understanding alzheimer’s disease: a review of medical advancements and efforts to address the...
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UNDERSTANDING ALZHEIMER’S DISEASE: A REVIEW OF MEDICAL ADVANCEMENTS AND
EFFORTS TO ADDRESS THE SOCIETAL, ECONOMIC, AND PERSONAL TOLL OF AN IMPENDING PUBLIC
HEALTH CRISIS
Malaika K. Singleton, Ph.D.
Presentation to the Alzheimer’s Disease and Related
Disorders Advisory Committee
California Health & Human Services Agency
September 18, 2013
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OUTLINEO
rigin of Report
P
art 1: Alzheimer’s Disease: Diagnosis, Prevention, and Treatment
P
art 2: Alzheimer’s Disease in California: The State’s Changing
Demographics, the State Plan, and Other Resources to Address
Alzheimer’s Disease
P
art 3: The Federal Response to Alzheimer’s Disease: A National Plan to
Prevent
and Effectively Treat Alzheimer’s Disease by 2025
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ORIGIN OF REPORT
S
enate Office of Research• Nonpartisan office established in 1969 to serve the
research needs of the Senate• Respond to research requests from member offices and
committees• Responses include e-mail, memorandums, briefing papers,
and published reports• Prepare background info for the Senate Rules Committee
to review for the confirmation of Governor appointees to state agencies, boards, and commissions
• I volunteered to write this report while a Science and Technology Policy Fellow in 2010
• Legislative interest and sponsorship for investigating the use of antipsychotic drugs in nursing homes
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PART 1: ALZHEIMER’S DISEASE: DIAGNOSIS, PREVENTION, AND TREATMENT
D
efinitions and Background• Dementia• Alzheimer’s Disease (AD)• Risk Factors & Prevention
N
ew Criteria for Diagnosis: Three Stages of AD• Preclinical• Mild Cognitive Impairment• Dementia Due to Alzheimer’s Disease
H
ow Is AD Treated?• FDA-approved drugs• Non-pharmacological approaches• Antipsychotics
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DEMENTIAV
ascular dementia• Multi-infarct, post-stroke dementia• Impaired judgment and ability to plan
D
ementia with Lewy Bodies (DLB)• Alpha-synuclein aggregates• Sleep disturbances, hallucinations, motor problems
F
rontotemporal lobar degeneration (FTLD)• Front and side regions of the brain• Changes in behavior, personality, difficulty with language
M
ixed dementia
P
arkinsons’s disease• Problems with movement; similar dementia to DLB or AD• Alpha-synuclein aggregates
C
reutzfeldt-Jakob disease• Infectious, misfolded protein (prion) causing malfunction• Impaired memory, coordination, and behavioral changes
N
ormal pressure hydrocephalus• Build-up of fluid in the brain; difficulty walking, memory loss, and urinary incontinence
“Alzheimer’s Disease Facts and Figures in California”, 2009
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M
ost common type of dementia (60 – 80%
of cases)
A
progressive and ultimately fatal brain
disorder characterized by memory loss
(recent events), behavioral changes, and loss
of other functions, including language,
decision-making, walking, and swallowing.
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th leading cause of death in CA as of 2010,
after heart disease, cancer, cerebrovascular
disease, and respiratory disease
ALZHEIMER’S DISEASEAD Hallmarks/Biomarkers
Biomarkers = naturally occurring, measurable substances that can reliably predict the presence, absence, and severity of disease.
Coloradodementia.org
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RISK FACTORS FOR AD
Age• Prevalence doubles every 5 years beyond age 65• Prevalence reaches 50 percent for those 85 and over• However, AD is not normal aging, and evidence suggests that
a healthy lifestyle, higher levels of education, cognitive activity, and other factors could prevent some cases of AD.
Inherited Genetic Factors• Mutations in genes involved in amyloid beta processing (seen
in familial early onset cases)• Variation in a gene (apolipoprotein) that produces a protein
essential for clearing cholesterol and other molecules out of the bloodstream — seen in the general population (sporadic AD cases)
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NEW CRITERIA FOR AD DIAGNOSIS
In 2011, the criteria were updated for the first time in 27
years since the criteria was initially established in 1984.
Guidelines establish 3 stages of the disease with a
spectrum between and within each stage.
Guidelines emphasize new research methodologies and
provide a framework for studying and characterizing the
disease in earlier stages; critical for prevention and
treatment.
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THREE STAGES OF AD Preclinical AD
• Can last up to a decade or more before any symptoms of memory loss and cognitive dysfunction are apparent
• Undetected AD hallmarks revealed during autopsy
• Now used as biomarkers to diagnose living individuals
Mild Cognitive Impairment• Concerns and evidence of cognitive
impairment• Preservation of independence and social
and occupational functioning• Symptoms mild enough to rule out
dementia
Dementia Due to AD• Substantial declines in cognition and
behavior that affect the ability to function independently
Sperling et al., 2011
From a 7/18/2013 Sacramento Bee article titled, “Some Sense Signs of Disease”•Some people complain of memory problems but perform well on neuropsychological and memory tests•Research suggest they are more likely to have AD pathology and develop MCI (56% more likely to be diagnosed in one study) and dementia later•New category considered, “Subjective Cognitive Decline”
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Individual/Informant Reports
Cognitive, Episodic Memory, and Neuropsychological testing
Brain Imaging
Genetic Testing
Cerebrospinal fluid• Amyloid
• Less in the CSF, more in the brain = evidence of AD
• Tau• More in the CSF, less intact in the brain =
evidence of AD
Blood test for miRNA (novel; more research needed)• Regulates gene expression; 12 involved in proper
development of neurons and nervous system• Can differentiate between healthy, AD, and other
diseases
TOOLS USED IN THE DIAGNOSIS OF MCI AND AD
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Grundman et al., 2013
www.mayo.edu
Positron Emission Tomography (PET)
Magnetic Resonance Imaging (MRI)
HOW IS AD TREATED?
California Workgroup on Guidelines for Alzheimer’s
Disease Management recommends:• Pharmacology to treat cognitive decline and memory loss• Appropriate structured activities for recreation and
exercise• Nonpharmacological approaches to address changes in
mood and behavior, followed by pharmacological approaches, if necessary
• Treatment for comorbid (coexisting) conditions• End-of-life care
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TREATING AD: FDA-APPROVED DRUGS
Five FDA-approved drugs to temporarily slow the worsening of
memory loss and cognitive decline
Acetylcholinesterase Inhibitors• Donepezil (Aricept), galantamine (Razadyne), rivastigmine
(Exelon), and tacrine (Cognex—discontinued in the U.S.)• Help maintain the brain’s level of acetylcholine, a
chemical involved in memory
N-methyl-D-aspartate (NMDA) receptor antagonist • Memantine (Namenda)
• Blocks glutamate activity (a chemical involved in learning and memory) to prevent excitotoxicity in the brain
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NON-PHARMACOLOGICAL APPROACHES
The recommended first step to treat behavioral and
psychiatric symptoms associated with Alzheimer’s• Sleep disturbances, verbal and physical outbursts,
hallucinations, and delusions
Environment modification, task simplification,
appropriate activities, and seeking support from
social services or support organizations
Example: Modifying day/night time activities and
behaviors to address sleep disturbances
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ANTIPSYCHOTIC DRUGS
Suggested last resort to treat behavioral and psychiatric
problems
Doctors have discretion to prescribe “off-label”
Serious side-effects (FDA black-box warning)— adverse
cerebrovascular events and increased risk of death in the
elderly
Some modest benefits based on some clinical trials, but
more research is needed due to safety and efficacy concerns
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PART 2: ALZHEIMER’S DISEASE IN CALIFORNIA: THE STATE’S CHANGING DEMOGRAPHICS, THE STATE PLAN, AND OTHER
RESOURCES TO ADDRESS AD
California’s Demographics
Challenges• Caregivers• AD & Dementia: Medi-Cal Costs• Health Care Costs• Additional Challenges
State Plan• Goals and Recommendations for 2011–2021
Resources• Alzheimer’s Disease Centers• California Institute for Regenerative Medicine• Other Programs and Services
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CALIFORNIA’S DEMOGRAPHICS
Currently an estimated
480,000 cases or 11.2%
of those age 65 and over
Estimated 37.5%
increase in AD cases
between 2010 and 2025,
in comparison to a 9%
increase between 2000
and 2010
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CHANGES IN CA DEMOGRAPHICS
4.2 million seniors (age 65 and over) and one-tenth of the
nation’s AD patients—more than any other state
The first wave of baby boomers (born between 1946–
1964) turned 65 in 2011, the age when the likelihood for
AD begins to double every five years
While Caucasians will see the largest absolute growth in
AD cases, the proportional increase relative to the entire
Caucasian population will not be as steep as that seen in
other ethnic groups
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CA DEMOGRAPHICS AND DISPARITIES
AD cases are estimated to triple among Latinos and
Asians and double among African Americans (age 55
and older) by 2030• Large number of baby boomers and social, health,
environmental, and genetic risk factors• Education levels• Chronic health conditions (diabetes and heart
disease)• Access to health care and clinical trials (challenges
include: immigration status, bias in screening and assessment, and level of comfort with clinician)
• Cultural competency issues (i.e. language access)
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CHALLENGES: AD CAREGIVERS
Traditionally the wives or adult daughters of individuals with AD
75% of individuals with AD are cared for at home
Emotional, physical, and financial impacts• Mental health disturbances• Health difficulties• Decline in work productivity and attendance, which impact job
security and benefits
Broader societal and economic impacts as the value of unpaid
care, cost for formal services, Medicare, and Medicaid continue
to rise
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DEMENTIA DOG PROJECT
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• Supported by Alzheimer Scotland, the Glasgow School of Art, Dogs for the Disabled, and Guide Dogs
• Fetch medicine in response to an alarm
• Take items between the individual and caregiver
• Relieve stress for both
dementiadog.org
AD AND DEMENTIA: MEDI-CAL COSTS
According to one estimate
(in 2007 dollars), Medi-Cal
costs are 2.5 times greater
for individuals with AD and
other dementias compared
to those without
Costs are driven primarily by
nursing home expenditures,
which are about 3 times
greater for AD and dementia
21
“Alzheimer’s Disease Facts and Figures in California”, 2009
CHALLENGES: HEALTH CARE COSTS
Changes, reductions, and elimination of programs due to the
state’s recent fiscal crisis• In-Home Supportive Services• Adult Day Health Program to Community-Based Adult Services
Program
Opportunities for reform• Coordinated Care Initiative• The Excellence in Dementia Care Project in San Francisco
• Includes full-time dementia support nurse, 24-hour help line, consultation services, and training existing caregivers for crisis prevention and to reduce emergencies
• ~40% reduction in emergency room services and potential for cost-savings
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ADDITIONAL CHALLENGES
Long-term care services and support• Ability to pay is an issue since Medicare and private
insurance plans do not cover• Medicare covers limited skilled nursing facility and home
health care services but not respite or custodial care, which is what many individuals with dementia (and their caregivers) need
• Supplemental policies are limited and expensive• Medi-Cal, which covers skilled nursing facility stays,
including custodial care, has eligibility requirements (family income and age)
Workforce• Shortage of formal caregivers and health care
professionals with geriatric training
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CA ALZHEIMER’S DISEASE STATE PLAN
10-year action plan
6 categories of goals and
recommendations
Published March 9, 2011
The first of 5, 2-year action plans was
published in June 2011 and focused
on 3 of the 6 goals
Alzheimer’s Disease and Related
Disorders Advisory Committee and
others within the task force are
assessing the implementation of the
plan
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“California’s State Plan to Address Alzheimer’s Disease”, 2011
RESOURCES: CA ALZHEIMER’S DISEASE CENTERS
Since 1985, the state has invested more than $90 million in 10 university-
based centers, which raised over $500 million in federal and private research
funding.
Due to the state’s recent fiscal crisis, funding was reduced by 50% and
research and data collection were discontinued in 2009.
The centers evaluate a minimum of 100 new patients per year, but
comprehensive, multidisciplinary diagnostic and treatment evaluations were
eliminated; follow-up contact for each newly evaluated patient, complete
follow-up reevaluations for all existing patients, clinical follow-up services,
and long-term follow-up services were discontinued.
Services offered by the centers include: professional training, specialty
referral clinics, education and community services, research funding, and
specialized knowledge provided to committees and task forces.
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RESOURCES: CA INSTITUTE FOR REGENERATIVE MEDICINE
Established in 2004 following the passage of Proposition 71,
the California Stem Cell Research and Cures Initiative.
Prop. 71 provided $3 billion in bond funding for stem cell
research at CA universities and other research institutions
and established a stem cell agency to provide grants and
loans to fund research focused on discovering and
developing cures, therapies, diagnostics, and technologies
to alleviate suffering from disease.
The site currently lists 7 grants targeting Alzheimer’s
disease for a total of ~$26 million of funding.
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RESOURCES: PROGRAMS & SERVICES
See page 40 of the report for a list of programs
and services offered from the:• Department of Aging• Department of Health Care Services• Department of Social Services• California Health and Human Services Agency
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PART 3: THE FEDERAL RESPONSE TO ALZHEIMER’S DISEASE: A NATIONAL PLAN TO PREVENT AND
EFFECTIVELY TREAT ALZHEIMER’S DISEASE BY 2025
N
ational AD Demographics
D
ementia Costs to the Nation
L
egislation and National Plan
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NATIONAL AD DEMOGRAPHICS
Estimated 5.2 million Americans living with AD;
expected to rise to 7 million by 2025
AD is 6th leading cause of death across all ages; 5th
leading cause of death for those over age 65
1 in 3 seniors dies with some type of dementia
Older individuals living with AD could reach an
estimated 13.8 million to 16 million by 2050
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DEMENTIA COSTS TO THE NATION (RAND STUDY)
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• Formal and informal caregiving cost = $159 billion to $215 billion in 2010
• Expected to reach $379 billion to $511 billion by 2040
• 75% to 84% due to nursing home and home-based LTC, rather than medical services
• Direct Care Cost• Dementia = $109 billion (estimated
cost in 2010)• Heart Disease = $102 billion (in 2010
dollars)• Cancer = $77 billion (in 2010 dollars)
FEDERAL LEGISLATION & NATIONAL PLAN
National Alzheimer’s Project Act • Signed into law in 2011• Requires the creation of a national plan to address AD and coordinates AD efforts
throughout the federal government• Established the Advisory Council on Alzheimer’s Research, Care, and Services
• Charged with holding quarterly public meetings and producing an annual report• First report with set of recommendations was released in April 2012 and was
updated in January 2013
National Plan to Address Alzheimer’s Disease (released in May 2012 and updated June 2013)• Goal 1: Prevent and Effectively Treat AD by 2025• Goal 2: Enhance Care Quality and Efficiency• Goal 3: Expand Supports for People with AD and Their Families• Goal 4: Enhance Public Awareness and Engagement• Goal 5: Improve Data to Track Progress
Immediate Actions Taken (in 2012): Increased NIH funding for AD research and clinical trials
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2013 UPDATE TO NATIONAL PLAN
Identified actions completed, updated, and new
actions to meet the plan’s goals• Example (Completed): Review evidence on care
coordination models for people with Alzheimer’s disease (report is scheduled to be released in August 2013)
• Example (Updated): Regularly convene an Alzheimer’s disease research summit to update priorities• First held in May 2012, second planned for 2015
• Example (New): Develop and disseminate a unified primary care Alzheimer’s disease curriculum• Will involve partnering with Alzheimer’s Disease Centers
(ADCs)
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SUMMARY HIGHLIGHTS
AD diagnosis and treatment is evolving due to
medical advancements and ongoing research
State, federal, and local resources available• Coordination is key and is a shared goal
State and National Plan to Address AD (and San
Francisco)• Both being continuously evaluated and updated
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REFERENCESA
lzheimer’s Disease Facts and Figures in California, 2009• http://www.alz.org/cadata/fullreport2009.pdf
2
013 Alzheimer’s Disease Facts and Figures• http://www.alz.org/downloads/facts_figures_2013.pdf
“
Some Sense Signs of Disease”, Sacramento Bee, July 18, 2013• http://www.sacbee.com/2013/07/18/5574935/some-sense-signs-of-disease.html?storylink=lingospot
h
ttp://dementiadog.org/
“
Amazing Dog Trained To Help People With Dementia ‘Has Given Them Their Life Back’• http://www.huffingtonpost.co.uk/2013/07/15/dementia-dog-training_n_3597470.html
“
'Dementia Dogs' Begin Work, Already Making A Difference With Their Owners In Scotland” (PHOTO) • http://www.huffingtonpost.com/2013/07/18/dementia-dogs-help-owners-in-scotland_n_3605444.html?utm_hp_ref=tw
“
S.F. Alzheimer's Pilot Results Released”• http://www.californiahealthline.org/capitol-desk/2013/7/results-out-for-alzheimers-pilot-plan-in-sf
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REFERENCES CONTINUED
“California’s State Plan for Alzheimer’s Disease: An Action Plan for 2011–2021”• http://caalz.org/PDF_files/CA%20State%20Plan.pdf
California Alzheimer’s Disease Centers• http://cadc.ucsf.edu/cadc/
California Institute for Regenerative Medicine, Alzheimer’s Disease Fact Sheet• http://www.cirm.ca.gov/about-stem-cells/alzheimers-disease-fact-sheet
“Monetary Costs of Dementia in the United States”• http://www.nejm.org/doi/pdf/10.1056/NEJMsa1204629
National Alzheimer’s Project Act• http://aspe.hhs.gov/daltcp/napa/
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