ADVISORY COUNCIL ON ALZHEIMER'S RESEARCH, CARE, AND
SERVICES
Opportunities and Gaps
PDF Version:
http://aspe.hhs.gov/daltcp/napa/092711/Mtg1-Slides3.pdf
(15 PDF pages)
P.L. 111 - 148, Patient Protection and Affordable Care Act
Sec. 4103: Medicare Coverage of Annual Wellness Visit Providing a
Personalized Prevention Plan
- Detection of any cognitive impairment is specifically
listed as an element in the law.
- Required as part of the AWV by the Centers for Medicare and Medicaid
Services (CMS) Medicare.
- Effective 01/2011
Detection of Any Cognitive Impairment
P.L. 111-148, Sec. 4103
- Assessment of an individuals cognitive function by direct
observation, with due consideration of information obtained by way of patient
report, concerns raised by family members, friends, caretakers, or others.
- Public commenters noted that this definition was vague and suggested
adding a standardized screening tool.
CMS Questions
Courtesy of Joseph Chin, M.D.
CMS, Office of Clinical Standards
& Quality
- How should we detect any cognitive impairment?
- Is there an evidence-based assessment tool that could be used during
the annual wellness visit?
- sensitive and specific (to limit over-diagnosis)
- applicable to Medicare beneficiary population
- no cost
- time to administer
- Are there recommendations on referrals and follow-up of individuals
identified with cognitive impairment?
- inappropriate and/or ineffective treatments
Evaluation of Cognitive Screening Instruments
- Detection of cognitive impairment provision effective
1/2011
- February 23, 2011, NIH hosted a meeting with CMS and other federal
agencies to discuss the new legislation and cognitive screening.
- On April 4, second meeting held with professional organizations and
federal agencies to determine next steps.
- NIH recently completed a comprehensive review of over 140 published
cognitive screening instruments.
- Next meeting (10/31/2011) scheduled to review instruments and make
recommendations.
ADRD Federal Agencies
Research Planning, Priority Setting, and
Evaluation
- Processes ensure that research programs and priorities are
established, evaluated, and support the most promising research.
- Agencies processes include:
- Established peer-review/external expert reviews of research
programs and funding opportunities
- Participation in and sponsorship of research and state of the
science conferences
NIH State-of-the-Science
Conference Preventing Alzheimer's Disease and Cognitive
Decline |
![Conference Poster](Mtg1-Slides3-fig1.JPG) |
April 26-28,
2010 Bethesda, Maryland |
Scientific Knowledge Gaps
- Firm conclusions cannot be drawn about the association of any
modifiable risk factor with cognitive decline or Alzheimers disease.
- Evidence is insufficient to support the use of pharmaceutical agents
or dietary supplements to prevent cognitive decline or Alzheimers
disease.
- No highly reliable consensus-based diagnostic criteria for
cognitive decline, mild cognitive impairment and Alzheimers, and
available criteria at clinician level are not uniformly applied,
has been addressed.
- http://consensus.nih.gov/2010/alzstatement.htm
Federally Funded Clinical Trials
- Over 40 active clinical trials (pilot and large scale) testing wide
range of interventions
- to prevent,
- to slow, or treat AD and/or MCI,
- to improve care delivery and patient/caregiver outcomes.
- Primary Prevention: of the 10 primary prevention trials, 2 are
NIA-funded cognitive/AD measure add-ons to large NIH primary prevention trials
that address a variety of other primary outcomes.
ADRD FY 2011 Translational Research
Department of Veterans' Affairs
HX-11-014, Targeted Solicitation for Research Projects on Caregiver
Programs and Practice to Improve Care Delivery for Veterans; Release date
March 31, 2011
http://vaww.research.va.gov/funding/docs/HSRD-HX-11-013.pdf
HX-11-013, Targeted Solicitation for Research Projects on Customizing
Long Term Care Programs and Practice to Meet Veterans Needs in the 21st
Century; Release date March 31, 2011
http://vaww.research.va.gov/funding/docs/HSRD-HX-11-014.pdf
Administration on Aging and National Institute on Aging
Collaborations
PA-11-123, Translational Research to Help Older Adults Maintain their
Health and Independence in the Community (R01); Release date- February 16, 2011
http://grants.nih.gov/grants/guide/pa-files/PA-11-123.html
PA-11-124, Translational Research to Help Older Adults Maintain their
Health and Independence in the Community (R21), Release date- February 16, 2011
http://grants.nih.gov/grants/guide/pa-files/PA-11-124.html
![Program Logo](Mtg1-Slides3-fig2.JPG) |
Supported by the
National Institute on Aging and the National Institute on Nursing
Research |
Promoting Adoption of REACH Interventions
- The Department of Veterans Affairs has implemented
REACH-VA through its home health agencies
- Administration on Aging has used REACH in its Funding Opportunity
Announcements as a model for its caregiving demonstration projects
- REACH-Hong Kong
AoA New Research Programs for 2011
- Accelerating Integrated, Evidence-Based, and Sustainable
Service Systems for Older Adults, Individuals with Disabilities and Family
Caregivers
- Creating Dementia Capable, Sustainable Service Systems For
Persons With Dementia And Their Family Caregivers.
To
develop and operate integrated long-term service and support systems that are
dementia capable.
To ensure that older adults, individuals with
disabilities and family caregivers have clear and ready access to a
sustainable, integrated system that offers a comprehensive set of high quality,
evidence-based services that can help them remain independent and healthy in
the community.
Dominantly Inherited Alzheimer Network (DIAN)
Sites: Washington Univ, B&W/MGH/Brown Univ, Columbia Univ, Indiana
Univ, UCLA, ION/UCL, Astralian Consortium
- Establish an international registry of mutation carriers and
non-carriers from families with early onset AD
- Compare carriers and non-carriers to determine the chronology and
order of imaging and biomarker changes that predict symptomatic AD
- Compare the clinical and pathological phenotypes of dominantly
inherited AD with those of Late-Onset AD (LOAD) Study
- Maintain a publicly available resource of data and biospecimens
Alzheimer's Disease Neuroimaging Initiative Public-Private
Partnership |
![Logos of Companies in ADNI Partnership: Abbott; elan; Lilly; Alzheimer's Association; Genentech; GE; MEDPACE; GSK; Pfizer; Novartis; Innogenetics; Roche; AstraZeneca; Alzheimer's Drug Discovery Foundation; Bristol-Myers Squibb; Bayer HealthCare; Schering-Lough; Synarc; Wyeth; Johnson&Johnson; Eisai; Foundation for the National Institutes of Health.](Mtg1-Slides3-fig3.JPG) |
|
Alzheimer's Disease (AD) Translational Research Initiative:
From Drug Discovery to Clinical Trials |
![Flow Chart: Target Discovery Basic Research; leads to Target Validation; leads to Assay Development, Screening Hits to Leads PAS 10-151 (R21); leads to Lead Selection and Optimization PA 10-205 (U01); leads to IND-enabling Toxicology Contract Services; leads to IND; leads to Clinical Development -- AD Pilot Clinical Trials, PAR 11-100 (R01), AD Cooperative Study (U01), Investigator Initiated Clinical Trials (R01); leads to Successful Therapeutic Intervention for AD. IND also leads to Industry. Currently Funded NIH Clinical Trials -- Prevention trials (primary and secondary): 14 (9 pharmacological, 4 behavioral, 1 combined pharmacologic and behavioral), Treatment/Biomarker/Feasibility trials: 24 (17 pharmacologic, 7 behavioral); leads to Clinical Development.](Mtg1-Slides3-fig4.JPG) |
NIA-Alzheimer's Association Project to Redefine Diagnostic Criteria for
Alzheimer's Disease
Overall Goals
- To better define the natural history of Alzheimer's disease from
asymptomatic stages to full blown dementia
- To attempt to relate the clinical symptoms, as they emerge, to the
underlying pathophysiology
- To use present knowledge to better diagnose the disease
- To define a research agenda that will help to extend our knowledge to
better reach these goals
Identifying Gaps & Opportunities
- Potential for achieving program goals
- Service or project is supported by evidence
- Actionable
- Need not be specific to Alzheimers disease
Direct Clinical Services
- Effective early clinical recognition
- Initiating diagnostic testing early
- Appropriate clinical management
Home & Community-based
- Case management services
- Personal Care/Unskilled Care and Respite Care
- Identifying & mitigating unsafe behaviors
- Mobilizing health care benefits (e.g. hospice)
- Securing health care agents and care planning
Education and Outreach for Patients, Families and Providers
- Health care provider training to enrich workforce skills
- Management options
- Case management to improve access and utilization of resources
- Patients and Families
Opportunities and Gaps: Preliminary
- More information about individuals and caregivers use of
services
- Dementia capable service systems
- Needs of special populations
- Training needs
- Outreach to individuals and caregivers
Gaps and Opportunities:
Examples |
Gap |
Data |
- LTSS data at both the federal and state levels
are not readily available to ascertain the numbers of individuals with
Alzheimer's who are receiving Medicaid home and community-based
services.
|
Dementia-Capability |
- Many programs or systems offering home and
community-based services are not skilled at identifying people with dementia;
knowledgeable about the kinds of services that help people with dementia and
their caregivers; and/or capable of providing linkages to other
organizations.
|
Special
Populations |
- Most individuals with Downs Syndrome
have deposits in their brains consistent with a diagnosis of Alzheimers
by the time they are 35-40 years of age. Dementia capable services for this
"younger-onset" population are not widely available.
|
Training |
- Physicians, nurses, allied health
professionals, assessors, service coordinators, quality assurance staff, and
direct care workers often lack specific training in how to identify dementia,
the special needs of persons with dementia and their caregivers, the
progression of the disease, the role of caregivers and how to support
self-direction for this group.
|
Outreach |
- Caregivers of persons with dementia are often
reluctant to identify and seek treatment for depression. Awareness of available
programs may help caregivers cope with behavioral health issues they
experience.
|
Discussion
Where to?
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Disability, Aging and Long-Term Care Policy (DALTCP)
Assistant Secretary for Planning and Evaluation
(ASPE)
U.S. Department of Health and Human
Services (HHS)
Last updated: 09/30/2011