National Alzheimer s & Dementia Patient & Caregiver-powered Research Network (ADPCPRN)- Alzheimer s PPRN

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1 National Alzheimer s & Dementia Patient & Caregiver-powered Research Network (ADPCPRN)- Alzheimer s PPRN Ronald Petersen M.D. PhD. Principal Investigator Alzheimer s PPRN Professor of Neurology, Mayo Clinic Collegeof Medicine Director, Mayo Clinic Study of Aging Mayo Clinic Alzheimer s Disease Research Center 1

2 Alzheimer s PPRN ( Collaboration between Mayo Clinic, the University of Florida, and UsAgainstAlzheimer s (UsA2) Networks and Brain Health Registry ( UCSF) PI: Dr. Ron Petersen, Director of the Mayo Clinic Study of Aging (MCSA) and the Mayo Clinic Alzheimer s Disease Research Center (ADRC) Co-PI: Dr. Glenn Smith, Chair and Elizabeth Faulk Endowed Professor, Department of Clinical & Health Psychology, University of Florida Co-PI: Meryl Comer, President, Geoffrey Beene Foundation Alzheimer s Initiative, and UsA2 Board Member Co-PI and Program Director: Alex Alexander, Mayo Clinic Stakeholders include patients, caregivers, leaders of patient groups, directors of existing patient registries, CDRN/PPRN/CTSA collaborators, and clinical studies representatives.

3 Alzheimer s PPRN Aims Amplifying the Patient and Caregiver voice to accelerate development of effective treatments for Alzheimer s disease (AD) and related dementias. Alzheimer s PPRN Aims: enroll an increasingly large number of subjects into this patient-centered network with a minority recruitment focus, obtain self-reported information and measures of cognition at baseline and longitudinally, screen & refer subjects for clinical trials, and test a computable patient phenotype 3

4 National AD PCPRN Attributes Virtual Prevention, Observational and Intervention Patient-focused studies Validation of Caregiver as principal and surrogate for patient-reported outcomes Focus on Minority Populations African American and Latinos Caregiver Impact mobile Patients and Caregivers Developing, conducting, and disseminating patient-focused research

5 Research Goals The primary research objective ADPCPRN is to enhance enrollment in clinical trials, particularly in dementia, cognitive impairment and Alzheimer s disease The Brain Health Registry is set up primarily to do that Other research goals Participate in PCORnet studies by providing a cognitive profile Seek subjects with the diagnosis of MCI in other PPRN s Participate in mindfulness study Establish one-on-one collaborations with other PPRN s Develop computable phenotypes for AD AD PCPRN can provide a cognitive phenotype to any PCORnet partner A major emphasis of our PPRN is the focus on the participant and the caregiver 5

6 Participant and Caregiver Engagement Participants/Caregivers: Governance and Advisory Council Members Being part of Governance As Co- Investigators involved in decision making and not just advisory roles More effective feedback loop from/to participants/caregivers Managing expectations Diverse representation in the decision making process Caregivers engaged as in-place co-investigators/mobile technologies tools for engagement, tracking, tabbing AD PSA/Social media outreach through high profile P/C couples: B. Smith & Dan Gatsby, Kim & Glen Campbell, Greg & Mary O Brien, Leeza Gibbons 6

7 Governance and Advisory Roles Diversity Council African American and Latino (Institutional and Non-profit networks) Caregiver online Facebook moderators & Bloggers: Multiplier effect Governance Council Meets Monthly Advisory Council meets bi-annually: Individual Councils twice quarterly through conference calls. Patients and Caregivers Diversity Technical Registries and Clinical Trials Communication and Outreach 7

8 Collaborations CDRNs Cohort creation and channel to potential trials PPRNs: Studies that would be enhanced by cognitive data sets CTSAs Broader PCORnet : Sharing of AD PCPRN mobile cognitive tracking tools Brain Health registry access for other disease PPRNs Novel data sets on real-time/longitudinal cognitive changes through collaboration with PPRNs working on co-morbid conditions. Others 8

9 National Alzheimer s & Dementia Patient & Caregiver-powered Research Network (ADPCPRN)- Alzheimer s PPRN Michael W. Weiner, MD Rachel L. Nosheny, Ph.D. University of California, San Francisco 9

10 A UCSF-based, internet based registry to facilitate clinical neuroscience research Brain Health Registry (BHR) is the main AD-PCPRN mechanism for participant and study partner/caregiver Recruitment Longitudinal data capture Referral to studies Currently over 29,000 AD-PCPRN participants in BHR Age 50+ Have consented online Agree to be contacted about future studies Includes participants with a range of cognitive function, from normal to dementia

11 BrainHealthRegistry.org 11

12 How it works UCSF IRB approved; Obtain online consent from all participants Sign up Self-reported cognitive function, demographics, health, medications, lifestyle. Focus on eligibility criteria for AD trials. Online Cognitive tests Ø Cogstate, Ltd. Ø Lumos Labs, Inc. Ø Memtrax, llc. Participants return and repeat tasks every 6 months; can identify those undergoing cognitive decline Tell us about yourself Take some tests Come back Come back again 12

13 PCORI Eligibility Dashboard Location Geographic Distribution >1200 of participants By County >

14 Demographics N=29,356 Gender Unknown Male Female 26% 73% 14

15 Demographics Race 4.7% African American 2.2% Asian 85.7% Caucasian 1.2% Declined To State 2.8% Mixed 0.3% Native American 2.4% Other 0.1% Pacific Islander 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000 20,000 22,000 24,000 ender Education 2.8% Grammar School 5.8% High School 18% Some College 8.5% 2 Year Degree 29.1% 4 Year Degree 24.7% Masters Degree 4.9% Doctoral Degree 5.8% Professional Degree Ethnicity Unknown Latino Not Latino 96% 3% 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 15

16 Alzheimer s risk factors Family History of Alzheimer's Unknown Yes No 2% Memory Concern Unknown Yes No 2% 64% 33% 45% 52% 16

17 Eligibility of BHR participants for a hypothetical Alzheimer s clinical trial Based on Self report of diagnosis Self report of memory complaint Cog. test scores Self-report medical history Prescreened Ineligible n=21, %$ 1.1%$ 4.4%$ Self-reported dementia n= %$ Possible cognitive Impairment n=1278 No evidence of cognitive impairment n=

18 Retention and task completion rates 35,000 30,000 29,356 # of Participants 25,000 20,000 15,000 10,000 5, ,914 23,628 5,585 16,991 3,185 Returned for follow-up Completed all study tasks 7,381 1,741 5,078 Baseline 6-month 12-month 18-month 24-month

19 Retention and task completion rates # of Participants 35,000 30,000 25,000 20,000 15,000 10,000 5, ,356 9,914 23,628 42% return at 6-months 32% return at 12-months 36% return at 18-months 27% return at 24-months 5,585 16,991 3,185 Returned for follow-up Completed all study tasks 7,381 1,741 5,078 Baseline 6-month 12-month 18-month 24-month

20 Patient-centered features of the Brain Health Registry AD-PCPRN participants enrolled in BHR. Choose their level of participation and the amount of data they share Give us feedback about their BHR experience Can download their questionnaire data Are informed about results and impact through newsletters and news on the BHR website Opt-in to additional studies on a case-by-case basis Control where their data goes; BHR only shares deidentified data 20

21 Patient-centered features: Planned for Coming in , participants will Have access to aggregate data through online visualization tools Get feedback about their questionnaire data, including actionable information Get feedback about cognitive test results Have increased access to resources such as educational materials Be able to invite a study partner to join 21

22 BHR Caregiver and Study Partner Portal Infrastructure within the BHR through which a study partner, self-identified or identified by a participant, can separately register, consent, login, and give info. about a participant AND the study partner him/herself BHR can link participant and study partner data Login/Consent Questions about participant Questions about study partner him/herself Cognitive function/chan ges Activities of Daily Living function/ch anges Neuropsychiatric symptoms Demographics Short health screener relationship to participant, with caregiving gateway question Caregiver Module 22

23 BHR Caregiver and Study Partner Portal Goals: To obtain accurate, detailed info. about participants cognitive status and daily functioning through study partner report To advance our understanding of the effects of caregiving on the caregiver Impact Improve screening for clinical trials Improve screening for cognitive problems in healthcare settings Improve caregiver health Increase BHR enrollment, especially of impaired participants Broad applications in other populations and diseases 23

24 We are currently referring participants to Alzheimer s clinical studies/study sites N=29,356 BHR queries database for eligible participants n=4752 Identified as eligible; receive with study details n=1131 Indicate interest in study n=750 Contact site n=339 Enroll in study 16% of total cohort 24% of referred 66% of interested 45% of those who contact site 24

25 Current Partnerships 25

26 National Alzheimer s & Dementia Patient & Caregiver-Powered Research Network (AD-PCPRN)-Alzheimer s PPRN Meryl Comer President & CEO, Geoffrey Beene Foundation Alzheimer s Initiative; Co-PI, AD-PCPRN 26

27 National AD-PCPRN Amplifying the Patient and Caregiver voice to accelerate development of effective treatments for Alzheimer s disease (AD) and related dementias. Alzheimer s PPRN Aims: 1) enroll an increasingly large number of subjects into this patient-centered network with a minority recruitment focus, 2) obtain self-reported information and measures of cognition at baseline and longitudinally, 3) screen & refer subjects for clinical trials, and 4) test a computable patient phenotype

28 National AD-PCPRN Attributes

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30 AD-PCPRN Governance/Advisory Council Structure Governance Council Caregivers/Patient Advisory Communications and Outreach Advisory Technical Advisors Registries/Clinical Trials Advisory Diversity Advisory 30

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32 Caregiver and Study Partner Portal Login/Con sent Questions about participant Questions about study partner him/herself Cognitive function/c hanges Activities of Daily Living function/chang es Neuropsychiatric symptoms Demographics Short health screener relationship to participant, with caregiving gateway question Caregiver Module 32

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34 Is a clinical trial right for me? decision tool built on the Roobrik platform questions covering: status & situation cognitive concerns trial fitness dispositional trial fitness - logistical Roobrik for Clinical Trial Recruitment helping families with early concerns understand that they have clinical research options Comprehensive results dashboard connection to trial search cognitive concern score trial fitness score personalized next steps and connections to info and services first person summary report

35 Registries & Clinical Trials Crowds & Cures List 1000 We Give Voice to Your Story roobrik TrialReach Patient- Focused Drug Development AD-PCPRN 40 Partner Orgs Activists, African Americans, Clergy, Latinos, Researchers, Women, Facebook Caregiver Community

36 Wrap Up and Ongoing Discussion. Ronald Petersen M.D. PhD. 36

37 Alzheimer s PPRN in the news Capitol Hill Briefing on June riefing%2fbog+mtg%2ftwitter+chat&utm_medium= Best Practice Sharing Session by PCORI- June 28 PCORI Blog 37

38 Contacts Dr. Ronald Petersen : peter8@mayo.edu Dr. Michael Weiner : michael.weiner@ucsf.edu Dr. Rachel Nosheny : rachel.nosheny@ucsf.edu Meryl Comer : mjmcomer@gmail.com Presenters:- Contacts:- Alzheimer s PCPRN : alexander.alex@mayo.edu USAgainstAlzheimers : ssachar@usagainstalzheimers.org BHR :rachel.nosheny@ucsf.edu 38

39 Useful Links Useful links: