Connecting the Aging Network, Individuals with Dementia, and Caregivers with Research Opportunities

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Connecting the Aging Network, Individuals with
Dementia, and Caregivers with Research
Opportunities

• July 12, 2012

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welcome

• Michelle Washko, PhD
• Center for Disability and Aging Policy
  Administration for Community Living
• U.S. Department of Health Human Services
• 202-357-3447
• Michelle.Washko_at_aoa.hhs.gov 

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http//www.aoa.gov/AoARoot/AoA_Programs/HPW/Alz_Gr
ants/index.aspxcurrent

• Alzheimers Disease
• Supportive Services
• Program
• Delivers supportive services
• Translates evidence-based models
• Advances state initiatives toward coordinated
  systems of home and community-based care

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Total Active ADSSP Grants
States with DS grants are marked with


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http//www.aoa.gov/AoARoot/AoA_Programs/HPW/Alz_Gr
ants/index.aspxcurrent scroll down to see
Current Projects

• Evidence-Based
• Cooperative
• Agreements
• demonstrate how existing evidence-based
  interventions that help people with ADRD and
  their family caregivers can be translated into
  effective supportive service programs at the
  community level.

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ADSSP Grantee Profiles

• http//www.adrc-tae.org/tiki-index.php?pageadsspm
  ap

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Joint Funding Opportunity Announcement between
NIA-AoA

• Consider partnering to apply for the
  Translational Research to Help Older Adults
  Maintain their Health and Independence in the
  Community (R01/R21)
• See the full announcement at http//grants.nih.gov
  /grants/guide/pa-files/PA-11-123.html

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welcome

• Nina Silverberg, PhD
• Assistant Director
• Alzheimer's Disease Centers Program
• Division of Neuroscience
• National Institute on Aging
• National Institutes of Health
• U.S. Department of Health Human Services
• [phone]
• SilverbergN_at_mail.nih.gov 

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http//www.nia.nih.gov/alzheimers/alzheimers-dise
ase-research-centers

• NIA-funded Alzheimers
• Disease Centers
• ADCs conduct research on all aspects of
  Alzheimers Disease
• Provide diagnosis and education services for
  patients and families
• Opportunities to participate in research

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• Each AD center has
• Administrative Core
• Education Core
• Clinical Core
• Data Core
• Neuropathology Core

• Each also has its own focus,e.g.
• Fronto-Temporal Degeneration
• Specific diverse populations
• Most also conduct clinical trials

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http//www.adcs.org

• Alzheimer's Disease
• Cooperative Study (ADCS)
• NIA-funded collaboration to facilitate the
  discovery, development and testing of new
  Alzheimers treatments
• Conducts large, multi-site trials
• Focus on drugs that might not be developed by
  industry

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More than 70 sites across the US and
CanadaOverlaps with ADCs
Salt Lake City
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Connecting the Aging Network to Clinical
Researchers at National Institute on Agings
Alzheimers Disease Centers
Diana R. Kerwin, MD Assistant Professor Cognitive
Neurology and Alzheimers Disease
Center Northwestern University

• Raj C. Shah, MD
• Associate Professor
• Rush Alzheimers Disease Center
• Rush University

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Disclosures for Diana R. Kerwin, MD

• I received funding and support as the Site PI for
  the Alzheimer Disease Cooperative Studies ADNI
  (NIA U01 AG024904) ,Forrest Laboratories Protocol
  NAM-MD-53-J and Lilly Research Laboratories
  Protocol H6L-MC-LFAN.
• I have served on an Advisory Board for Neuronix
  and Pfizer. I serve on a Speaker Board for
  Novartis Pharmaceuticals.
• I receive funding from the NIA funded CNADC,
  Co-Investigator on NIA U01 AG022376 and support
  from the Illinois Department of Public Health
  Alzheimers Disease Assistance Center Grant.

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Disclosures Raj C. Shah, MD

• I receive or have recently received research
  support from the NIH P30 AG101061 (Education and
  Information Transfer Core Leader), P01 AG009466
  (Co-investigator, Administrative Core), U01
  AG010483 (Site Investigator), U01AG024904 (Site
  Co-investigator), and U01 AG029824
  (Coinvestigator) and from the Illinois
  Department of Public Health Alzheimers Disease
  Assistance Center Grant.
• I receive or have recently received research
  support as Site PI or Site Subinvestigator from
  Ceregene, Inc., Danone Research B.V., Eisai,
  Inc., Elan Pharmaceuticals,Inc., Genentech, Inc.,
  Merck Co., Inc., Metabolic Solutions
  Development Company, Pamlab, L.L.C., Orasi, Inc.,
  and Pfizer, Inc. and
• I serve on the Board of Directors of the
  Alzheimers Association Greater Illinois
  Chapter
• I recently served on a research advisory panel
  for Accera, Inc. and a Clinical Advisory Panel
  for Nutricia North America and serve on a
  research advisory panel for Merck Co., Inc.

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Discussion Points

• Where are the gaps in diagnosing, treating, and
  preventing Alzheimers disease?
• Why we need to do clinical research in
  Alzheimers disease?
• What is clinical research?
• Who needs to be involved in clinical research?
• How can we work together to support clinical
  research?

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The Problem of Alzheimers Disease (AD)

• Dementia due to AD causes significant suffering
• About 5.4 million Americans have dementia due to
  AD
• There are 15 million informal caregivers for
  persons with dementia due to AD
• Dementia due to AD is the third most costly
  disease state behind heart disease and cancer in
  the United States (US)
• Approximately 200 billion will be spent in the
  direct and indirect costs of care in 2012
• AD is the sixth leading cause of death in the US
• By 2050, it is estimated 16 million Americans
  will develop dementia due to AD

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Where are the Gaps in Solving the AD Problem?

• There is no proven prevention strategy.
• There is no simple diagnostic test.
• There is no cure for dementia due to AD
• So, there is a lot of work to do.

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Where are the Gaps in Solving the AD Problem?

• What causes AD?
• What risk factors for AD can be modified?
• Are there markers to identify AD before symptoms
  show up?
• What brings out the symptoms of the AD?
• What are accelerators of dementia due to AD?

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Why We Need to Do Research in AD?

• Alleviating Fear
• Providing Hope
• Clearing a Path
• Giving Direction

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Why We Need to Do Research in AD?

• Preventive
• Prevent buildup of protein changes
• Build brain reserve
• Early changes prior to disease diagnosis
• Delay transition to disease
• Early Disease
• Reverse or halt progress
• Late Disease
• Improve quality of life
• Reduce caregiver burden

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What is Clinical Research?

• This type of research involves a particular
  person or group of people or uses materials from
  humans. This research can include
• Studies of mechanisms of human disease
• Studies of therapies or interventions for disease
• Studies to develop new technology related to
  disease

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What is a clinical trial?

• Clinical trials are used to determine whether a
  medication or behavioral intervention are safe,
  efficacious, and effective.
• This can include medications or an intervention
  to modify behavior (such as diet, physical
  activity, cognitive therapy, etc.)
• Research with human subjects to develop or
  evaluate clinical laboratory tests (imaging or
  molecular diagnostic tests) might be considered
  as a clinical trial if the test will be used for
  medical decision making, or if the test itself
  imposes more than minimal risk for subjects.
  (ADNI study is an example of this)

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Key points about clinical trials

• Although very important, it is research and
  should be considered separate from a clinical
  treatment plan
• In drug studies and other interventions, there is
  a placebo arm that is assigned randomly and
  neither the participant or physician will know if
  the participant receives treatment or placebo
• Clinical research is a commitment of time by the
  participant and family member and the benefits
  are in advancing research and will not
  necessarily directly benefit the participants

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What is Clinical Research?

• A few examples of ongoing studies
• 1. Risk Factors Genetics Initiative
• 2. Diagnostics Alzheimers Disease
  Neuroimaging Initiative 2 (ADNI-2)
• 3. Treatment Resveratrol

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Genetics Initiative

• Purpose of trial To determine the genes that
  play a role in late-life AD, and to learn more
  about the cause of AD how to prevent it. Blood
  samples will be collected from all participants.
• Eligibility Two siblings who developed AD after
  60, and another family member over age 50 with
  memory loss, or a family member over age 60 with
  no memory loss. Participants can live anywhere
  in the US.
• Duration of trial One encounter with every two
  year follow-up

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ADNI-2

• Purpose of trial To determine body fluid,
  genetic, and imaging biomarkers that may predict
  who is likely to develop Alzheimers disease.
• Eligibility Individuals older than age 55 with
  memory concerns and no diagnosis of dementia will
  be followed with evaluations involving blood,
  urine, spinal fluid, and brain imaging and memory
  testing.
• Duration of trial One visit every 6 months.

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Resveratrol

• Purpose of trial To determine if resveratrol
  therapy is better than placebo in delaying or
  altering the deterioration of memory and daily
  functioning in persons with Alzheimers.
• Eligibility Persons over age 50 with an AD
  diagnosis who do not have diabetes or are
  currently taking Coumadin (warfarin).
• Duration of trial Ten evaluations over the span
  of one year.

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Who Needs to Be Involved in Clinical Research for
AD?
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How Can We Work Together?

• Research Centers Providing education about
  clinical research in AD prevention, diagnosis,
  and treatment
• Aging Network Providing awareness and
  acceptance for participation in clinical research
  in AD prevention, diagnosis, and treatment
• Together Connecting potential persons and
  caregivers to research options

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Case ExampleASPirin in Reducing Events in the
Elderly

• Purpose of trial To determine if treatment with
  low-dose aspirin is better than placebo in
  helping healthy older adults achieve
  disability-free longevity (i.e. living longer
  without developing dementia or functional
  disability).
• Eligibility Healthy older persons over age 65
  with no current medical need to be on aspirin
  therapy.
• Duration of trial Annual evaluations for five
  years.

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Case ExampleASPirin in Reducing Events in the
Elderly

• Sponsor National Institute on Aging
• Number of Participants Required 19,000.
• Where Participants Being Recruited 13,000 in
  Australia 6000 in United States.
• Focus in United States Make sure results
  applicable to all healthy older persons of
  various race/ethnicity, including but not limited
  to African-American, Latino, and Asian.
• Sites Over 30 centers in the United States
• More Information www.aspree.org

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How Can We Work Together?

• Research Centers
• Available to give presentations to Aging Network
  staff about what research is about.
• Available to give community presentations
  requested by Aging Network
• Available for questions about research for
  potential participants
• Make it easy to access research options

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How Can We Work Together?

• Aging Network
• Encourage frontline staff to be capable of
  advising clients about research as an option for
  caregivers, persons at risk for AD, and persons
  with AD
• Work with diverse community leaders to break down
  barriers to potential research participation

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How Can We Work Together?

• Research Centers and Aging Network
• Sharing best practices on what works and what
  does not work
• Figuring out efficient ways for link caregivers,
  persons at risk for AD, and persons with AD to
  each group

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How to Actively Connect?

• See and hear next presentations,
• http//www.alz.org (TrialMatch)
• http//www.nia.nih.gov/alzheimers (ADEAR),
• Other options
• Alzheimers Disease Information Network (AD-IN)
  by the NIA Alzheimers Disease Cooperative
  Studys national Information Network at
  http//www.adcs.org
• http//www.clinicaltrials.gov

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Contact Information

• Diana R. Kerwin, MD
• Cognitive Neurology and Alzheimer's Disease
  Center
• Northwestern University
• 645 N Michigan Avenue, Suite 630Chicago, IL
  60611E-mail d-kerwin_at_northwestern.edu
• Clinical office 312-695-9627

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Contact Information

• Raj Shah, MD
• Rush Alzheimers Disease Center
• Rush University Medical Center
• 600 South Paulina, Suite 1022
• Chicago, IL 60612
• E-mail Raj_C_Shah_at_rush.edu

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http//www.nia.nih.gov/alzheimers

• NIAs ADEAR Center Website features
• AD Research Centers
• Clinical Trials
• Alzheimers research news
• Alzheimers topics
• Symptoms, Diagnosis, Treatment, Research, more
• E-alert Sign-up
• Free publications

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http//www.nia.nih.gov/alzheimers/topics/research

• Free Fact Sheet

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http//www.nia.nih.gov/alzheimers/clinical-trials

• NIA ADEAR Search for Alzheimers Clinical Trials
• Find trials by
• Location
• Eligibility criteria
• Drugs tested
• Featured trials
• ADEAR phone support1-800-438-4380
• Sign up to receive e-alerts, RSS when new trials
  posted/updated

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• NIA ADEAR Alzheimers trial detail page
• User-friendly description
• Map and listing of sites with contact information
• Inclusion/exclusion criteria

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http//www.clinicaltrials.gov

• NIH ClinicalTrials.gov
• Registry for almost all clinical trials
• Comprehensive source for other databases
• Searchable

• Screen shot

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http//clinicalresearchtrials.nih.gov/

• NIH Clinical Research Trials and You
• Trans-NIH collaboration to promote research
  participation awareness
• Personal stories from participants, researchers
• Downloadable promo materials (posters, flyers,
  slides) for community education

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https//www.researchmatch.org/

• ResearchMatch
• NIH-funded initiative to connect interested
  research participants with researchers
• Free, secure registry
• Studies contact registry participants when there
  is a match

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• Questions? Contact ADEAR
• Call toll-free1-800-438-4380Mon-Fri, 830
  am-500 pm Eastern Time
• or emailadear_at_nia.nih.gov

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TrialMatch Objectives

• Move science forward towards a world without
  Alzheimers
• Increase the numbers of individuals enrolled in
  Alzheimers trials and studies
• Provide information to the public and healthcare
  professionals to help facilitate Alzheimers
  clinical trial enrollment
• Educate caregivers and people with dementia about
  Association support programs

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Overview How TrialMatch Works

• 1) Individual completes a profile online or over
  the phone. (Person with the disease, healthy
  volunteer, caregiver or physician)
• 2) The database takes the information in the
  profile, compares it to the match criteria housed
  in the database and presents a list of trials
  that are potential matches.

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Overview How TrialMatch Works

• 3) The individual can then select the trials they
  are most interested in and connect with a
  TrialMatch Coordinator to get the contact
  information for the trial site.
• 4) Over the following weeks and months,
  TrialMatch Coordinators follow up with
  constituents to assist with any challenges or
  questions that come up and to track outcomes.

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TrialMatch What does it contain?

• Types of Trials

• Questionnaire types

• Alzheimers, Related Dementia, and Mild Cognitive
  Impairment (MCI) trials
• Pharmacological (Drug) and Non-Pharmacological
  (Non-Drug) Studies
• U. S. and Canadian Trials

• Person with dementia
• Caregiver
• Healthy Volunteer

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What types of trials are available?

• Treatment Trials
• Diagnostic Studies
• Prevention Trials
• Screening Studies
• Quality of Life Studies

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Where do the listings come from?

• Clinicaltrials.gov
• Directly from Researchers

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Who Can Benefit from Using TrialMatch?

• Persons living with the Alzheimers Disease,
  Related dementias, Mild Cognitive Impairment
• Caregivers
• Healthy Volunteers
• Physicians Researchers

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TrialMatch Service Benefits
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• Alzheimers Association TrialMatch is funded
  solely by the Alzheimers Association and
  includes all applicable studies without
  preference to any study sponsor.
• No recruitment fees or other compensation is
  collected for clinical trial enrollment.

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• Web Address alz.org/trialmatch
• Phone [phone]

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