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Research Advocacy Training Research Advocacy Training Fairmont Dallas Hotel 1717 N. Akard Street Dallas, TX 75201 November 19, 2019 Akin Gump Strauss Hauer & Feld LLP 2300 N. Field Street, Suite 1800 Dallas, TX 75201 November 20-21, 2019 This training is funded through the Eugene Washington PCORI Engagement Award Program, Award 3445-AAR. Catalyzing Innovation for Healthy Aging November 19, 2019 Dear Talk NERDY to Me Network Advocates, Advisors, and Guests, Welcome and thank you for joining us! We are very excited and grateful to have you here for the training of the Talk N.E.R.D.Y. to Me Network. As you know, the purpose of this program is to develop an older adult patient and family caregiver-led nationwide group of advocates with the following: • Basic understanding of patient-centered outcomes research (PCOR) • Ability to develop research questions that are important to older adult patients and their family caregivers and will ultimately help inform research design, encourage broader participation, and produce meaningful health outcomes • Willingness to provide the patient and family caregiver perspective by participating in PCOR opportunities at the national or local level. You each bring a unique perspective to this training, and that has already helped us to think about this curriculum in ways we would not have considered otherwise. Some of you have advanced degrees and many years of professional experience. Some of you have less formal education, but extensive personal experience living with a chronic condition or caring for someone who has that condition. Some of you may have variations of one or both. To set a level from the beginning, let me say this: everyone’s experience is valid and important to this process. My request is for all of us to approach this training with an openness and willingness to both teach and learn from each other. If someone you are training with is struggling to understand something, be patient and help them along. If you have a question, be willing to ask—chances are, you are not the only one who has that question. Please use this opportunity to learn, teach, and connect with each other. The psychologist, Dr. Joanne Cacciatore, states it well: “There is no pharmacy that can fill the need for compassionate interaction with others. There is no panacea. The answer to human suffering is both within us and between us.” Best, Sue Peschin TALK NERDY TO ME NETWORK ADVOCACY TRAINING NURTURING ENGAGEMENT IN RESEARCH AND DEVELOPMENT WITH YOU NOVEMBER 19-21, 2019 TABLE OF CONTENTS AGENDA ......................................................................................... TAB 1 SESSION MATERIALS ........................................................................ TAB 2 ARTICLES .............................................................................. TAB 3 ALZHEIMER’S DISEASE ........................................................ TAB 4 ATRIAL FIBRILLATION .......................................................... TAB 5 HEART VALVE DISEASE ....................................................... TAB 6 MACULAR DEGENERATION ................................................... TAB 7 PAIN MANAGEMENT............................................................. TAB 8 ACTIVITY SHEETS AND EVALUATION FORMS ............................... TAB 9 BIOGRAPHIES OF ATTENDEES .......................................................... TAB 10 WEBINARS .................................................................................... TAB 11 GLOSSARY OF TERMS .................................................................... TAB 12 MEDIA CONSENT FORM .................................................................. TAB 13 TRAVEL REIMBURSEMENT POLICY AND EXPENSE FORMS .................... TAB 14 Talk NERDY to Me Network Advocacy Training Nurturing Engagement in Research and Development with You (NERDY) November 19-21, 2019 AGENDA Tuesday, November 19 Location: Fairmont Dallas Hotel (1717 North Akard Street, Dallas, TX 75201) 6:00 pm Registration and Dinner 6:30 pm Welcome and Introductions: Susan Peschin, MHS(Alliance for Aging Research (AAR)) 7:15 pm Guest Speakers: Lia Hotchkiss, MPH (Patient- Centered Outcomes Research Institute) and Mellanie True Hills, CSP (StopAfib.org) 8:00 pm Wrap-up Wednesday, November 20 Location: Akin Gump Strauss Hauer & Feld, LLP (2300 North Field Street, Suite 1800, Dallas, TX 75201) 8:00 am Breakfast 8:30 am Program begins 8:40 am Session One: Clinical Trials George Perry, PhD (University of Texas at San Antonio), Maria Langas, PharmD (Janssen Pharmaceuticals), Srini Potluri, MD (The Heart Hospital, Baylor), Carolyn Carman, OD, FAAO, and Patrick Dougherty, PhD (The University of 1 Texas MD Anderson Cancer Center and The University of Texas Health Science Center) Participants will learn about clinical trial design from researchers in the field. 10:00 am Break 10:15 am Session One, Continued Participants will practice extracting key information from a scientific journal article. 11:30 am Break and then Lunch 12:15 pm Lunch 1:15 pm Session One, Continued Participants will explore current research. 2:40 pm Session Two: Patient-Centered Outcomes Research Susan Peschin, MHS (AAR) and Sara Collina, JD (Blueberry Hill Strategies) Participants will evaluate research and identify ways to make it more patient-centered. 4:00 pm Wrap-up Dinner on your own; we encourage you to join your colleagues and will provide restaurant recommendations. Thursday, November 21 Location: Akin Gump Strauss Hauer & Feld, LLP (2300 North Field Street, Suite 1800, Dallas, TX 75201) 8:30 am Breakfast 9:00 am Session Three: Advocate to Advocate and Action Plans Penney Cowan (American Chronic Pain Association), Susan Strong (Heart Valve Voice, US), and Jeff Todd (Prevent Blindness) 2 Participants will engage with experienced research advocates to better understand how to find and create advocacy opportunities, then work on personalized action plans. 11:30 am Participants will share their action plans with the larger group. 12:30 pm Wrap-up Boxed lunches available to go. 3 Journal of Alzheimer’s Disease 44 (2015) 549–560 549 DOI 10.3233/JAD-141626 IOS Press A Clinical Study of Lupron Depot in the Treatment of Women with Alzheimer’s Disease: Preservation of Cognitive Function in Patients Taking an Acetylcholinesterase Inhibitor and Treated with High Dose Lupron Over 48 Weeks Richard L. Bowena,∗, George Perryb,c, Chengjie Xiongd, Mark A. Smithc,† and Craig S. Atwoode,f,g,∗ aOTB Research, Charleston, SC, USA bUTSA Neurosciences Institute and Department of Biology, University of Texas at San Antonio, San Antonio, TX, USA cDepartment of Pathology, School of Medicine, Case Western Reserve University, Cleveland, OH, USA dDepartment of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA eDepartment of Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA f Geriatric Research, Education and Clinical Center, Veterans Administration Hospital, Madison, WI, USA gSchool of Exercise, Biomedical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia Handling Editor: Massimo Tabaton Accepted 8 September 2014 Abstract. To test the efficacy and safety of leuprolide acetate (Lupron Depot®) in the treatment of Alzheimer’s disease (AD), we conducted a 48-week, double-blind, placebo-controlled, dose-ranging study in women aged 65 years or older with mild to moderate AD. A total of 109 women with mild to moderate AD and a Mini-Mental State Examination score between 12 and 24 inclusive were randomized to low dose Lupron Depot® (11.25 mg leuprolide acetate), high dose Lupron Depot® (22.5 mg leuprolide acetate), or placebo injections every 12 weeks. There were no statistically significant differences in primary efficacy parameters (ADAS-Cog and ADCS-CGIC), although there was a non-statistically significant trend in favor of the high dose Lupron group on the ADAS-Cog. There were no statistically significant differences in secondary efficacy parameters (NPI, ADCS-ADL, BI, and ADCS-Severity Rating). However, in the a priori designated subgroup analysis of patients taking an †Deceased. ∗Correspondence to: Richard L. Bowen, MD, OTB Research, 217 School of Medicine and Public Health, William S. Middleton Memo- Calhoun St, Unit 1, Charleston, SC 29401, USA. Tel.: +1 843 480 rial VA(GRECC 11 G), 2500 Overlook Terrace, Madison, WI 53705, 2273; Fax: +1 843 501 7698; E-mail: [email protected]. USA. Tel.: +1 608 256 1901/Ext. 11664; Fax: +1 608 280 7291; and Craig S. Atwood, PhD, University of Wisconsin-Madison E-mail: [email protected]. ISSN 1387-2877/15/$27.50 © 2015 – IOS Press and the authors. All rights reserved 550 R.L. Bowen et al. / Lupron for the Treatment of Alzheimer’s Disease acetylcholinesterase inhibitor (AChEI), there was a statistically significant benefit in the high dose group compared to both the low dose and placebo groups as determined by ADAS-Cog (mean decline: 0.18, 4.21, and 3.30), ADCS-CGIC (% subjects experiencing decline: 38, 82, and 63), and ADCS-ADL (mean decline: −0.54, −8.00, and −6.85), respectively. No differences between treatment groups were seen on the NPI, ADCS-CGI Severity Rating, or the BI in the subgroup analysis. These data indicate that cognitive function is preserved in patients treated with high dose Lupron who were already using AChEIs. The positive interaction between Lupron and AChEIs warrants further investigation for the treatment of AD. Keywords: 17␤-estradiol, acetylcholinesterase inhibitor, Alzheimer’s disease, apolipoprotein
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