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 College of Medicine
Director, Mayo Clinic Study of Aging Mayo Clinic Alzheimer’s Disease Research Center
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Alzheimer’s PPRN ( www.alzheimerspcprn.org )
Collaborationbetween MayoClinic,theUniversityofFlorida,and
UsAgainstAlzheimer’s(UsA2)Networksand BrainHealth Registry(UCSF)
§ PI: Dr. Ron Petersen, Director of the Mayo Clinic Study of Aging (MCSA) and
theMayo ClinicAlzheimer’sDiseaseResearch Center(ADRC)
§ Co-PI: Dr. Glenn Smith,Chairand Elizabeth FaulkEndowed Professor,
Department of Clinical & Health Psychology, University of Florida
§ Co-PI: Meryl Comer,President,GeoffreyBeeneFoundation Alzheimer’s
Initiative, and UsA2 Board Member
§ Co-PI and ProgramDirector:AlexAlexander,MayoClinic
Stakeholders include patients, caregivers, leaders of patient groups, directors of
existingpatientregistries,CDRN/PPRN/CTSA collaborators,and clinical studies
representatives.
Alzheimer’s PPRN Aims
AmplifyingthePatientand Caregiver voiceto acceleratedevelopmentof
effective treatments for Alzheimer’s disease (AD) and related dementias.
§ Alzheimer’s PPRN Aims:
enroll an increasinglylargenumberofsubjectsinto thispatient-centered
networkwith a minorityrecruitmentfocus,
obtain self-reported information and measuresofcognitionatbaseline
and longitudinally,
screen & refersubjectsforclinical trials,and
testa computablepatientphenotype
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National AD PCPRN Attributes
Prevention,
Patient-focused studies
Observational
Validation of Caregiver as
Virtual
and
principal and surrogate for
Intervention
patient-reported outcomes
African
American
Caregiver
Focus on Minority Populations
and
Impact
Latinos
Patients
Developing, conducting, and
and
disseminating patient-focused
mobile
research
Caregivers
Research Goals
Theprimaryresearch objectiveADPCPRNisto enhanceenrollmentin clinicaltrials,
particularlyin dementia,cognitiveimpairmentand Alzheimer’sdisease
§ TheBrain Health Registry issetup primarilyto 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
§ Establishone-on-onecollaborationswith otherPPRN’s
§ Develop computable phenotypes for AD
AD PCPRN can providea cognitivephenotypeto anyPCORnetpartner
A majoremphasisofourPPRN is the focuson the participantandthecaregiver
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Participant and Caregiver Engagement
Participants/Caregivers: Governance and Advisory Council Members
Beingpartof Governance-
§ As Co-Investigatorsinvolved in decision makingand notjustadvisoryroles
§ More effective feedback loop from/to participants/caregivers
§ Managing expectations
§ Diverse representation in the decision making process
Caregiversengaged as“in-place”co-investigators/Mobiletechnologies-toolsfor
engagement,tracking,tabbingAD
PSA/Social media outreach through high profile P/C couples:
§ B. Smith & Dan Gatsby,Kim& Glen Campbell,Greg& MaryO’Brien,Leeza
Gibbons
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Governance and Advisory Roles
Diversity Council - African American and Latino (Institutional and Non-profit networks)
CaregiveronlineFacebookmoderators&Bloggers:Multipliereffect
GovernanceCouncil MeetsMonthly
AdvisoryCouncil meetsbi-annually: Individual Councilstwicequarterlythrough
conference calls.
§ Patients and Caregivers
§ Diversity
§ Technical
§ Registriesand ClinicalTrials
§ Communicationand Outreach
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Collaborations
CDRNs
§ Cohortcreation and channel to potentialtrials
PPRNs: Studies that would be enhanced by cognitive data sets
CTSAs
BroaderPCORnet:
§ Sharing of AD PCPRN mobile cognitive tracking tools
§ Brain Health registryaccessforotherdiseasePPRNs
§ Novel data setson “real-time/longitudinalcognitivechangesthrough
collaboration with PPRNs working on co-morbid conditions.
Others
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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
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A UCSF-based, internet based registry to facilitate clinical neuroscience
research
BrainHealth Registry (BHR) is the main AD-PCPRN mechanismfor
participantand study partner/caregiver
§ Recruitment
§ Longitudinal data capture
§ Referralto studies
Currentlyover 29,000 AD-PCPRN participantsin BHR
§ Age 50+
§ Have consentedonline
§ Agree to be contacted aboutfuturestudies
§ Includesparticipantswith a rangeof cognitive function,fromnormalto
dementia
BrainHealthRegistry.org
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How it works
UCSF IRB approved;
Sign up
Obtain online consent from all
participants
Self-reported cognitive function,
Tell us about yourself
demographics, health, medications,
lifestyle. Focus on eligibility criteria
for AD trials.
Online Cognitive tests
Take some tests
Ø Cogstate, Ltd.
Ø Lumos Labs, Inc.
Ø Memtrax, llc.
Come back
Participants return and repeat tasks
every 6 months; can identify those
undergoing cognitive decline
Come back…again
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Geographic Distribution of participants
1-25
26-100
101-400
401-1200
>1200
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Demographics
N=29,356
Gender
Unknown
Male
Female
26%
73%
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Demographics
Ethnicity
Race
Unknown
4.7% African American
Latino
2.2% Asian
Not Latino
3%
85.7% Caucasian
1.2% Declined
To State
2.8% Mixed
0.3% Native American
2.4% Other
0.1% Pacific Islander
96%
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
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
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
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Alzheimer’s risk
factors
Memory Concern
Family History of Alzheimer's
Unknown
Unknown
Yes
Yes
No
No
2%
2%
33%
45%
52%
64%
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Eligibility of BHR participants for a hypothetical
Alzheimer’s clinical trial
Based on
• Self report of diagnosis
Self-reported dementia
• Self report of memory complaint
n=332
• Cog. test scores
• Self-report medical history
1.1%$
Possible cognitive
4.4%$
Impairment
n=1278
Prescreened
Ineligible
19.9%$
n=21,909
No evidence of
cognitive impairment
n=5837
74.6%$
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Retention and task completion rates
35,000
29,356
30,000
23,628
25,000
20,000
Returned for follow-up
16,991
Completed all study
15,000
tasks
9,914
10,000
7,381
5,585
5,078
5,000
3,185
1,741
782
0
Baseline
6-month
12-month
18-month
24-month
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Retention and task completion rates
42% return at 6-months
35,000
32% return at 12-months
29,356
30,000
6% return at 18-months
turn at 24-months
23,
25,000
20,000
ollow-up
l study
15,000
9,914
10,000
5,585
8
5,000
3,185
1,741
782
0
Baseline
6-month
12-month
18-month
24-month
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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 de-
identified data
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Patient-centered features:
Planned for 2016-2107
Coming in 2016-2017, 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
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BHR Caregiver and Study Partner Portal
Infrastructure within the BHR through which
§ a studypartner,self-identifiedoridentified bya participant,can separately
register, consent,login, and give info.abouta participantAND the study
partnerhim/herself
§ BHR can link participantandstudy partnerdata
Login/Consent
Questions about
Questions about
study partner him/herself
participant
Short
Activities of
Demo-
relationship to
Cognitive
Neuro-
health
Daily Living
graphics
participant, with
function/chan
psychiatric
screener
function/ch
symptoms
caregiving “gateway”
ges
anges
question
Caregiver
Module
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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
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We are currently referring participants to
Alzheimer’s clinical studies/study sites
n=4752
N=29,356
n=1131
n=750
n=339
Identified as
BHR queries
eligible;
Indicate
database for
Contact
Enroll in
receive email
interest in
eligible
site
study
with study
study
participants
details
16% of
24% of
45% of
66% of
total
referred
those who
interested
cohort
contact site
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Current Partnerships
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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
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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
networkwith a minority recruitmentfocus,
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
National AD-PCPRN Attributes
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AD-PCPRN Governance/Advisory Council
Structure
Governance
Council
Communications
Registries/Clinical
Caregivers/Patient
Diversity
Technical
and Outreach
Trials
Advisory
Advisory
Advisors
Advisory
Advisory
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Caregiver and Study Partner Portal
Login/Con
sent
Questions about
Questions about participant
study partner him/herself
Cognitive
Short
Activities of
relationship to
function/c
Demographics
health
Daily Living
Neuropsychiatric
participant, with
hanges
screener
function/chang
symptoms
caregiving
es
“gateway”
question
Caregiver
Module
32
https://www.youtube.com/watch?v=ruBhwbz-pno
s a clinical trial right for me?
decision tool built on the Roobrik platform
15-25 questions covering:
tatus & situation
cognitive concerns
rial fitness - dispositional
rial fitness - logistical
Comprehensive results
“dashboard”
Roobrik for Clinical Trial
connection to trial search
cognitive concern score
Recruitment
trial fitness score
helping families with early concerns
personalized next steps and
understand that they have clinical
connections to info and ser vices
research options
first person summary report
R
Wrap Up and Ongoing Discussion ….
Ronald Petersen M.D. PhD.
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Alzheimer’s PPRN in the news…
Capitol Hill Briefing on June 21
§
https://vimeo.com/171818468
§
http://www.pcori.org/events/2016/pcori-and-usagainstalzheimer%E2%80%99s-briefing-
alzheimer%E2%80%99s-disease-research-focus-
caregivers?utm_source=061416+Alz+briefing+and+BOG+meeting&utm_campaign=061416+email%3A+Alz+b
riefing%2FBOG+mtg%2FTwitter+chat&utm_medium=email
Best Practice Sharing Session by PCORI- June 28
§
http://pcornet.org/event/alzheimers-dementia-pprn-opportunities-collaborations-pcornet/
PCORI Blog
§
http://www.pcori.org/blog/alzheimers-network-puts-caregivers-center
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Contacts
Presenters:-
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
Contacts:-
Alzheimer’s PCPRN : alexander.alex@mayo.edu
USAgainstAlzheimers : ssachar@usagainstalzheimers.org
BHR :rachel.Nosheny@ucsf.edu
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Useful Links
Useful links:-
http://www.pcori.org/research-results/2015/national-alzheimers-dementia-
patient-caregiver-powered-research-network
www.alzheimerspcprn.org
http://www.brainhealthregistry.org/
http://www.usagainstalzheimers.org
http://merylcomer.com/
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