Advisory Council September 2011 Meeting Presentation: Opportunities and Gaps



Tuesday, September 27, 2011


Opportunities and Gaps


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 individual’s 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
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 Alzheimer’s disease.
  • Evidence is insufficient to support the use of pharmaceutical agents or dietary supplements to prevent cognitive decline or Alzheimer’s disease.
  • No “highly reliable consensus-based diagnostic criteria for cognitive decline, mild cognitive impairment and Alzheimer’s,” and available criteria at clinician level are not “uniformly applied,” has been addressed.

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

Administration on Aging and National Institute on Aging Collaborations

Program Logo
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.


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.

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


Clinical Care

Identifying Gaps & Opportunities

  • Potential for achieving program goals
  • Service or project is supported by evidence
  • Actionable
  • Need not be specific to Alzheimer’s 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
    • home safety
    • driving
  • 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


Long-Term Services and Supports

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  
  • 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.
  • 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 Down’s Syndrome have deposits in their brains consistent with a diagnosis of Alzheimer’s by the time they are 35-40 years of age. Dementia capable services for this "younger-onset" population are not widely available.
  • 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.
  • 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.



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Advisory Council on Alzheimer's Research, Care, and Services Page

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