CONNECTING THE AGING NETWORK, INDIVIDUALS WITH DEMENTIA, AND CAREGIVERS WITH RESEARCH OPPORTUNITIES...

CONNECTING THE AGING NETWORK, INDIVIDUALS WITH DEMENTIA, AND

CAREGIVERS WITH

RESEARCH OPPORTUNITIES

July 12, 2012

WELCOME

Michelle Washko, PhD

Center for Disability and Aging Policy Administration for Community Living

U.S. Department of Health & Human Services

202-357-3447

[email protected]

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http://www.aoa.gov/AoARoot/

AoA_Programs/HPW/Alz_Grants/

index.aspx#current

Alzheimer’s Disease

Supportive Services

Program• Delivers supportive

services• Translates evidence-

based models• Advances state initiatives

toward coordinated systems of home and community-based care

States with DS grants are marked with *

MT

ID

WA

CO

NV

CA

AZ

MN

TX

WI

IL

KY

TN

INOH

MI

ALMS

GA

FL

SC

WV VA

NC

PA

MD

NJ

RI SD

MO

OK

NY*1

HI

AK

NHMA 1

CT 1

ND

NJ 1

UT

KSMO

VA

OKSC

AL

NV

ID

IN

VT ME

OR

NM AR

ID

WA 1

CO 1

WY

NV

CA 2

AZ 2

MN*4

TX 1

IA

WI 3

KY 1

TN 2

IN OH*4

MI 3

AL

LAGA*6

FL 3

SC

VA

NC 3

MO

OK

NE

AK

DC 1

ND

UT 2

KS

MO 1

VA 1

OK SC 1

AL

NV 1

ID 1

IN

1 grant

VT 1 ME 3

OR 1

NM 1

PR 1

2 grants

3 grants

4+ grants

DE

Total Active ADSSP Grants

http://www.aoa.gov/AoARoot/

AoA_Programs/HPW/Alz_Grants/

index.aspx#current – scroll down to see Current Projects

Evidence-BasedCooperativeAgreements: 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.

ADSSP Grantee Profiles

http://www.adrc-tae.org/tiki-index.php?page=adsspmap

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

WELCOME

Nina Silverberg, PhD

Assistant Director

Alzheimer's Disease Centers ProgramDivision of Neuroscience

National Institute on Aging

National Institutes of Health

U.S. Department of Health & Human Services

(301) 496-9350

[email protected]

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Alzheimer’s Disease Education and Referral (ADEAR) CenterNational Institute on Aging

www.nia.nih.gov

http://www.nia.nih.gov/alzheimers/alzheimers-disease-research-centers

NIA-funded Alzheimer’sDisease Centers:• ADCs conduct research

on all aspects of Alzheimer’s Disease

• Provide diagnosis and education services for patients and families

• Opportunities to participate in research


www.nia.nih.gov

• 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


www.nia.nih.gov

http://www.adcs.org Alzheimer's DiseaseCooperative Study (ADCS)• NIA-funded collaboration to

facilitate the discovery, development and testing of new Alzheimer’s treatments

• Conducts large, multi-site trials

• Focus on drugs that might not be developed by industry


www.nia.nih.gov

Salt Lake City

More than 70

sites across the

US and Canada

Overlaps with ADCs

Connecting the Aging Network to Clinical Researchers at National Institute on Aging’s Alzheimer’s Disease Centers

Raj C. Shah, MD

Associate Professor

Rush Alzheimer’s Disease Center

Rush University

Diana R. Kerwin, MD

Assistant Professor

Cognitive Neurology and Alzheimer’s Disease Center

Northwestern University

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 Alzheimer’s Disease Assistance Center Grant.

Disclosures – Raj C. Shah, MDI 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 Alzheimer’s 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 Alzheimer’s 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.

Discussion Points

• Where are the gaps in diagnosing, treating, and preventing Alzheimer’s disease?

• Why we need to do clinical research in Alzheimer’s disease?

• What is clinical research?

• Who needs to be involved in clinical research?

• How can we work together to support clinical research?

The Problem of Alzheimer’s 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

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.

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?

–Alleviating Fear

–Providing Hope

–Clearing a Path

–Giving Direction

Why We Need to Do Research in AD?

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

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

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)

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

What is Clinical Research?

A few examples of ongoing studies:

1. Risk Factors: Genetics Initiative2. Diagnostics: Alzheimer’s Disease

Neuroimaging Initiative 2 (ADNI-2)3. Treatment: Resveratrol

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

ADNI-2

• Purpose of trial: To determine body fluid, genetic, and imaging biomarkers that may predict who is likely to develop Alzheimer’s 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.

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 Alzheimer’s.

• 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.

Who Needs to Be Involved in Clinical Research for AD?

Diverse Communities Persons & Families

Health Care Providers Researchers

Aging Network

Research Sponsors

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

Case Example:ASPirin 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.

Case Example:ASPirin 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


Research Centers: Available to give presentations to Aging Network staff

about what research is about.Available to give community presentations requested by

Aging NetworkAvailable for questions about research for potential

participantsMake it easy to access research options


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


Research Centers and Aging Network: Sharing best practices on what works and what does

not workFiguring out efficient ways for link caregivers, persons at

risk for AD, and persons with AD to each group

How to Actively Connect?

• See and hear next presentations,– http://www.alz.org (TrialMatch)– http://www.nia.nih.gov/alzheimers (ADEAR),

Other options– Alzheimer’s Disease Information Network (AD-IN) by the

NIA Alzheimer’s Disease Cooperative Study’s national Information Network at http://www.adcs.org

– http://www.clinicaltrials.gov

Contact Information

• Diana R. Kerwin, MDCognitive Neurology and Alzheimer's Disease Center

Northwestern University645 N Michigan Avenue, Suite 630Chicago, IL 60611E-mail: [email protected]

Clinical office: 312-695-9627

Contact Information

• Raj Shah, MDRush Alzheimer’s Disease Center

Rush University Medical Center600 South Paulina, Suite 1022Chicago, IL 60612E-mail: [email protected]


www.nia.nih.gov

http://www.nia.nih.gov/alzheimers NIA’s ADEAR Center Website

features:• AD Research Centers

• Clinical Trials

• Alzheimer’s research news• Alzheimer’s topics:

Symptoms, Diagnosis, Treatment, Research, more

• E-alert Sign-up

• Free publications


www.nia.nih.gov

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

Free Fact Sheet


www.nia.nih.gov

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

NIA ADEAR Search for Alzheimer’s Clinical Trials

Find trials by:• Location• Eligibility criteria• Drugs tested

• Featured trials• ADEAR phone support

1-800-438-4380• Sign up to receive e-alerts, RSS

when new trials posted/updated


www.nia.nih.gov

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


www.nia.nih.gov

http://www.clinicaltrials.gov

• Screen shot

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

databases• Searchable


www.nia.nih.gov

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


www.nia.nih.gov

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


www.nia.nih.gov

Questions? Contact ADEARCall toll-free:

1-800-438-4380Mon-Fri, 8:30 am-5:00 pm Eastern Time

or email:[email protected]

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TrialMatch® Objectives

• Move science forward towards a world without Alzheimer’s

• Increase the numbers of individuals enrolled in Alzheimer’s trials and studies

• Provide information to the public and healthcare professionals to help facilitate Alzheimer’s 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:

• Alzheimer’s, Related Dementia, and Mild Cognitive Impairment (MCI) trials

• Pharmacological (Drug) and Non-Pharmacological (Non-Drug) Studies

• U. S. and Canadian Trials

Questionnaire types:

• 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 Alzheimer’s Disease, Related dementias, Mild Cognitive Impairment

• Caregivers

• Healthy Volunteers

• Physicians & Researchers

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TrialMatch Service Benefits

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• Alzheimer’s Association TrialMatch™ is funded solely by the Alzheimer’s 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: 1.800.272.3900

CONNECTING THE AGING NETWORK, INDIVIDUALS WITH DEMENTIA, AND CAREGIVERS WITH RESEARCH OPPORTUNITIES...

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