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Advances in Diagnosis & Support for Individuals with Alzheimer’s and Dementia

Heather M. Snyder, Ph.D.Vice President, Medical & Scientific Relations

Disclosures

• I have no disclosures.

• I am a full-time employee of the Alzheimer’s Association.

ALZ.ORG

1-800-272-3900 WE ADVOCATE

SEED

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Dynamic, Durable, Multi-dimensional, Multi-faceted Research Program

ALZHEIMER’S ASSOCIATIONRESEARCH STRATEGY

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Educational Objectives

• Increase understanding of advancements in Alzheimer’s and dementia biomarker research

• Identify diagnostic tools available to primary care providers

• Recognize the importance of and steps to provide comprehensive care planning for individuals with dementia

$305 BILLION IN COSTSto care for people with Alzheimer’s

$195 billion to Medicare and Medicaid

1 in every 5 Medicare dollars

“the most expensive malady in the U.S.”

--Associated Press

The Top Line

Sources:New England Journal of Medicine: “Monetary Costs of Dementia in the United States,” New England Journal of Medicine, 2013Quotation: Associated Press, April 4, 2013$290/$195: 2019 Alzheimer’s Disease Facts and Figures, pg.43$1/$5: Calculation from Lewin Group econometric model

Alzheimer’s and other dementia add to the difficulty and cost of managing care for adults, creating more expensive hospitalizations and increased emergency department visits.

Most people with dementia are 65 or older, which puts them at increased

risk of COVID-19

IMPACT OF COVID-19 ON COGNITIONIN PEOPLE LIVING WITH DEMENTIA

Many people with dementia are likely to

have underlying health problems. This can

increase their risk for COVID-19

complications

COVID-19 may negatively impact the

brain and affect thinking, learning

and cognitive skills in people with dementia

How Alzheimer’s Increases Costs1. Alzheimer’s complicates the management of other conditions

• More than 95% of those with Alzheimer’s have one or more other chronic conditions

• Mismanagement or additional management increases health care costs

81%

64%60% 58%

47%39% 39%

Osteo-arthritis

Diabetes COPD Stroke KidneyDisease

CancerHeartDisease

Average Increase in Medicare Costs When Senior with Specified Condition Also Has Alzheimer’s

95%: Chronic Conditions Warehouse, Centers for Medicare and Medicaid ServicesGraph: Calculated from 2020 Alzheimer’s Disease Facts and Figures, pg. 49, except Osteoarthritis figure: Unpublished data from the National 5% Sample Medicare Fee-for-Service Beneficiaries for 2014

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Primary care providers may be especially well-positioned to perform this evaluation, ensure timely follow-up.

Early detection has medical, social, emotional, planning and financial benefits.

A cornerstone of early detection is assessment of cognitive impairment.

94% of primary care physicians say it's important to assess seniors for cognitive impairment.

82% of seniors believe it is important to have their thinking and memory checked.

Source: Alzheimer’s Association Facts & Figures Special Report 2019

And seniors are waiting for physicians to recommend testing.

Physicians are waiting for seniors to report symptoms —

But only half of seniors are being assessed for cognitive decline.

Source: Alzheimer’s Association Facts & Figures Special Report 2019

Healthy Brain

Advanced Alzheimer’s

Neuritic Plaques Neurofibrillary Tangles

Extracellular deposits of beta-amyloid

Intracellular deposits of hyperphosphorylated tau

NeurodegenerationCortical Atrophy

HALLMARK PATHOLOGY OF ALZHEIMER’S DISEASE

Cognitively Unimpaired Alzheimer’s Dementia

Biomarkers History & Cognition

MODERNIZING THE DIAGNOSIS OF ALZHEIMER’S

20years or more before symptoms appear,

the brain changes of Alzheimer’s may begin.Jack et al 2011 Alzheimer’s & Dementia; Sperling et al 2011 Alzheimer’s & Dementia; Albert et al. 2011 Alzheimer’s & Dementia; McKhan et al 2011 Alzheimer’s & Dementia

BIOMARKERS ARE CHANGING THE GAME

Biofluid Analysis Emerging MarkersBrain Imaging

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Advances in Brain Imaging

• Amyloid PET and the IDEAS study

• Tau PET and other emerging research on imaging

• Many for research use

National study on utility of amyloid PET scans

~18,500 Medicare beneficiaries

With mild cognitive impairment (MCI) or dementia of uncertain cause

Aim 1: Impact of scan on care management plan

Aim 2: Impact of scan on major medical outcomes

Two-thirds of participants had a change in their diagnosis and/or care management as a result of their PET scan results

THE IDEAS STUDY

NEW IDEAS: A STUDY TO IMPROVE PRECISION IN AMYLOID PET COVERAGE AND PATIENT CARE

STUDY APPROVED BY CMS APRIL 2020

• Recruit diverse cohort of 7,000 Medicare beneficiaries

• At least 2,000 African-Americans/Blacks and 2,000 Latinx/Hispanics

• Early-onset and late-onset dementia

• Typical and atypical clinical presentations of AD

• Biorepository (DNA and plasma) and image archive

• Build on and replicate findings from the first IDEAS study in a more diverse population, emphasizing recruitment of ethnoracially diverse populations

• Need for a comprehensive, multi-disciplinary approach to ensure access to high quality clinical care for all, including those from underrepresented populations

Biofluid Biomarkers

• Cerebrospinal fluid

• Blood and plasma

Cerebrospinal Fluid (CSF)• CSF AD biomarkers are effective surrogates for neuropathology;

lumbar puncture (spinal tap) to obtain CSF • A consortia of academic experts and diagnostic companies are

collaborating to improve diagnostic accuracy, reference standards and reference methods – specifically focused on AB and Tau but other measures too

• Appropriate Use Criteria for CSF use • Identify & monitor the biochemical effect of a drug candidate in

clinical trials• CSF biomarker testing has IVD status in some European countries:

• In routine clinical practice • For patient selection in international treatment trials

Hendrix et al 2018 Alzheimer’s & Dementia

Standardization of Alzheimer’s Blood Biomarkers (SABB)• Blood as a potential biomarker• A consortia of academic experts and diagnostic

companies• On-going research to improve pre-analytical protocol• Potentially detects early biological changes• Discussing universal method with global feasibility• Standardizing Aβ, tau, neurofilament light (NfL)• For research purposes but may lead to ability to

identify & monitor the biochemical effect of a drug candidate in clinical trials

On-going Initiative

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TAU: ANOTHER BLOOD BIOMARKER EMERGES

While still in research stages, blood tests are easier to administer and more accessible than current methods of evaluating Alzheimer’s

Research suggests that a form of tau called p-Tau217 is very specific to Alzheimer’s and, when measured in the blood, is highly accurate in distinguishing Alzheimer’s from other neurodegenerative disorders.

https://alz.org/aaic/pressroom.aspBarthelemy et al 2020 JEMHaanson et al 2020 JAMA

Other Emerging Biomarkers

• Changes in the eye

• Genetic measures

• Saliva measures

• Skin biopsies

• And more …

Adapted from PhRMA 2018

3 - 6 years 6 - 7 years 0.5 - 2 years

COMPLEXITY OF THERAPEUTIC DISCOVERY PIPELINE TIME FOR A PARADIGM SHIFT

Adapted from Barnes, L., AAIC 2020

Hill, Perez-Stable, Anderson, Bernard, Ethn Dis 2015

While traditional risk factors studied in predominantly White samples provide useful information for understanding

disparities, we must incorporate “lived experiences” of diverse participants

Over 350,000 Users

alz.org/trialmatch

300+ Clinical Studies at 500+ Locations

TrialMatch is a free clinical studies matching service designed to provide a customized list of potential study matches to each user.

HOW TO GET INVOLVED IN RESEARCH

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https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/cognitive-impairment-in-older-adults-screening

Resources from ALZ

https://www.alz.org/professionals/health-systems-clinicians/clinical-resources/cognitive-assessment-tools

https://www.alz.org/professionals/health-systems-clinicians/clinical-resources/cognitive-assessment-tools

Resources from ALZ

Resources: https://www.nia.nih.gov/health/assessing-cognitive-impairment-older-patientshttps://knightadrc.wustl.edu/About_Us/PDFs/AD8form2005.pdfhttp://mini-cog.com/wp-content/uploads/2015/12/Universal-Mini-Cog-Form-011916.pdf

Resources from NIA

Providing Better Care: Care Management• Care management can reduce costs throughout course of disease

• Two pilot programs show potential of ongoing care management

Alzheimer’s & Dementia Care Program (UCLA)

$2,400 less in health care spending per patient, per year

33% reduction in nursing home placement

Did not reduce hospitalizations, but reduced intensity of care needed

Health Aging Brain Center Program (Indiana)

$3,474 less in health care spending per patient, per year

Nearly 6:1 return on investment

Reduced hospitalizations and emergency room visits

Sources:Left Box: “Healthy Aging Brain Center Improved Care Coordination and Produced Net Savings,” Health Affairs, 2014Right Box: “Health Care Utilization and Cost Outcomes of a Comprehensive Dementia Care Program for Medicare Beneficiaries,” JAMA Internal Medicine, 2019

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• Better, more personal decision-making

• Better management of comorbid conditions

• Legal, financial, long-term and end-of-life care

• Safety

• Knowing what to expect, coping

Care Planning

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• “I am the care plan.”

• “Hearing it all just once does not work.”

• “It is everything. It grounds you. It takes a bit of the burden of this disease off your shoulders.”

• “[Care plans] include the resources and supportive services that are just as important as medical services.”

• “Information is power over this disease.”

People Need and Want Care Plans

From the Alzheimer’s Association Advocates

Care Planning Toolkit

• Suggested evaluation tools

• Medication review

• Safety, caregiver assessments

• End-of-life discussion

• Code FAQs

• alz.org/careplanning

Brain Changes

Biomarkers

Therapies

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Amyloidβeta

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Immune Function

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Cell Communications

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VascularContributions

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Other

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Tau

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CSF, PET Imaging, Plasma,

etc.

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CSF, PET Imaging, Plasma,

etc.

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CSF, PET Imaging, Plasma, etc.

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CSF, PET Imaging, Plasma,

etc.

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CSF, PET Imaging, Plasma,

etc.

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CSF, PET Imaging, Plasma, etc.

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Rx ?

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Alzheimer’s Disease

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Modifiable Risk Factors

Adapted from R. Petersen, Neurology 2018 91(9)

2015

2025

2050

5.7million people

expected to develop Alzheimer’s in 2050 would not.

If we develop a treatment by 2025 that delays the onset of Alzheimer’s by just 5 years…

CHANGING THE TRAJECTORY OF ALZHEIMER’S DISEASE:

Delayed Onset