1. CONNECTING THE AGING NETWORK, INDIVIDUALS WITH DEMENTIA, AND CAREGIVERS WITH RESEARCH OPPORTUNITIES July 12, 2012

2. 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@aoa.hhs.gov 2

3. http://www.aoa.gov/AoA Root/AoA_Programs/HP W/Alz_Grants/index.asp x#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

4. States with DS grants are marked with * Total Active ADSSP Grants

5. http://www.aoa.gov/AoA Root/AoA_Programs/HP W/Alz_Grants/index.asp x#currenthttp://www.aoa.gov/AoA Root/AoA_Programs/HP W/Alz_Grants/index.asp x#current – 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.

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

7. 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 http://grants.nih.gov/grants/guide/pa- files/PA-11-123.html

8. 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 (301) 496-9350 SilverbergN@mail.nih.gov 8

9. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging www.nia.nih.gov http://www.nia.nih.gov/alzheimers/ alzheimers-disease-research-centers NIA-funded Alzheimer’s Disease 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

10. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging 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

11. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging www.nia.nih.gov http://www.adcs.org Alzheimer's Disease Cooperative 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

12. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging www.nia.nih.gov Salt Lake City More than 70 sites across the US and Canada Overlaps with ADCs

13. 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

14. 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.

15. 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 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.

16. 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?

17. 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

18. 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.

19. 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?

20. –Alleviating Fear –Providing Hope –Clearing a Path –Giving Direction Why We Need to Do Research in AD?

21. 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

22. 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

23. 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)

24. 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

25. What is Clinical Research? A few examples of ongoing studies: 1. Risk Factors: Genetics Initiative 2. Diagnostics: Alzheimer’s Disease Neuroimaging Initiative 2 (ADNI-2) 3. Treatment: Resveratrol

26. 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

27. 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.

28. 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.

29. Who Needs to Be Involved in Clinical Research for AD? Diverse Communities Persons & Families Health Care Providers Researchers Aging Network Research Sponsors

30. 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

31. 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.

32. 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

33. 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

34. 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

35. 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

36. How to Actively Connect? See and hear next presentations, –http://www.alz.org (TrialMatch)http://www.alz.org –http://www.nia.nih.gov/alzheimers (ADEAR),http://www.nia.nih.gov/alzheimers 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.adcs.org –http://www.clinicaltrials.govhttp://www.clinicaltrials.gov

37. Contact Information Diana R. Kerwin, MD Cognitive Neurology and Alzheimer's Disease Center Northwestern University 645 N Michigan Avenue, Suite 630 Chicago, IL 60611 E-mail: d-kerwin@northwestern.edud-kerwin@northwestern.edu Clinical office: 312-695-9627

38. Contact Information Raj Shah, MD Rush Alzheimer’s Disease Center Rush University Medical Center 600 South Paulina, Suite 1022 Chicago, IL 60612 E-mail: Raj_C_Shah@rush.edu

39. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging 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

40. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging www.nia.nih.gov http://www.nia.nih.gov/alzheimers /topics/research Free Fact Sheet

41. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging www.nia.nih.gov http://www.nia.nih.gov/alzheimers/ clinical-trials 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

42. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging 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

43. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging 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

44. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging 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

45. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging 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

46. Alzheimer’s Disease Education and Referral (ADEAR) Center National Institute on Aging www.nia.nih.gov Questions? Contact ADEAR Call toll-free: 1-800-438-4380 Mon-Fri, 8:30 am-5:00 pm Eastern Time or email: adear@nia.nih.gov adear@nia.nih.gov

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49. 49 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

50. 50 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.

51. 51 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.***

52. 52 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

53. 53 What types of trials are available? Treatment Trials Diagnostic Studies Prevention Trials Screening Studies Quality of Life Studies

54. 54 Where do the listings come from? Clinicaltrials.gov Directly from Researchers

55. 55 Who Can Benefit from Using TrialMatch? Persons living with the Alzheimer’s Disease, Related dementias, Mild Cognitive Impairment Caregivers Healthy Volunteers Physicians & Researchers

56. 56 TrialMatch Service Benefits

57. 57 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.

58. 58 Web Address: alz.org/trialmatch Phone: 1.800.272.3900

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