementia Care & Services - October 2017

• Planned Evidence Review: Care Interventions for Individuals with Dementia and Their Caregivers

• Improving Care for People with AD/ADRD Using Technology (iCare-AD/ADRD) Challengeo NIH’s first Eureka Prize Competition

National Research Summit on Dementia Care & Services – Next Steps

• Summit milestones have been incorporated into overarching AD/ADRD research implementation milestones Informed the FY2020 AD/ADRD Bypass Budget

• Initiatives released

• Preliminary planning for next care/services summit underway

Release of Initiatives• Disparities in Quality and Access to Dementia Care

(PAR-18-596)• Improving the Lives of Persons with Dementia (PWD):

Impacts on PWD, Families and Communities (PAR-18-596)

• Dementia Care and Caregiver Support Interventions (RFA-AG-18-030)

• NIA AD/ADRD Health Care Systems Research Collaboratory (RFA-AG-19-009)

• Pragmatic Trials for Dementia Care in Long-term Services and Support (LTSS) Settings (PAR-18-585)

• High Priority Behavioral and Social Research Networks in AD/ADRD (RFA-AG-19-016)

Save the Date

AD/ADRD Care/Services Summit (II)March 24-25, 2020Natcher Conference CenterBethesda, MD

Planned Evidence Review: Care Interventions for Individuals with

Dementia and Their Caregivers • Two parts: National Academies of Sciences, Engineering, and Medicine:

Expert panel input on questions and study designwww.nationalacademies.org/dementiacare

Agency for Healthcare Research & Quality: Evidence review

• Status: AHRQ Evidence-Based Practice Center award – Made to the

Minnesota EPC – Drs. Mary Butler and Joseph Gaugler are leading the study

NASEM Committee list – posted to https://www8.nationalacademies.org/pa/projectview.aspx?key=HMD-HSP-18-04

NASEM Committee Members

• Eric B. Larson, MD, MPH (Chair)

• Marilyn Albert, PhD

• María P. Aranda, PhD, MSW, MPA, LCS

• Marilyn Blum, BA

• Christopher M. Callahan, MD

• Eileen M. Crimmins, PhD

• Peggye Dilworth-Anderson, PhD

• XinQi Dong, MD, MPH

• Miguel Hernán, MD, DrPH

• Ronald Hickman, Jr., PhD, RN, ACNP-BC, FNAP, FAAN

• Rebecca A. Hubbard, PhD

• Jason Karlawish, MD

• Robyn I. Stone, DrPH

• Jennifer L. Wolff, PhD

iCare-AD/ADRD ChallengeImproving Care for People with AD/ADRD Using

Technology Challenge

• Submissions accepted from October 1, 2018 through June 30, 2019

• NIA challenge managers held a webinar on October 17, 2018 to introduce attendees to the Challenge and cover participation requirements

• See https://nia.nih.gov/challenge-prize for full prize details

• Seeks to spur the development of technology applications to improve dementia care coordination and/or care navigation

• Up to $400,000 in cash prizes may be awarded to teams or individuals that participate in the competition

Sessions on:• Multiple Etiology Dementias• Health Disparities• Emerging Topics• Nomenclature• Frontotemporal Degeneration• Lewy Body Dementias• Vascular Contributions to Cognitive

Impairment and Dementia

Scholarship Program: Deadline, Dec. 12

Julie Schneider, MDRush University Medical Center

Scientific Chair

Roderick A. Corriveau, PhDNINDS, Program Director

NIH Lead

MARCH 14-15, 2019NATCHER AUDITORIUM, NIH CAMPUS,

BETHESDA MD

Register online at:https://meetings.ninds.nih.gov/?ID=21149

Register now: https://meetings.ninds.nih.gov/?ID=21149