advancing the science: the latest in alzheimer’s and dementia … · 2021. 1. 13. · early-onset...
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Rebecca Edelmayer, Ph.D.Director, Scientific EngagementMedical & Scientific Relations
Advancing the Science: The Latest in Alzheimer’s and Dementia Research
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• I have no disclosures.• I am a full time employee of the Alzheimer’s
Association.
DISCLOSURES
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Our mission is to lead the way to end Alzheimer's and all other dementia —by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support.
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• Landscape of Alzheimer’s and Dementia Science• Highlights in Early Detection and Diagnosis• Latest Advances in Clinical Trials, Treatments and
Lifestyle Interventions
OUR TIME TODAY
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• Almost two-thirds of Americans with Alzheimer’s are women.
• Older African Americans and Hispanics are more likely, on per-capita basis, than older whites to have Alzheimer’s.
• Mostly due to health, lifestyle and socioeconomic risk factors
*2019 Alzheimer’s Disease Facts and Figures
GENDER, RACIAL AND ETHNIC DIFFERENCES IN ALZHEIMER’S PREVALENCE
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• Allows the results to be a representation of the general public
• To investigate potential biological differences across diverse groups and their effects on drug efficacy and adverse events
• To identify socio-economic, behavioral and cultural risk factors
DIVERSITY IN CLINICAL TRIALS AND DEMENTIA RESEARCH
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• Dementia is a collection of symptoms related to cognitive decline
• Can include cognitive, behavioral and psychological symptoms
• Due to biological changes in the brain• Alzheimer’s is most common cause• Mixed dementia is very prevalent• Some causes of cognitive decline are
reversible and not truly dementia
60%-80%
10%-40%~ 10%
10%-25%
~ 50%
DEMENTIA IS A SYNDROME
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Cognitively Unimpaired
Mild Cognitive
ImpairmentMild
DementiaModerate Dementia
Severe Dementia
MCI is a known risk factor for dementia
Everyone who experiences dementia passes through MCI
When you prevent new cases of MCI, you are preventing new cases of dementia
Impairment does not interfere with activities of daily living
Impairment in two or more cognitive functions that interfere with activities of daily living
CONTINUUM OF COGNITIVE IMPAIRMENT
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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.
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Resources from ALZ
https://www.alz.org/professionals/health-systems-clinicians/clinical-resources/cognitive-assessment-tools
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https://www.alz.org/professionals/health-systems-clinicians/clinical-resources/cognitive-assessment-tools
Resources from ALZ
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By working with the Alzheimer’s Association, your network will gain the knowledge and tools needed to:
assess cognition,
provide a timely diagnosis of Alzheimer’s or other dementias,
and receive the support required to direct patient management, including quality care.
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HIGHLIGHTS IN BIOMARKERS
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Cognitively Unimpaired Alzheimer’s Dementia
Biomarkers History & Cognition
MODERNIZING THE DIAGNOSIS
20years or more before symptoms appear,
the brain changes of Alzheimer’s may begin.
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BIOMARKERS ARE CHANGING THE GAME
Biofluid Analysis Emerging MarkersBrain Imaging
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National study on utility of amyloid PET scans~18,500 Medicare beneficiariesWith mild cognitive impairment (MCI) or dementia of uncertain cause
Aim 1: Impact of scan on care management planAim 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
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• Recruit diverse cohort of 7,000 Medicare beneficiaries– At least 2,000 Black/African-American and 2,000
Hispanic/Latino– Early-onset and late-onset dementia– Typical and atypical clinical presentations of AD– Biorepository (DNA and plasma) and image archive
• Study approved by CMS 4/23/2020– Starting Fall 2020 enrollment, COVID-19 permitting– Approximately 350 sites, 3 years enrollment– Website: IDEAS-Study.org
NEW IDEAS: A STUDY TO IMPROVE PRECISION IN AMYLOID PET COVERAGE AND PATIENT CARE
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FDA REGULATORY REVIEW NEWS
Flortaucipir / Tauvid
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FDA REGULATORY REVIEW NEWS
CSF DiagnosticsLumipulse®G
β-Amyloid Ratio (1-42/1-40)
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• Global race to uncover and develop blood based biomarkers for Alzheimer’s and other dementia
• More research validating amyloid beta and tau in blood by comparing to imaging and cognitive testing
• New research on blood tests for alpha synuclein and neurofilament light
IN THE NEWS
PROGRESS TOWARDS A BLOOD TEST
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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
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ADVANCES IN DRUG TREATMENTS
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Adapted from PhRMA 2018
3 - 6 years 6 - 7 years 0.5 - 2 years
COMPLEXITY OF THERAPEUTIC DISCOVERY PIPELINE
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FDA Approved Therapies for Alzheimer’s
AVAILABLE THERAPIES
Cholinesterase Inhibitorsdonepezil (Aricept) All Stagesrivastigmine (Exelon) Mild – Moderate Stagegalantamine (Razadyne) Mild – Moderate Stage
Glutamate Moderatorsmemantine (Namenda) Moderate – Severe Stage
Combinationdonepezil + memantine Moderate – Severe Stage(Namzaric)
• Currently, there are no therapies that can cure Alzheimer’s
• Some drugs are available to temporarily improve symptoms
• The field is making great progress in developing new and better therapies
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Adapted from Cummings J., et al., 2020
ALZHEIMER’S DRUG DISCOVERY PIPELINE
The total number of participants required for
currently recruiting trials is 31,314
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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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BIOGEN SEEKS FDA APPROVAL FOR ADUCANUMAB
• Aducanumab (Anti-amyloid therapy)– Trial Population: MCI due to Alzheimer’s &
mild Alzheimer’s dementia• Futility Analysis Halted Trial: Mar 2019• Expanded Data Analysis Reported: Dec 2019
– Reduction in clinical decline– Effects on cognition and function– Reduction in amyloid/tau biomarkers
• FDA grants ‘Priority Review’: August 2020• FDA Advisory Board November 6, 2020• FDA decision anticipated: March 2021
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MEDICINES FOCUSED ON BEHAVIORAL AND PSYCHOLOGICAL SYMPTOMS OF DEMENTIA
Pimavanserin (Nuplazid)• Dementia-Related Psychosis• Includes dementia related to Alzheimer’s,
Parkinson’s, Lewy Body, Vascular, Fronto-temporal
• Potential to be 1st FDA-approved psychosis drug in dementia population
• FDA grants ‘Standard Review’: Jul 2020• FDA decision anticipated: Apr 2021
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Suvorexant (Belsomra)• Insomnia• Mild-to-Moderate Alzheimer’s• 1st FDA-approved insomnia
drug in dementia population
MEDICINES FOCUSED ON BEHAVIORAL AND PSYCHOLOGICAL SYMPTOMS OF DEMENTIA
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• Environmental Mediated Factors• Sleep & Circadian Rhythms• Cell Death• Presenilin Biology• Proteostasis/Proteinopathies• Growth Factors and Hormones• Synaptic Plasticity/Neuroprotection• Neurogenesis• Multi-target• Others
• Amyloid Beta• Tau• Vascular• Genetics• APOE & Lipid Neurobiology• Immunity and Inflammation• Metabolism and Bioenergetics• Epigenetic Regulators• Oxidative Stress• Neurotransmitter Receptors
DIVERSE THERAPEUTIC MECHANISMS UNDER INVESTIGATION
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UNDERSTANDING RISK & INTERVENTIONS TO REDUCE RISK
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WHAT MAY IMPACT RISK:
• Age• Genetics• Race / Ethnicity• Environmental and Lifestyle Factors• Cardiovascular Health• Physical Activity• Diet• Sleep• Social / Cognitive Engagement• Education• Traumatic Brain Injury
Need to Study
Dementia Risk from
ALL Angles
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40%Global Dementia May be
Preventable
FOCUS ON RISK REDUCTION 2020*
*Air PollutionTraumatic Brain InjuryExcessive Alcohol Use
The Lancet 2020 Commission on Dementia Report
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Late-lifeMid-lifeAdult-life
Obesity
Hypertension
Dyslipidemia
Neuronal damage
Vascular insultsFirst Degree Family History
Dementia
APOE,other genes
DiabetesUnhealthy diet
Alcohol misuseSmoking Depression
Across the Lifespan
0 20 60 75
Education
Physical Activity Cognitive & Social ActivityAcross the Lifespan
Brain Reserve
Cognitive ReserveProtectiveFactors
Risk Factors
AD Riskimpact on neuron viability, inflammation, oxidative stress, glucose metabolism, endothelial cell damage, clearance of tau and b-amyloid from brain
Importance of Chronic Exposure to Multiple FactorsHEALTHY AND PATHOLOGICAL AGING?
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• Combining 4 or 5 factors 59% lower risk• Combining 2 or 3 factors 39% lower risk• May even offset risk associated with genetics
COMBINING MULTIPLE HEALTHY LIFESTYLE FACTORS
HEALTHY DIET MODERATE TO VIGOROUS PHYSICAL ACTIVITY
LIGHT TO MODERATE ALCOHOL INTAKE
LITTLE TO NO SMOKING COGNITIVE STIMULATION
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Investigating the long-term impact of
exposure to the novel coronavirus (SARS-CoV-2) on the brain, including cognition, behavior
and function.
ALZHEIMER’S ASSOCIATION SARS-CoV-2 INTERNATIONAL RESEARCH STUDY TO UNDERSTAND IMPACT ON THE BRAIN
More Information: http://alz.org/SARS-CoV2-study
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ALZHEIMER’S ASSOCIATION SARS-CoV-2 INTERNATIONAL RESEARCH STUDY TO UNDERSTAND IMPACT ON THE BRAIN
de Erausquin GA et al., A&D 2021: https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12255
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Both observational and interventional studies are needed to translate research findings into community-based programs
Observational StudiesWhat factors increase or decrease our risk for dementia?
Interventional Studies What is the impact of reversing those risk factors?
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• 9,000+ people, Over age 50, All-cause dementia risk
• Standard vs. Intensive Blood Pressure Intervention
• Intensive treatment 120 systolic vs. 140 systolic
• Dramatic reduction of small vessel disease on MRI
First Study to Demonstrate Reduction of New Cases of Cognitive Impairment
THE SPRINT-MIND STUDY 19% REDUCEDrisk for MCI
17% REDUCEDrisk for Dementia
15% REDUCED combined risk for MCI and Dementia
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There are things you can do to reduce your risk of MCI and dementia –especially regarding cardiovascular disease risk factors.
WHY IS THIS IMPORTANT?
Immediate opportunity with life changing impact potential
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• 1260 cognitively healthy60-77 year old adults, at increased risk for cognitive decline due to medical conditions
• 2-year study of Lifestyle Intervention vs. Usual Care
FINGER TRIAL
Cog
nitio
n
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A 2 year study of Lifestyle intervention vs.Usual Care
Interpretation Findings from this large, long-term, randomized controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population.Tiia Ngandu, Jenni Lehtisalo, Alina Solomon, Esko Lefälahti, Satu Ahtiluoto, Riita Antikainen, Lars Bäckman, Tuomo Hänninen, Anti Jula, Tiina Laatikainen, Jaana Lindström, Francesca Mangialasche, Teemu Paajanen, Satu Pajala, Markku Peltonen, Rainer Rauramaa, Anna Stigsdotter-Neely, Timo Strandberg, Jaako Tuomilehto, Hilkka Soininen, Miia Kivipelto
“A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial.” The Lancet. 2015 June 6
Number of subjects: 1260
Cognitively Healthy Adults: with increased risk for cognitive decline due to medical conditions
Age range: 60-77 years
Time: 2 years
MULTIDOMAIN INTERVENTION• Nutrition• Exercise • Cognitive training • Vascular risk monitoring
REGULAR HEALTH ADVICE
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North Carolina Chicagoland
Northern CaliforniaHouston
Rhode Island/New England
Recruiting400 participants
per site
Participants will be randomized into either
Structured or Self-Guided lifestyle groups
Length of study
2000participants
5sites
2interventions
2years
500Randomized
If the interventions prove effective, this study will lead the way in the development of an accessible and sustainable community-based program for prevention
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Physical Activity | Nutrition | Intellectual Engagement | Health Coaching
StructuredLifestyle
Intervention
Differ in format, expectations, and
accountability
A LANDMARK STUDY: TWO LIFESTYLE INTERVENTIONS
Self-GuidedLifestyle
Intervention
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POINTER-Neuroimaging
NIA SUPPORTED ANCILLARY STUDIES |
POINTER-zzz
POINTER-Neurovascular POINTER-Microbiome
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Countries in the planning phase for FINGER-like studies
Currently planning or implementing a FINGER-like study
U.S. POINTER
U.K.FINGER
FINGER
MIND-CHINA
MAINTAIN YOUR BRAIN
AU-ARROW
MIND-AD
GOIDZ-ZAINDUPENSA
LATAM-FINGER
CAN-THUMBS-UP
INDIA-FINGER
J-MINTSUPERBRAIN
SINGER
U.S. POINTER ISN'T ALONE
World-Wide FINGERS is a large,
international network sharing experiences and
data, and is collaborating to
prevent cognitive impairment &
dementia worldwide.
GLOBAL
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2015
20252050
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
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• Alzheimer’s Association is the global leader for Alzheimer’s and dementia science
• Exciting time in research– New tools for detection and diagnosis– Growing diversity of therapies under investigation– New resources and strategies to promote diverse
participation
• New research leading to future of therapy that combines drugs and modifiable risk factor interventions
• There is HOPE in research
IN SUMMARY…
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ALZ.ORG
1-800-272-3900