Development of Culturally-Sensitive and Patient-Centered Feedback for Alzheimer's Dementia Risk Disclosure
Phase: NA
Conditions: Mild Cognitive Impairment, Healthy Aging
Sponsor: University of Michigan

 
Development of Culturally Sensitive and 
Patient-Centered Feedback for Alzheimer's 
Dementia Risk Disclosure 
 
 
NCT04309500 
 
IRB Approval Date: January 26, 2022 
Uploaded: 09/29/2022 

SHARE(D) Study Protocol 
FULL STUDY TITLE:  
Development of Culturally-Sensitive and Patient-Centered Feedback for 
Alzheimer’s Dementia Risk Disclosure 
SHORT STUDY TITLE: 
The SHARE(D) Project: Sharing Alzheimer’s Risk Estimates with Diverse 
Populations 
Protocol Amendment Number: 01  
 
Original 
 
 
 
 
 
 
Authors: ARF 
Issue Date: 01 May 2019 
 
 
 
 
 
 02 
 
Amendment 
 
 
 
 
 
 
Authors: ARF 
 
 
 
 
 
 
Issue Date: 20 November 2019 
 
 
 
 
 
03 
 
Amendment 
 
 
 
 
 
 
Authors: ARF 
 
 
 
 
 
 
Issue Date: 8 May 2020 
 
 
 
 
 
04 
 
Amendment 
 
 
 
 
 
 
Authors: ARF 
 
 
 
 
 
 
Issue Date: 12 August 2020 
 
 
 
 
 
05  
 
Amendment per IRBMED requested changes 
 
 
 
 
 
 
Authors: ARF 
 
 
 
 
 
 
Issue Date: 02 November 2020 
 
 
 
 
 
06 
 
Amendment 
 
 
 
 
 
 
Authors: ARF 
 
 
 
 
 
 
Issue Date: 10 November 2021 
 
 
 
 
 
07 
 
Amendment 
 
 
 
 
 
 
Authors: ARF 
 
 
 
 
 
 
Issue Date: 3 January 2022 
 
Secondary Registry Numbers: 
 UMIRB: IRBMED HUM00178869 (Stage I) 
 
 UMIRB: IRBMED TBD (Stage II) 
 
 Clinical Trials: NCT04309500 (Stage II) 
 
Sources of Support:   
 
 
NIH/NIA R03 AG063222-01  
 
Contact for Public/Scientific Queries:  
ARF [rahmanam@med.umich.edu] 
 
 
 
 
 
 
 
Trial Sponsor:  
 
NIH/NIA 
 
Address: 
 
 
Neuropsychology Section, Department of Psychiatry 
2101 Commonwealth Blvd., Suite C 
 
 
 
 
Ann Arbor, MI 48105 
 
 
 
 
(734) 936-3180 
 
Public Title:  
 
 
The SHARE(D) Project: Sharing Alzheimer’s Risk Estimates with  
Diverse Populations 
 
Countries of Recruitment: 
United States of America 
 
Problem(s) Studied:  
Dementia – Alzheimer’s Type (DAT) risk disclosure  

 
Intervention: 
Stage I: Observational study (needs assessment); no intervention 
 
 
Stage II: Behavioral Intervention: personalized Dementia-Alzheimer’s type 
 
risk disclosure feedback 
 
Key Inclusion Criteria:  
Stage I: Human volunteers who are consensus diagnosed as cognitively healthy  
or with Mild Cognitive Impairment (MCI) with ability to consent;  65 years of age; 
first-language English; identified co-participant who is cognitively healthy, has 
known the participant for  5 years, and has at least weekly phone/in-person 
contact with the participant 
 
Stage II: Same as Phase I, plus participants must have a negative baseline 
screen for clinically significant depression or anxiety on standardized measures 
and already be followed by a medical provider.  
 
Key Exclusion Criteria: 
Stage I & II: Significant uncorrected sensory impairment, severe neurologic or  
psychiatric diagnosis; consensus diagnosis of dementia 
 
Study Type:   
 
Interventional, single-group design 
 
Primary purpose:  
 
Stage I: Complete assessment of needs, preferences, and rationale regarding  
DAT risk disclosure in participants and their family members of diverse racial-
ethnic backgrounds 
 
Stage II: Develop and pilot personalized DAT risk disclosure protocols with 
participants and family members of diverse racial-ethnic backgrounds; 
investigate initial outcomes including comprehension/recall of results, 
satisfaction, and psychological reactions immediately following risk disclosure 
and at 1- and 6-weeks following risk disclosure 
 
Phase:  
 
 
I/II (Stage II Behavioral Intervention Study) 
 
Date of First Enrollment: 
Stage I: 10/22/19 
 
 
 
 
Stage II: 10/1/20 (anticipated) 
 
Target Sample Size:  
Stage I: up to 120 (60 participant/co-participant dyads) 
 
 
 
 
Stage II: 20 (10 participant/co-participant dyads) 
 
Recruitment Status:  
Stage I: Currently recruiting 
 
 
 
 
Stage II: Currently recruiting 
 
Primary Outcomes: 
 
Stage I:  
(a) Interest in different levels of risk disclosure feedback 
 
 
 
 
 
 
(b) Preferences for different levels of risk disclosure feedback 
(c) Perceived personal threat of DAT 
 
 
 
 
 
 
(d) Perceived benefits of/rationale for risk disclosure 
 
 
 
 
 
 
(e) Perceived barriers to risk disclosure 
 
 
 
 
 
 
(f) Importance of risk disclosure feedback elements 
 
 
 
 
 
Stage II: 
(a) Comprehension/recall of personal risk information 
(b) Psychological distress (mood, anxiety, and event-specific 
distress) 
 
 
 
 
 
 
(c) Satisfaction with feedback process (exploratory) 
 
 
 
 
 
 
 
SECTION 1: Roles & Responsibilities - Contributorship 
 

Annalise Rahman-Filipiak, Ph.D. (ARF) – Principal Investigator 
Affiliations:  
University of Michigan, Department of Psychiatry 
Contact: 
 
rahmanam@med.umich.edu 
Roles & Responsibilities:  
Design conception and initiation 
Preparation of protocol and revisions 
 
 
 
 
Managing correspondence with clinical trials office 
 
 
 
 
Publication of study reports 
 
 
 
 
Preparation of manuscripts 
Recruitment and screening of patients 
 
 
 
 
Data collection  
 
 
 
 
Data entry, verification 
 
 
 
 
Statistical Analyses 
 
 
 
 
Regulatory and compliance management/adverse event reporting 
 
Benjamin Hampstead, Ph.D., ABPP-CN (BMH) – Co-Investigator 
Affiliations:  
VA Ann Arbor Healthcare Systems, Mental Health Service 
University of Michigan, Department of Psychiatry 
Contact: 
 
bhampste@med.umich.edu 
 
Roles & Responsibilities: 
Design conception and initiation 
Mentorship 
 
J. Scott Roberts, Ph.D. (JSR) – Co-Investigator 
 
Affiliations:  
University of Michigan, School of Public Health 
 
Contact:  
 
jscottr@umich.edu 
 
Roles & Responsibilities: 
Design conception and initiation 
Mentorship 
 
Mary Lesniak, B.S. (ML) – Research Associate 
 
Affiliations: 
 
University of Michigan, Department of Psychiatry 
 
Contact: 
 
marles@umich.edu 
 
Roles & Responsibilities: 
Preparation of protocol and revisions 
 
 
 
 
Managing correspondence with clinical trials office 
 
 
 
 
Preparation of study reports 
 
 
 
 
Preparation of manuscripts 
Recruitment and screening of patients 
 
 
 
 
Data collection  
 
 
 
 
Data entry, verification 
 
 
 
 
Statistical Analyses 
 
 
 
 
Regulatory and compliance management/adverse event reporting 
 
ARF conceived of the study, developed and refined the study protocol, and is responsible for study 
implementation, including data collection, entry, and management under the mentorship and direction of BMH 
and JSR and with assistance from ML. BMH will assist with development and psychometric evaluation of 
measures used in the study, as well as clinical characterization of participants. JSR will assist with 
development and adaptation of measures from the REVEAL study to the SHARE(D) Project, as well as 
integration of needs assessment information into Stage II feedback protocols. ARF will complete statistical 
analysis, prepare manuscripts and presentations, with editing input from BMH and JSR. ARF will manage the 
clinical trial registry, preparation of institutional review board materials, administrative duties, and 
auditing/reporting requirements for the various agencies associated with the study. 
 
 
 
Roles & Responsibilities – Sponsor(s)/Funder(s) 

This project was supported via an R03 award granted to ARF from the NIH/NIA. The funding source had no 
role in the design, execution, analyses, or interpretation of the study, nor will it have a role in the decision to 
submit results. 
 
 
 

SECTION 2: INTRODUCTION 
 
SECTION 2.1: Background & Rationale 
 
 As of 2018, an estimated 5.5 million Americans have late-onset dementia due to Alzheimer’s disease (DAT), 
and another 11.6 million have Mild Cognitive Impairment (MCI)1, with proportionately higher prevalence per 
capita in ethnic minorities1-2. Improved knowledge of health and lifestyle contributions to DAT trajectories have 
made early detection and disclosure of DAT risk a priority for researchers and clinicians alike. In fact, early 
disclosure of elevated risk would save an estimated $172,000 per patient3 and $8 trillion nationally1 in 
healthcare costs via health behavior change and long-term planning. Given that African Americans incur 
significantly higher dementia-related costs than any other demographic4, early DAT risk feedback could be 
proportionately more beneficial for this population, yet occurs less frequently in these communities5.  
 
Literature suggests that between 50-90% of individuals are interested in receiving dementia risk feedback6,7. In 
this context, there is a gap between the rapid advancement of techniques to quantify DAT risk8 and 
development of empirically-supported methods to communicate this information to patients. A survey of the 
current AD risk disclosure literature revealed three critical knowledge gaps that build on our experience and 
inform the aims of this project.  
 
Need 1: Feedback regarding personal DAT risk is undermined by a lack of knowledge about the type(s) 
of information patients and their families want to receive - and why. With the acceptance of the Amyloid-
Tau-Neurodegeneration (A/T/N) model of Alzheimer’s disease (AD)9, there is increased focus on how 
biomarkers may increase risk for the phenotypic presentation of AD (i.e., DAT). Advanced methods of 
detecting AD-related changes in genes, brain structure and function, biomarker burden, and cognition have 
expanded our ability to predict an individual’s risk for future decline8,10-11. However, little is known about 
whether patients would prefer to receive this more advanced (but experimental) information, as opposed to 
clinically-available (i.e., familiar) information. Most published studies in this area disclose DAT risk based on 
data gathered in clinical visits, such as family and personal medical history, subjective symptoms, and 
cognitive screening or neuropsychological testing. These studies have found that the vast majority of 
participants are interested in this feedback for long-term planning purposes6,7.  
 
Among biological risk factors, apolipoprotein episilon-4 (APOe4) allelic status8,12 and positron emission 
tomography (PET) based amyloid burden5,7,13-15 have received the most attention in the risk disclosure 
literature, albeit in cognitively healthy individuals primarily. These studies indicate that patients’ desire for risk 
information is high but varies as a function of how much they know about DAT and AD biomarkers16-18. There 
exists great variability in reasons for requesting risk disclosure, ranging from basic curiosity to family planning6-
7,16-17. Additionally, post-disclosure, even cognitively healthy participants have difficulty understanding feedback 
language (e.g., interpreting a “positive” biomarker as a “good” outcome12). Comparing across these single-
source risk disclosure studies may be misleading, however, as none have directly compared what type of 
feedback patients would want to receive given a menu of all possible risk factors. In the absence of such a 
study, we suggest that clinical, genetic, and biomarker feedback is likely to be processed differently by 
patients. Genotype and family history are static, representing non-modifiable susceptibility. Cognitive test 
scores represent concrete measurements of changes that may already be apparent to patients and caregivers. 
In contrast, biomarkers are unfamiliar measurements of the individual’s underlying level of AD pathology and 
are probabilistic rather than deterministic for a diagnosis of DAT. In light of these differences, the need to 
compare patient preferences for different sources of risk feedback is critical. 
 
Advancement 1: This study will conduct a needs assessment of diverse patients’ and informants’ risk 
disclosure preferences. Aim 1 will evaluate patient and informant preferences for different sources of 
information used to determine DAT risk (see Table 1). Our inclusion of both patients and informants is 
especially relevant given our19 and others’20-22 work showing discrepancies in self- and informant-rated 
cognitive deficits. The proposed project will include a sample that is racially diverse (see Advancement 2), 
unlike prior studies that have focused primarily on White older adults. Furthermore, the sample will include both 
cognitively symptomatic (MCI) and intact older adults, rather than focusing on healthy populations alone. 
Results will describe the unique disclosure needs of African-American and White participants and their 
families. 

 
Need 2: To date, most feedback protocols have taken a 
one-size fits all approach to DAT risk disclosure, ignoring 
known strengths and challenges faced by racial-ethnic 
minority populations. Not only must we understand the 
type and amount of information patients want during DAT 
risk disclosure (Advancement 1), but also how and why 
racial groups differ in their preferences. Discussions of 
racial disparities in DAT prevalence tend to focus only on 
differences in biological risk factors (e.g., genetics, 
cardiovascular health), ignoring the complex epigenetic 
interplay between biology and environment. Sociocultural 
and socioeconomic differences (i.e., early educational 
differences, bias in cognitive testing, delayed/inadequate 
health care services, cultural stigma surrounding 
diagnosis) account for significant variance in DAT 
diagnosis and treatment in minority populations, even 
after controlling for biological risk factors2. One such 
sociocultural difference may be the extent to which African American individuals request, have access to, and 
utilize DAT risk disclosure in early stages of the AD course. The sparse literature on the topic indicates that 
African Americans may be less interested in DAT risk feedback23, yet reasons why are unknown. Greater 
understanding of African-American perspectives on risk disclosure will facilitate better communication and 
treatment, which in turn may alleviate the larger health disparities faced by this population.  
 
Advancement 2: The proposed needs assessment will investigate recipient-specific factors that 
influence DAT risk disclosure preferences in African-American and White participants and informants. 
The few studies examining risk disclosure preferences in non-White populations16-17,23-24 suggest that African-
American individuals are more likely than White counterparts to decline feedback about DAT risk. More 
nuanced preferences about amount, type, and reasons for feedback in African-American versus White 
participants remain unknown. Similarly, the reasons behind this discrepancy have never been directly studied. 
For White participants, personal characteristics such as general or dementia-specific anxiety6,18,24,25 and 
knowledge of AD biomarkers, symptoms, course, treatments24,25 influence preferences for type and amount of 
feedback. These same factors – perceived vulnerability to DAT and DAT knowledge – appear to be lower in 
African-American individuals24 but it is unclear if these group differences drive the decreased desire for DAT 
risk disclosure. We will directly evaluate patient characteristics that contribute to feedback preferences in a 
sample of African-American and White participants using an application of the Health Belief Model (HBM)26. 
More specifically, we will study how perceived vulnerability to DAT, perceived seriousness of DAT, perceived 
benefits of DAT risk disclosure, and perceived barriers to effectively using DAT risk information shape 
feedback preferences.  
 
Need 3: Our ability to effectively communicate DAT risk to participants and informants is limited by a 
lack of empirically-supported methods that integrate multiple risk factors. Existing studies have often 
taken a “siloed” approach that fails to integrate the multiple sources of DAT risk. Several studies have analyzed 
pre-disclosure desire to learn about a specific risk factor6,7,16-18, or reactions to real12 or simulated12 single-
source risk disclosure. Many provide guidelines for single risk-factor feedback7,12,27-30, though these 
suggestions are abstract and drawn from investigations of mostly White, highly educated participants. To date, 
no study has developed a feedback protocol that integrates multiple DAT risk factors (clinical, genetic, 
neuroimaging, and biomarker) and can be adapted to meet the needs of racially diverse patients.  
 
Advancement 3: This study will produce preliminary person-centered, culturally-informed protocols for 
communicating multi-factorial DAT risk, with specific adaptations in style or content based on patient-
specific factors. Aim 2 will integrate the results of the existing literature and the Aim 1 needs assessment into 
practical feedback protocols, with initial piloting. Our approach not only attempts to replicate prior findings on 
psychological reactions to risk disclosure, but also extends the literature (a) by assessing protocol 
effectiveness in terms of patient and informant comprehension, recall, and satisfaction (exploratory), and (b) by 
comparing African American and White older adults’ reactions to feedback. The project will result in a 

preliminary series of standardized protocols with specified adaptations (e.g., additional psychoeducation 
modules or language changes for impaired individuals) that can be integrated based on individual needs. 
 
 
SECTION 2.2: Objectives & Hypotheses of the pilot study 
 
Objective 1: to investigate the preferences and needs of racially diverse participants, and their 
respective informants, in regards to receiving feedback about their risk for DAT. We will leverage the 
robust Michigan Alzheimer’s Disease Research Center (MADRC) infrastructure to recruit older adults who are 
asymptomatic (i.e., cognitively intact) or in the early stage of disease progression (Mild Cognitive Impairment 
[MCI]), half of whom will be African American. Utilizing mixed qualitative and quantitative methods in the Stage 
I Needs Assessment, we will systematically evaluate three questions: 
 
1.1 Do African-American and White participants or co-participants differ in their interest in receiving 
certain types of DAT risk information? The study will evaluate group differences in participant and co-
participant interest in and actual preference for feedback at five levels: (1) no information about AD risk, or risk 
information based on (2) standard clinical measures, (3) genetic information, (4) quantitative structural 
neuroimaging, (5) amyloid and tau PET. Exploratory analyses will assess whether group differences also exist 
based on clinical research diagnosis (normal vs. MCI), and whether participants and their co-participants 
agree. 
1.2 Do African-American and White participants or co-participants differ in their perspectives 
on/rationale for certain types of DAT risk feedback? This study will assess whether African-American and 
White participants and co-participants identify different primary reasons for risk disclosure (i.e., basic curiosity, 
emotional reason, financial planning, medical planning, legal planning, social/family planning, or other). 
Exploratory analyses will assess whether group differences also exist based on clinical research diagnosis 
(normal vs. MCI), and whether participants and their co-participants agree. 
1.3 Which characteristics predict risk disclosure interest in African-American vs. White participants 
and co-participants? This study will evaluate whether African-American and White participants and co-
participants differ in their perceived threat of DAT, perceived benefits of risk disclosure, and perceived barriers 
to using risk information. We will also determine whether different factors (including personal demographic 
characteristics and the aforementioned perceived threat, benefits, and barriers) predict risk disclosure interest 
in different groups. Exploratory analyses will assess whether group differences also exist based on clinical 
research diagnosis (normal vs. MCI), and whether participants and their co-participants agree. 
1.4 Which components of feedback do African-American and White participants or co-participants see 
as most important? This study will evaluate whether African-American and White participants and co-
participants differ in their perspectives on the relative importance of different component of risk disclosure (e.g., 
educational materials, visual aids, follow-up coordination with providers). Exploratory analyses will assess 
whether group differences also exist based on clinical research diagnosis (normal vs. MCI), and whether 
participants and their co-participants agree. 
Objective 2: to develop person-centered, culturally-informed protocols for disclosure of different 
combinations of Alzheimer’s dementia risk factors. Building on the results of Objective 1, we will produce 
protocols for communication of DAT risk, with attention to specific adaptations in style or content based on the 
above noted individual factors. In particular, protocols will specify (a) effective methods of communicating risk 
conferred by each data source, (b) information designed for patients versus informants, (c) psychoeducation 
needs, and (d) resource/support needs. Through piloting in Stage II, we will evaluate three outcomes in both 
participants (those receiving the feedback) and co-participants: 
2.1 Comprehension and recall of personal risk disclosure information 
2.2 Psychological reactions to personal risk disclosure information 
2.3 Satisfaction with the feedback process (exploratory) 

 
SECTION 2.3: Trial Design 
The Stage I Needs Assessment is an observational study with no intervention or randomization. Stage II will 
involve a clinical trial, with the risk disclosure feedback serving as the behavioral intervention. The study will 
use a single-group design. All 10 participant-co-participant dyads (5 Non-Hispanic African-American, 5 Non-
Hispanic White) will receive feedback about the participant’s DAT risk. Outcomes will be measured 
immediately following feedback and at 1- and 6-weeks following risk disclosure. For more information 
regarding design, see Methods section. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

SECTION 3: METHODS 
 
SECTION 3.1 Participants: Inclusion & Exclusion Criteria 
 
3.1.1 Stage I 
 
Participants (those identified as the person who would hypothetically receive DAT risk feedback) will 
be recruited from the Michigan Alzheimer’s Disease Research Center’s University of Michigan Memory 
and Aging Project (UM-MAP), Testing High Definition transcranial Direct Current Stimulation (HD-tDCS) 
as Treatment of Mild Cognitive Impairment Project (STIM), or Dementia in African American Population 
Phenotyping from Potential Elevated Risk (DAPPER) project. 
 
Participants will include up to 60 older adults, age 65+ years who have completed an initial evaluation 
as part of the University of Michigan Memory and Aging Project (UM-MAP), the Testing High Definition 
transcranial Direct Current Stimulation (HD-tDCS) as Treatment of Mild Cognitive Impairment (STIM) 
project, or as part of the Dementia in African American Population Phenotyping from Potential Elevated 
Risk (DAPPER) project. Consistent with the diversity-related goals of this study, 25 of these participants 
will be self-reported Non-Hispanic African-American, and 25 will be self-reported Non-Hispanic White. 
As exploratory analyses will look at the role of cognitive impairment, approximately 50% of the sample 
will be consensus-diagnosed as either cognitive healthy or with Mild Cognitive Impairment (MCI; single- 
or –multiple domain, amnestic or non-amnestic forms) through their participation in UM-MAP, STIM, or 
DAPPER. Exclusion criteria include current or historical neurologic disorder (e.g., Alzheimer’s dementia 
or other neurodegenerative dementia, Parkinson’s disease, seizure disorder, tumor, multiple sclerosis) 
or neurologic injury (e.g., significant stroke or moderate-severe head injury, defined by loss of 
consciousness > 5 minutes, presence of significant post-traumatic amnesia, or the need for extended 
hospitalization or intervention). Participants with motor symptoms indicative of a neurodegenerative 
etiology other than Alzheimer’s disease will also be excluded. Participants with severe mental illness 
(i.e., bipolar disorder, thought disorder, psychosis) or anyone deemed to meet criteria for current 
substance use disorder will be ineligible for participation in this study. 
 
Co-Participants (those who are currently serving as a caregiver to the participant, or would 
hypothetically serve in this role should the need arise) include up to 60 adults, age 18+ years. Co-
participants must be cognitively healthy, as defined by consensus diagnosis if they are also enrolled in 
UM-MAP, STIM, or DAPPER, by neuropsychological evaluation within 12 months of study participation, 
or by cognitive screening (MoCA) prior to study enrollment. As it is critical that co-participants can 
reliably and validly report on their perspectives or thoughts about their respective participants, co-
participants must have known the participant for ≥5 years and have at least weekly phone or in-person 
contact with the participant.  
 
3.1.2 Stage II 
 
Participants (those identified as the person to receive DAT risk feedback) will include a subset of 10 
older adults (65+) drawn from the Stage I Needs Assessment, all of whom have available 
neuropsychological performance information, magnetic resonance imaging (structural) information, 
positron emission tomography (PET) amyloid and/or tau information, and apolipoprotein e genetic 
information already collected as part of UM-MAP, STIM, or DAPPER. Participants will meet all of the 
inclusion/exclusion criteria applicable for Stage I. Additionally, participants must be negative for mood 
or anxiety diagnosis and negative on mood measures prior to enrollment in Stage II. Participants must 
also be currently followed by a medical provider (primary care physician, geriatrician, family doctor). 
These additional inclusion criteria minimize the likelihood of significant psychological risks following 
feedback, and facilitate clinical coordination of care between study staff and clinical providers in the 
event that significant psychological distress does occur. 
 
Co-Participants (those who are currently serving as a caregiver to the participant, or would 
hypothetically serve in this role should the need arise) include 10 adults, age 18+ years. Similarly, 
participants must meet criteria from the Stage I Needs Assessment. Additionally, if the participant has 

an active legally authorized representative (LAR) or power of attorney (POA) for medical decisions 
and/or research, that individual must serve in the role of co-participant, and must provide 
documentation of this legal designation prior to enrollment of the dyad in the study. If the participant 
does not have an enacted LAR/POA, any individual meeting the above criteria can serve as the co-
participant. 
 
All study-related activities will occur at the University of Michigan through virtual visits. 
 
SECTION 3.2 Recruitment Strategy 
 
3.2.1 Stage I: Participants will be recruited from UM-MAP, STIM, or DAPPER. The MADC recruits 
participants from several sources including the MADC Memory Disorders clinic, community screening 
events, and external referrals. UM-MAP, STIM, or DAPPER participants interested in research are 
maintained in an IRB-approved database, which is available by request to the PI and her study team.  
 
3.2.2 Stage II: Participants will be recruited to Stage II through invitation, only. The study team will 
review dyads who complete the Stage I Needs Assessment, screen these cases for any interim 
changes that might impact eligibility of the participant or co-participant, and contact dyads to determine 
interest in engaging in the second stage of the study. Specifically, following Stage I, the study team will 
contact the parent studies (UM-MAP, STIM, and DAPPER) via the MADRC ‘cohort discovery’ data 
request pipeline to confirm who among the list of interested Stage I participants have (a) annual 
research evaluation information with resulting cognitively normal or mild cognitive impairment 
diagnosis, and (b) at least one of the following: PET amyloid and tau biomarker data, apolipoprotein E 
genotype, or Neuroquant volumetric neuroimaging from MRI. Of note, none of these biomarker data will 
actually be accessed by the SHARE(D) research team for recruitment; the actual biomarker and 
personal health data will be requested only following informed consent from the participant and co-
participant.  
 
 
 
 
 

SECTION 3.3 Procedures 
 
3.3.1 Stage I – for a visual timeline 
of Stage I Activities, see Figure 1. 
 
 
Session Description: 
 
After telephone screening for 
eligibility, participants will be 
scheduled for a study session 
(ideally in parallel) within 
approximately one week as 
availability allows. This session will 
be 90-to-120-minutes, one-on-one 
with a study team member.  
 
In March 2020, the global Covid-19 
pandemic resulted in research 
ramp-down and restrictions on in-
person research visits. To protect 
the health of our participants, 
particularly given their vulnerable 
status as older adults, we 
determined that it would be best not 
to continue in-person research 
visits, and to instead adapt this 
protocol to allow for virtual visits. 
Therefore, during telephone 
screening, participants will be 
offered the opportunity to complete 
the Stage I session as a video or 
phone visit. Interested participants 
will be asked whether they have 
adequate access to and familiarity 
with a laptop, tablet, or computer to 
engage in a video visit session in 
which they will complete 
questionnaires and interviews using 
video-conferencing software. 
Participants who do not have 
access to this technology or do not feel comfortable completing the visit over video will be offered the 
opportunity to complete the session over the phone. Those that decline phone or video visit, but remain 
interested in the study will be deferred for scheduling until a time that it is deemed safe by research 
administration for participants to engage in in-person research. 
 
In-Person Sessions: At the initiation of the session, participants/co-participants will complete written 
informed consent and the decision-making tool to ensure that they are cognitively capable of doing so. 
Additional screening criteria will then be reviewed. Co-participants without recent neuropsychological or 
cognitive evaluation (within 6 months) will also be screened using the MoCA.  
 
Video Conferencing Sessions: Participants and Co-Participants who are interested in engaging in a 
video visit will be asked about their access to and comfort with technology for the session prior to 
scheduling. Participants and Co-Participants must utilize a desktop or laptop computer, or a tablet with 
a screen at least 9.7 inches in diagonal width to ensure that they are able to view the questions 
completely. Additionally, participants/co-participants must have access to a stable, secure internet 
connection (not public wi-fi) and a quiet, private space where they will be uninterrupted for the duration 
Figure XX. Stage I Timeline of Activities 
Figure 1. 
Stage I 
Timeline of 
Activities 

of the 2-hour appointment. Participants and Co-Participants who meet the above criteria will be sent 
separate links to engage in a secure video conference session through the BlueJeans or Zoom for 
Health applications. Both applications are free, HIPAA-compliant services. 
 
Phone Conferencing Sessions: Participants/co-participants who are interested in engaging in a virtual 
visit but do not have access to the required technology or otherwise feel uncomfortable with a video 
visit will be offered the opportunity to complete the session via phone.  
 
Informed Consent for Virtual Visits: The informed consent document will be emailed to 
participants and co-participants at the time of scheduling, to provide the recipient enough time to 
review the document. Prior to other study activities, a study team member will set up a phone 
call to review the consent paperwork together. At this phone appointment, a study team member 
will explain each section of the informed consent document, pausing to answer questions or 
clarify misunderstandings. In parallel with the procedures used in in-person sessions, the study 
team member will also use the Decision-Making Capacity Tool to ensure that the individual 
providing consent is able to fully understand the decision he/she is making prior to providing 
consent. After the informed consent document has been reviewed, eligible participants/co-
participants will be asked to provide electronic signature on this form. This can be completed 
through two methods: (a) the patient can download, sign, scan, and email the form back to the 
study team member, who will additionally sign as witness and study representative, or (b) the 
Signnow platform will be used to provide electronic consent. SignNow is a secure platform 
offered through University of Michigan, which is HIPAA-compliant and approved by Health 
Information Technology Services (HITS). A copy of the form, with all signatures, will be emailed 
to the participant/co-participant. 
 
Co-Participant Screening for Virtual Visits: As noted above, all co-participants must be 
cognitively intact based on screening or recent evaluation. In lieu of in-person screening, co-
participants will be asked to complete a brief phone or video screen (the Blind version of the 
Montreal Cognitive Assessment [MoCA]) after informed consent, but prior to other study 
activities. As with in-person visits, co-participants whose scores fall below the cutoff for 
impairment will be considered ineligible for study participation. Their respective participants will 
also be asked to delay scheduling of their virtual visit until they can identify another interested 
and eligible co-participant. 
 
Ineligible participants or co-participants will be excluded, but paid for their time. Eligible participants and 
co-participants will be included in the research study, and will continue the session to complete 
questionnaires and a semi-structured interview. The semi-structured interview will be recorded, as the 
qualitative responses from participants/co-participants will be analyzed as secondary outcomes in th 
study. In-person sessions are recorded using a secure, HIPAA-compliant voice recorder, with all 
sessions transferred to a secure drive, password protected, and deleted from these recorders 
immediately after the session. Virtual visit interviews will be recorded using BlueJeans, Zoom for 
Health, or using the voice recorder with the phone call on speakerphone; similarly, these audio files will 
be de-identified, transferred to a secure drive, and password protected. Participants and co-participants 
will also complete a Beck Anxiety Inventory and Geriatric Depression Scale – 15 Item after these 
procedures, in order to monitor anxiety and mood (see Section 3.5.1 Monitoring). All in-person sessions 
will take place in the PI’s (ARF) laboratory at the University of Michigan. All virtual sessions will be 
completed by study team members either at the Rahman laboratory, or in a secure, private location. 
Individuals will receive $20 compensation for their participation in the study, paid via check after the 
session.  
 
Conceptual Model. The conceptual model for understanding feedback preferences is adapted from the 
Health Belief Model30, (Figure 1). The resulting model contains three domains: 1) Perceived Threat of 
AD (i.e., perceived vulnerability to and seriousness of an AD diagnosis); 2) Feedback Expectancies 

(i.e., rationale for learning 
about risk, perceived 
barriers to learning about 
or dealing with risk 
information); and 3) 
Feedback Preferences 
(i.e., the type of risk 
disclosure desired).  
 
Primary Outcomes: 
 
Questionnaires: In 
addition to the qualitative 
information gathered 
during the semi-
structured interviews (see below), several formal questionnaires will be administered to provide 
quantitative information: 
 
HBM Components. We have developed the Anticipatory Dementia Inventory (ADI), a 50-item 
Likert-style measure of DAT-specific worry based on the HBM. Items relate to perceived 
vulnerability to DAT, perceived seriousness of a diagnosis, and expectations about ability to 
deal with a diagnosis, with responses ranging from strongly disagree to strongly agree. This 
measure has previously been validated for use with racially diverse older adults through the PI’s 
graduate work (paper in preparation).  
 
Knowledge of AD/DAT. DAT knowledge will be measured through a multiple-choice quiz about 
DAT symptoms, course, causes, treatments, and risk factors. This quiz will be developed in 
Quarter 1 of the first funding year via monthly study-team meetings.  
 
Risk Disclosure Interest and Preferences. In addition to the open-ended preference/rationale 
questions administered in the interview, we will utilize a questionnaire asking participants and 
co-participants to rate their level of interest in receiving feedback based on each risk factor 
(Table 3; e.g., “How interested are you in knowing about your/your family member’s risk for 
Alzheimer’s Dementia based on your genotype?”), on a continuous scale ranging from 1 (no 
interest) to 5 (very interested). Participants and co-participants will also use a checklist to state 
which information they would want to receive, selecting as many of the DAT risk information 
sources as desired (e.g., “Would you choose to receive feedback about your/your family 
member’s risk for DAT based on genotype? Yes or No?”) 
 
Risk Disclosure Rationale. Participants will also be provided with a list of reasons for risk 
disclosure cited in prior literature and asked to rank the primary reason/purpose for risk 
disclosure. 
 
Importance of Risk Disclosure Elements. Participants and co-participants will also complete a 
questionnaire asking them to rate the importance of different empirically supported elements of 
risk disclosure protocols cited in the published literature (e.g., How important do you think it is 
that educational materials are provided as part of your risk disclosure feedback?). Responses 
will be on a continuous scale from 1 (not at all important) to 5 (extremely important). 
 
The order of questionnaires and interview questions will be counter-balanced to avoid potential 
reciprocal priming effects (e.g., discussing perceived vulnerability to DAT may influence feedback 
preferences).   
 
For video sessions, the above questionnaires will be presented as Microsoft Powerpoint slide shows, 
with one question on each slide. The study team member will share his/her screen, and advance the 
slideshow, asking each questions clearly, to facilitate ease of comprehension for participants. 
Figure 2. Conceptual Model for Risk Disclosure Preferences 

 
Secondary Outcomes:  
 
Semi-Structured Interviews: Although the quantitative methods above will be the primary source of 
information for the current project, we believe that the inclusion of qualitative methods will provide 
richness and context to the results. Furthermore, the inclusion of open-ended questions and qualitative 
coding methods will remove bias against minorities implicit in validated measures and allow for 
identification of risk disclosure concepts or perspectives not covered in these measures.  The 
interviews will incorporate risk disclosure questions adapted from Co-Investigator Roberts’ Risk 
Evaluation and Education in Alzheimer’s Disease (REVEAL) Study, a successful multi-site trial of risk 
disclosure needs in older adults. We will also include novel questions that relate to the three domains of 
the HBM to study patient and co-participant characteristics that influence preferences. During the 
interview, they will have the opportunity to freely discuss what sources of DAT risk they would prefer to 
receive about themselves or, in the case of co-participants, about their loved ones, and how they plan 
to use that specific risk information. This open-ended approach will not limit responses to only 
presumed reasons for risk disclosure drawn from the past literature.  
 
 
3.3.2 Stage II - for a visual timeline of Stage II Activities, see Figure 3. 
 
Preliminary Screening: Following study team review of the participant’s and co-participant’s medical 
record to ensure no interim changes make either part ineligible, the study team will also access the 
participant’s prior MADRC study involvement to determine whether they have adequate information for 
risk disclosure. Specifically, the study team will communicate with the MADRC UMMAP, STIM, and 
DAPPER teams to determine if the participant has (a) complete cognitive testing and research 
diagnosis and (b) recent (within 12 months) data for at least one additional biomarker, including MRI 
Neuroquant reports, PET amyloid and tau, or APOE genetic results. If the participant meets these 
criteria, the study team will send an email introducing the study (see ‘SHARE(D)’ Stage II Email Script’) 
and begin contacting the participant via phone (see ‘SHARE(D) Stage II Oral Script’).  
 
Informed Consent for Virtual Visits: The informed consent document will be emailed to participants and  
co-participants at the time of scheduling, to provide the recipient enough time to review the document. 
Prior to other study activities, a study team member will set up a phone call or video session to review 
the consent paperwork together. At this phone appointment, a study team member will explain each 
section of the informed consent document, pausing to answer questions or clarify misunderstandings. 
The study team member will also use the Consent Decision-Making Capacity Tool to ensure that the 
individual providing consent is able to fully understand the decision they are making prior to providing 
consent. After the informed consent document has been reviewed, eligible participants/co-participants 
will be asked to provide electronic signature on this form. This can be completed through two methods: 
(a) the patient can download, sign, scan, and email the form back to the study team member, who will 
additionally sign as witness and study representative, or (b) the Signnow platform will be used to 
provide electronic consent. SignNow is a secure platform offered through University of Michigan, which 
is HIPAA-compliant and approved by Health Information Technology Services (HITS). A copy of the 
form, with all signatures, will be emailed to the participant/co-participant. Only following receipt of this 
informed consent document will actual biomarker data be requested and received from the parent study 
teams (UMMAP, STIM, DAPPER) for integration into the disclosure protocols. 
 
Additional Screening & Scheduling: Following receipt of the signed informed consent documents, both  
the participant and co-participant will be asked to complete the GDS-15 and BAI via phone or video 
(these can be conducted on the same call used to complete the consent documentation). Any 
individuals who score above the cutoffs for these measures will be ineligible to take part in the study, 
per eligibility criteria noted above. Additionally, all co-participants must be cognitively intact based on 
screening or recent evaluation. Co-participants who do not have recent screening or cognitive testing in 
their medical/research records will be asked to complete a brief phone or video screen (the Blind 
version of the Montreal Cognitive Assessment [MoCA]) on this call. Co-participants whose scores fall 
below the cutoff for impairment will be considered ineligible for study participation. Their respective 

participants will also be asked to delay 
scheduling of their virtual visit until they 
can identify another interested and 
eligible co-participant. Once this 
secondary screening of the dyad has 
been completed, the study team will 
schedule all three sessions for each 
subject. 
 
Session Description: 
 
Education & Disclosure Session: 
 
During this session, participants and 
co-participants will complete the 
follo.wing steps, summarized in Table 
2: 
 
1. Educational Module – participants 
and co-participants will be shown an 
interactive presentation covering the 
following topics: 
 
a. Alzheimer’s disease 
 
b. Dementia-Alzheimer’s Type 
 
c. Available treatments for AD/DAT 
 
d. Available biomarkers or indicators of 
DAT risk: how they are collected, what 
information is shared, and what the 
meaning of this information is relative to 
risk for AD and DAT 
 
e. Risks of learning one’s personal 
DAT biomarker status 
 
f. Benefits of learning one’s personal 
DAT biomarker status 
 
This module will include multiple 
opportunities for either member of the 
dyad to ask questions.  
 
2. Disclosure Preferences & Decision-
Making Capacity Assessment – The 
educational module contains several 
‘checks for understanding’ after each 
section to determine whether the 
participant fully demonstrates decision-
making capacity for risk disclosure. As 
per the Disclosure Decision-Making Assessment Tool (DDMAT), the study team member will make 
notes about the participant’s responses, provide corrections, clarifications, or prompts if needed, re-
assess after this additional information has been provided, and then assess whether the ultimate 
Figure 3. SHARE(D) Stage II Timeline of Activities 

response demonstrates full understanding, appreciation, rationale, and communication (elements of 
decision-making capacity). 
 
Of note, if the participant has a LAR/POA co-participant, that individual must demonstrate decision 
making capacity for the participant to receive risk disclosure, and agree with this decision. 
Regardless of whether the LAR/POA wants the participant to complete risk disclosure, the study 
team will not move forward with sharing the participant’s risk information with either party unless 
assent is provided by the participant. 
 
If the participant or designated LAR/POA does not demonstrate full decision making capacity, the 
study team will not move forward with risk disclosure, and the dyad’s involvement in the study will 
be complete. 
 
3. Risk Disclosure: the study team have developed a flexible disclosure protocol that provides written 
and graphic representations of the participant’s health information and risk indicators. The protocol 
will be adapted using standardized instructions prior to the session, to personalize each protocol to 
the participant. Personalization will be based on demographic factors and geographic location of the 
patient’s home (to ensure identified resources are close by and accessible), and research diagnosis 
and level of risk (to ensure that appropriate recommendations and resources are given). 
Additionally, we will adapt the protocol based on which of the following indicators the participant 
and/or LAR/POA requested after the education module (provided these are available from prior 
study participation): 
 
• 
DAT risk based on standard clinical procedures: a review of cognitive strengths, weaknesses, 
and impairments relative to age-, sex- and/or race-matched normative data (using qualitative 
ranges from severely impaired to above average), in the context of the participant’s medical and 
family history; disclosure of clinical research diagnosis (cognitively healthy or MCI); qualitative 
discussion about the increased risk for conversion to dementia based on an MCI diagnosis 
• 
AD risk based on apolipoprotein-e ε4 genotype: disclosure of genotype (ε4 positive 
[homozygous/heterozygous] or negative); quantitative (percent or odds ratio) risk for Alzheimer’s 
disease based on lifetime cumulative risk curves integrating race, gender, and genotype information 
(REVEAL study31) 
• 
AD risk based on structural T1/T2/FLAIR magnetic resonance imaging (MRI)*: quantitatively 
graded interpretation of atrophy (primarily in mesial temporal structures) based on age- and sex-
matched normative comparisons drawn from the Neuroquant/Lesionquant program (Cortech labs: 
https://www.cortechslabs.com/products/neuroquant/); disclosure of any incidental findings; 
qualitative discussion regarding risk of underlying AD pathology based on imaging, and associated 
potential for DAT. 
• 
AD risk based on positron emission tomography (PET) amyloid and tau*: qualitative 
interpretation (i.e., Elevated vs. Not Elevated) of the presence or absence of significant burden for 
either of the abnormal proteins; discussion that elevation on either/both proteins may indicate 
underlying AD pathology that may or may not develop into DAT. 
 
*Given the lack of validated quantitative models of DAT risk conferred by these factors8, only 
qualitative information regarding risk for developing or converting to DAT (the phenotypic 
presentation of AD) will be provided at this time. Particular attention will be given to differentiating 
the presence of AD pathology (i.e., positive amyloid and tau burden or indications of significant 
atrophy) from the actual development of symptoms (aMCI, DAT). 
 
The disclosure protocol includes a summary of the above indicators; however, no summative or 
combined risk estimate is provided, as such an estimate is not empirically supported. Following this 
summary, the protocol includes general recommendations and next steps for healthy aging (e.g., 
taking care of physical and emotional health, staying cognitively and socially engaged) and a list of 
informational and support resources. As with the Education Module, the disclosure protocol will 
include multiple ‘checks for understanding’ after each section to ensure that information 
communicated is being comprehended accurately by the participant and co-participant. 

 
4. Immediately following risk disclosure, the participant and co-participant will complete outcome 
measures and a brief psychological risk assessment with a clinical psychologist utilizing the recall 
assessment and impact of events scale documents. Both parties will also complete a checklist of 
requested resources or supports from the region- and service-specific list developed in SHARED 
Stage I. Participants and/or LAR/POAs will also be asked whether they would like a written 
summary of the information provided; if so, this report will be prepared after the visit and sent via 
mail to the participant or LAR/POA. No results will be uploaded in the participant’s medical record; 
however, they are welcome to share the results with their medical providers independently.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-Up Sessions:  
 
Outcome measures and psychologist risk assessment will also be repeated at 1-week and 6-weeks  
post-feedback. Participants and co-participants will also be encouraged to call the PI (ARF) or ML  with 
any additional concerns or questions between these sessions. All sessions will take place in via phone 
or virtual visit. Participants and/or co-participants who complete some but not all sessions will receive 
pro-rated payment ($10 per session, $30 total), paid as a check after the sessions. 
 
 
 
Primary Outcomes 
 
Comprehension and recall of personal risk disclosure information will be measured as accuracy 
scores on a series questions about the patient’s results and the meaning of different messages 
provided during feedback in regards to AD/DAT risk (i.e., “My Attention was [Normal/Impaired/Don’t 
Know]”). The questionnaire will result in two scores: a Personal Information score and a Meaning of 
Information score (as it is possible that an individual may accurately remember his/her own information, 
but misinterpret it, or may understand the meaning of risk information, but incorrectly recall his/her own 
feedback). 
 
Psychological reactions to personal risk disclosure information will be measured both in terms of 
general mood and anxiety, as well as feedback-specific distress.  
 
Depression: Mood will be assessed using the self-administered Geriatric Depression Scale – 
Short Form (GDS-15)32-33. The GDS-15, a 15-item assessment of depressive symptoms, has 
been adapted to remove common depression symptoms often conflated with normal aging (i.e., 
Table 2. Proposed Order & Components of Disclosure Sessions 
1. Initial Consent 
2. Education Module 
3. Assessment of Disclosure Preferences 
4. Assessment of Disclosure Decision-Making Capacity 
5. Personal Risk Disclosure 
    - Clinical Predictors of DAT Stage (Cognitive Testing, Research 
Diagnosis) 
    - Structural MRI-conferred AD Risk (qualitative) 
    - APOE-conferred AD Risk (quantitative) 
    - PET Amyloid and Tau-conferred AD risk (qualitative) 
6. Recommendations 
7. Participant & Caregiver Resources  
8. Risk Assessment & Follow-Up (as needed) 
9. Outcomes Assessment 
    - Comprehension  
    - Mood/Psychological 
    Satisfaction (exploratory) 

somatic symptoms). It asks the participant to rate the presence of mood symptoms over the 
past two weeks.  
 
Anxiety: The BAI34, also validated for use with older adults35 is a 21-item measure of the 
perceived severity (‘not at all’ to ‘severely’) at which the participant is experiencing anxiety 
symptoms over the past week.  
 
Feedback-Specific Distress: We will utilize a revised version of the Impact of Genetic Testing for 
Alzheimer’s Disease (IGT-AD) Scale, which itself is based on The Impact of Event Scale (IES) 
36. The scale will be specifically anchored to the ‘life event’ of receiving feedback; responses will 
be slightly modified to assess the impact of receiving any and all AD indicator results (not solely 
genetic information). The IES and IGT-AD have been utilized to measure test-related distress in 
previous risk disclosure studies37-39, including REVEAL. Participants who have a negative score 
of 24 or more will be contacted by PI for follow-up with participant/co-participant. 
 
Exploratory Outcomes 
 
Satisfaction with the feedback process will be evaluated by determining how well participants’ and 
informants’ pre-test expectations are met. We will collect subjective, open-ended qualitative ratings of 
the utility of risk assessment using questions developed in the REVEAL study, such as “What was the 
overall impact that your risk information had on you?”, “Would you recommend risk assessment for AD 
to your family or friends?”, and “If you had it to do over again, would you choose to have risk 
assessment for AD?”  
 
SECTION 3.4 DATA MANAGEMENT & ANALYSIS 
 
3.4.1 Data Management & Entry 
 
Only IRB approved study personnel will have access to study documents/data. Signed consent paperwork and 
will be uploaded into the participant’s medical record according to IRB standards and then stored in a binder, 
separate from all other study data. Electronic consent forms will be saved under password protection on the 
secure lab drive. Copies will be printed and stored in the aforementioned binder, away from all other study 
data. Data are kept in a locked file cabinet within a private office in an office suite (i.e., behind two locked 
doors). The participant’s study ID number will be recorded on every paper page of the study documents.  
 
The participants’ biomarker data (beyond UM-MAP, STIM, or DAPPER diagnosis) will not be requested or 
stored as part of this study until completion of Stage I, to ensure no implicit bias in the manner in which needs 
assessment procedures are conducted based on participant risk. At this time, data from the 10 participants 
enrolled in the Stage II feedback piloting will be requested through the secure UM-MAP, STIM, or DAPPER 
Data Core avenue; de-identified participant information, coded with the UM-MAP, STIM, or DAPPER ID 
number, will be shared with the study team as a secure excel database. This file will reside on the University of 
Michigan secure server as a password protected file only accessible by approved study personnel. 
 
3.4.2 Statistical Design 
 
Data Screening (Stage I & II) 
 
Prior to statistical analyses, data screening will be conducted. Initial steps will include a missing data analysis 
to determine randomness of missing data and range checks to assess for data quality. Additional screening for 
univariate and multivariate outliers, skewness and kurtosis will be conducted to inform needs for data 
transformation and statistical approach. Additionally, for Stage I data, we will compare outcomes in participants 
who completed in-person vs. video vs. phone visits to ensure that session modality did not impact 
interpretation of results. 
 

Statistical Approach 
 
3.4.2.1 Stage I 
 
Primary Outcome 1.1 (Differences in risk disclosure interest and preferences): To analyze the 
dichotomous yes/no interest outcomes, chi-squared analyses will be used to compare the proportion of 
African-American and White participants who endorse interest in receiving feedback at each level, for 
caregivers and patients separately. Given that there are five levels of risk disclosure feedback, five 
comparisons will be conducted; to account for the relatively small sample size, a conservative 
Bonferroni correction for multiple comparisons will be implemented (α = .05/5 = .01). To analyze the 
Likert-style interest outcomes, either independent samples t-tests or Mann Whitney U tests will be used 
to compare mean interest level in African-American and White participants for each of the five risk 
disclosure levels, again using a Bonferroni correction. Further exploratory correlation analyses will 
determine agreement between caregiver and informant interest in African-American and White 
subgroups, separately. 
 
Primary Outcome 1.2 (Differences in risk disclosure rationale): This study will assess whether 
African-American and White participants and co-participants identify different primary reasons for risk 
disclosure (i.e., basic curiosity, emotional reason, financial planning, medical planning, legal planning, 
social/family planning, or other), a Fisher’s Exact test will be used, comparing frequency of reason 
endorsement. These analyses will be conducted for patients and informants separately; however, we 
will also explore agreement among dyad members. 
 
Primary Outcome 1.3 (Patient characteristics that influence preferences): We will utilize a 
regression approach to determining patient characteristics and perspectives that shape level of interest. 
More specifically, we will create mixed linear models to quantify the fixed effects of four sets of 
variables (participant factors [demographics, baseline anxiety and depression, DAT knowledge], ADI 
Perceived threat of DAT, ADI Perceived benefits of this level of risk disclosure, ADI Perceived barriers 
to using this risk information), as well as the random effects attributable to the dyadic relationship. This 
approach will allow us to calculate the intra-class correlations representative of the effect of the dyadic 
relationship. Furthermore, given the likely effect of dyadic role (‘patient’ or informant) on perceived 
threat, perceived benefits, and perceived barriers, the interaction terms (e.g., role by threat, role by 
benefits, role by barriers) will also be included in the model. It is expected that the effect of the dyadic 
relationship will be significant; therefore, additional subgroup analyses examining predictors of risk 
disclosure interest in caregivers and patients separately will be conducted.  
 
Primary Outcome 1.4 (Differences in importance of risk disclosure components): To analyze the 
Likert-style importance outcomes, either independent samples t-tests or Mann Whitney U tests will be 
used to compare mean interest level in African-American and White participants for each of the 
feedback components, again using a Bonferroni correction. Further exploratory correlation analyses will 
determine agreement between caregiver and informant interest in African-American and White 
subgroups, separately. 
 
Secondary Outcome (Qualitative Information from Semi-Structured Interviews): In combination 
with the semi-structured interviews, we will therefore record and transcribe the narrative responses of 
patients and caregivers. After basic ‘cleaning’ of the data (removal of articles, non-content utterances, 
and additional identified ‘stop’ words), the text will be analyzed using R Statistical Software for most 
commonly used words or phrases by race. A Topic Modeling approach (akin to an exploratory factor 
analysis for text analysis) will be utilized to identify central themes (the ‘factors’) and associated terms 
or phrases (the ‘items) by race. 
 
 
3.4.2.2 Stage II  
 
Given the nature of the study (pilot) and associated small sample size, descriptive statistics will be 
calculated, but no group comparisons will be completed. 

 
Primary Outcome 2.1 (Comprehension & Recall): The Personal Information and Meaning of 
Information accuracy scores will be totaled for all participants. Mean, median, and standard deviation 
will be calculated. Exploratory analyses will evaluate trends in whether specific types of feedback 
information (e.g., neuroimaging vs. amyloid/tau burden) were better understood than others, and 
whether group differences exist (i.e., participants vs. co-participants, by race, by cognitive status). 
 
Primary Outcome 2.2 (Psychological Reactions): Mean, median, and standard deviation of total 
scores on the GDS-15, BAI, and IES will be calculated. Change in total scores on the BAI and GDS-15 
will be calculated by comparing Stage II scores with Stage I screening scores. Descriptive statistics will 
also be calculated for these change scores.  
 
Secondary Outcome 2.3 (Satisfaction): Answers to the qualitative questions will be reviewed 
individually for suggestions and themes. 
 
SECTION 4: MONITORING 
 
4.1 Risk Monitoring 
 
4.1.1 Stage I  
 
It is not expected that discussing DAT risk disclosure preferences or needs will cause significant 
distress or exacerbation of mood symptoms; however, all participants in the Year 1 Needs Assessment 
will complete a brief measure of mood and anxiety, including the Geriatric Depression Scale – 15 Item 
version (GDS-15)1 and the Beck Anxiety Inventory (BAI)2 following participation in the semi-structured 
interview. A study team member will also be present in the room, or available virtually with the 
participant or co-participant for the entirety of the session to monitor distress. Each of the measures 
have empirically supported cut-off scores for determining clinically significant depression, anxiety, and 
event-related distress; individuals who endorse clinically significant depression or anxiety on the GDS-
15 or BAI at the end of the session, or who appeared distressed during the session, will undergo a risk 
assessment and follow-up (see below). The study safety plan to determine need for risk assessment or 
intervention is included in Appendix A. Of note, for video or phone sessions, at the start of each 
session, the participant/co-participant will be asked to provide a call-back number in case he/she is 
disconnected from the technology, as well as current location; this information will not be stored in the 
participant’s/co-participant’s file, but will be used as a reference in case of emergency or safety issue. 
 
4.1.2 Stage II 
 
It is possible that patient and informant participants may experience psychological distress as a result 
of hearing feedback about their current cognitive status and risk for developing DAT, particularly if the 
feedback indicates elevated risk. Although DAT risk disclosure has been found to be generally safe and 
well-tolerated in the literature3,4, we will conduct careful screening of mood, anxiety, and event-related 
distress utilizing psychometrically sound evaluations. Specifically, each participant and co-participant 
will repeat the GDS-15 and BAI, and complete the Impact of Event Scale (IES)5 at the Year 2 
disclosure session as well as at 1- and 6-week follow-up. Any clinically significant elevation of scores 
on the GDS-15 or BAI, a score of 24 or higher on the IES, and/or other indication of new or 
exacerbated mood symptoms will result in a more advanced evaluation during the feedback and follow-
up sessions (see Appendix A). In addition, participants and co-participants will be given contact 
information for the study team and encouraged to call ARF or ML with any concerns or needs related to 
their reactions to the disclosure session. 
 
4.2 Safety Assessment: In the case of safety concerns in either Stage, a risk assessment and follow-up will 
be conducted. A licensed psychologist (ARF, BMH, or JSR), who will be available during all sessions either in-
person or virtually, will evaluate the patient’s or informant’s severity of psychological symptoms and risk of self-
harm. The clinician will take additional action as needed to either provide immediate transfer to emergency 
care (in the case of active threat), or facilitation of clinical care or supportive resources, per participant request 

(in the absence of active threat). All participants will also be provided with emergency contact cards with local, 
24/7 resources if emergent mood issues arise between sessions. A summary of the project suicide safety plan 
is included in Appendix A. 
 
4.3 Adverse Events Reporting: Participant mood and distress will be carefully assessed for the 50 Year I 
dyads using the Geriatric Depression Scale – 15 Item version (GDS-5) and the Beck Anxiety Inventory (BAI). 
These measures, in addition to the Impact of Event Scale (IES), will be administered to the patient and 
informant dyads receiving pilot feedback in Year 2 to determine (a) whether changes in mood or distress occur, 
and (b) whether these changes are attributed to study participation. The GDS and BAI have empirically 
supported cut-off scores for determining clinically significant depression, anxiety; scores will therefore be used 
to define the nature of any events (unanticipated vs. anticipated, adverse vs. serious adverse) and relationship 
of these events to study participation (related vs. unrelated). The IES does not have a validated cutoff; 
however,  we will treat a score of 24 or higher as warranting additional study team follow-up. 
 
Information regarding non-serious adverse events (i.e., an elevation in mood or anxiety symptoms as a result 
of study participation) will be reported directly to the PI, who will compile and submit a report to independent 
Safety Officer (SO). The SO for this project is Joshua Grill (jgrill@hs.uci.edu).). Similarly, serious adverse 
events that are determined to be unrelated to study participation will be reported to the PI, recorded in a secure 
study database, and reported to the SO. These summary reports will be submitted to the SO on a quarterly 
basis. 
 
Unanticipated adverse events or serious adverse events deemed related to study participation (i.e., acute 
exacerbation or onset of severe depression or anxiety, hospitalization for emotional reasons, and/or 
preparation for or engagement in self-injurious behavior as a result of risk disclosure results) will be reported 
immediately to the study PI. Consistent with Office of Human Research Protection, Institutional Review Board 
guidelines for the study’s parent institution, and NIA standards, serious study-related adverse events resulting 
in life-threatening outcome or death will be reported to the SO and NIA program officer as soon as possible, 
and within 24 hours of study PI knowledge of the event. Other serious study-related adverse events and 
unanticipated adverse events will be reported as soon as possible, and within 48 hours of study PI knowledge 
of the event. The PI, in conjunction with the SO, will review the case and relevant study data to determine 
whether the study should be halted or how it may be altered to promote safety. 
 
Additionally, the SO will meet at least twice per year via telephone or video conferencing to review adverse 
events and their outcomes, and to generate recommendations for study protocol alteration for improved safety 
(or termination of the study, if deemed necessary). 
 
 
SECTION 5: ETHICS AND DISSEMINATION 
 
5.1 Research Ethics Approval & Protocol Amendments 
All procedures detailed above fall within the parameters approved by the University of Michigan institutional 
review board. Any changes to these parameters or procedures will be proposed to and approved by the 
IRB through formal amendments prior to implementation. 
 
5.2 Consent or Assent 
All consent forms and others requiring authorized signatures will be approved by the University of Michigan 
IRB. A study team member will review the consent form for the specific Stage. The team member will pause 
after each section to solicit and answer questions. Comprehension of the procedures, risks, benefits, and other 
aspects of the study will be checked using a decision-making tool (a brief measure asking the participant to 
use his or her own words to review the contents of each section of the consent form before signing). These 
procedures will be followed regardless of whether the consent is completed in person or remotely via electronic 
consent. 
 
5.3 Confidentiality 
Information gathered from individuals contacted for initial screening is entered into a recruitment database file 
that is stored in the shared drive (accessible only to approved lab personnel) and password protected. This 

centralized file will contain only the necessary information for contacting and determining eligibility and interest 
in the study, as well as assigned ID numbers for enrolled participants. For information regarding security and 
confidentiality of data from enrolled participants, see ‘Data Management & Entry’.  
 
Participants will be made aware prior to enrollment in Stage I that they will not receive feedback regarding their 
risk for DAT as part of the Stage I study. As mentioned above, a copy of the consent form is uploaded into the 
participant’s University of Michigan electronic medical record as a ‘Research Document’ to communicate 
current research participation to medical providers. 
 
5.4 Declaration of Interests 
None of the study investigators have any financial or competing interests to declare. 
 
5.5 Access to Data 
Study data will remain housed within the Rahman laboratory at the University of Michigan and will only be 
available to authorized study team members or members of oversight committees (e.g., IRB).  
 
5.6 Ancillary and Post-Trial Care 
As noted above, there are procedures in place to alert the principal investigator and take any needed action to 
deal with serious adverse events or harms that occur during the study session. As stated in the consent form, 
participants are instructed to seek immediate medical attention for any serious adverse events that arise after 
the study session, rather than waiting to contact or hear back from study personnel. Participants are instructed 
that any medical appointments that are attended after the study will be billed through the patient’s regular 
insurance avenues. 
 
As this study is examining a non-clinical sample of healthy older adults, and DAT biomarker risk evaluation is 
not considered part of the standard of care for older adults, there is no obligation to provide a waitlist control or 
delayed access to treatment to individuals assigned to the sham condition. 
 
5.7 Dissemination Policy 
A summary of results from the current study will be uploaded within one year of study completion to 
clinicaltrials.gov. At this time, there are no plans to grant public access to the participant level dataset or 
statistical coding used to analyze data. Findings will be communicated in the form of scientific presentations at 
national meetings and publications in peer-reviewed scientific journals. There are no restrictions on 
publications. Authorship will be based on study contribution, considering efforts towards study design, data 
collection and management, statistical analysis and interpretation, and production of presentations and 
manuscripts.  
 
 
 
 
 

 
 
References 
 
1. Alzheimer’s Association (2018). 2018 Alzheimer’s disease facts and figures. Alzheimer’s Dementia, 14(3), 
367-429. 
2. Chin, AL, Negash, S, & Hamilton, R. (2011). Diversity and disparity in dementia: The impact of ethnoracial 
differences in Alzheimer’s disease. Alzheimer’s Disease Assoc Disord, 25(3), 187-195. 
3. Weimer, DL, & Sager, MA. (2009). Early identification and treatment of Alzheimer’s disease: Social and 
fiscal outcomes. Alzheimer’s Dementia, 5(3), 215-226. 
4. Gilligan, AM et al. (2013). Health disparities in cost of care in patients with Alzheimer’s disease: An 
analysis across 4 state Medicaid populations. American Journal of Alzheimer’s Diseae & Other Dementias, 
28(1), 84-92. 
5. Burns, JM et al. (2017). Safety of disclosing amyloid status in cognitively normal older adults. Alzheimer’s 
Dementia, 13, 1024-1030. 
6. Caselli, RJ et al. (2014). Public perceptions of presymptomatic testing for Alzheimer disease. Mayo Clinic 
Proceedings, 89(10), 1389-1396. 
7. Milne, R, et al. (2018). Perspectives on communicating biomarker-based assessments of Alzheimer’s 
disease to cognitively healthy individuals. Journal of Alzheimer’s Disease, 62, 487-498. 
8. Tang, EYH, et al. (2017). Current developments in dementia risk prediction modeling: An updated 
systematic review. PLoS ONE, 10(9), 1-31. 
9. Jack, CR, et al. (2018). NIA-AA Research Framework: Toward a biological definition of Alzheimer’s 
Disease. Alzheimer’s & Dementia, 14, 535-562. 
10. Edmonds et al. (2015). Subtle cognitive decline and biomarker staging in preclinical Alzheimer’s disease. 
Journal of Alzheimer’s Disease, 47, 231-242. 
11. Gomar, JJ (2011). Utility of combinations of biomarkers, cognitive markers, and risk factors to predict 
conversion from Mild Cognitive Impairment to Alzheimer disease in patients in the Alzheimer’s Disease 
Neuroimaging Initiative. Archives of General Psychiatry, 68(9), 961-969. 
12. Vanderschaeghe, G, et al. (2017). Amnestic MCI patients’ experiences after disclosure of their amyloid 
PET result in a research context. Alzheimer’s Research & Therapy, 9(1), 92. 
13. Mozersky, J, et al. (2018). Comprehension of an elevated amyloid position emission tomography biomarker 
result by cognitively normal older adults. JAMA Neurology, 75, 44-50. 
14. Harkins et al. (2015). Development of a process to disclose amyloid imaging results to cognitively normal 
older adult research participants. Alzheimer’s Research & Therapy, 7, 26. 
15. Lingler, JH, et al. (2016). Development of a standardized approach to disclosing amyloid imaging research 
results in Mild Cognitive Impairment. Journal of Alzheimer’s Disease, 52, 17-24. 
16. Marcheco, B, et al. (2003). Attitudes and knowledge about presymptomatic genetic testing among 
indivdiuals at high risk for familial, early-onset Alzheimer’s disease. Genetic Testing, 7(1), 45-47. 
17. Marcheco, B, et al. (2009). Attitudes and knowledge about genetic testing before and after finding the 
disease-causing mutation among individuals at high-risk for familial, early-onset Alzheimer’s disease. 
Genetic Testing and Molecular Biomarkers, 13(1), 121-125. 
18. Gooblar, J, et al. (2015). Attitudes of research participants and the general public regarding disclosure of 
Alzheimer disease research results. JAMA Neurology, 72(12), 1484-1480. 
19. Rahman-Filipiak, A et al. (2018). Self- and Informant-Reported Memory Complaints: Frequency, Severity, 
and Specificity in Cognitively Intact Individuals and those with Mild Cognitive Impairment and 
Neurodegenerative Dementias. Accepted for publication in the Journal of Alzheimer’s Disease. 
20. Gifford, KA, et al. (2015). Inclusion of an informant yields strong associations between cognitive complaint 
and longitudinal cognitive outcomes in non-demented elders. Journal of Alzheimer’s Disease, 43(1), 121- 
132. 
21. Rattanabannakit, C, et al. (2016). The Cognitive Change Index as a measure of self and informant 
perception of cognitive decline: Relation to neuropsychological tests. Journal of Alzheimer’s Disease, 
51(4), 1145-1155. 
22. Nicholas, CR, et al. (2017). Longitudinal assessment of self- and informant-subjective cognitive complaints 
in a sample of healthy late-middle aged adults enriched with a family history of Alzheimer’s disease. 
Journal of the International Neuropsychological Society, 23, 1-10. 
23. Allen, NL et al. (2014). Biobank participants’ preferences for disclosure of genetic research results: 
Perspectives from the OurGenes, OurHealth, OurCommunity project. Mayo Clinic Proceedings, 89(6), 738- 

746. 
 
24. Roberts, JS et al. (2003). Differences between African Americans and Whites in their perceptions of 
Alzheimer disease. Alzheimer’s Disease and Associated Disorders, 17(1), 19-26. 
25. Robinson, SM, et al. (2014). Preferences of older people for early diagnosis and disclosure of Alzheimer’s 
disease (AD) before and after considering potential risks and benefits. Archives of Gerontology and 
Geriatrics, 59, 607-612. 
26. Rosenstock, IM, et al. (1988). Social learning theory and the Health Belief Model. Health Education 
Quarterly, 15(2), 175-183. 
27. Stites, SD (2018). Cognitively healthy individuals want to know their risk for Alzheimer’s disease: What 
should we do? Journal of Alzheimer’s Disease, 62, 499-502. 
28. Grill, JD, et al. (2017). Communicating mild cognitive impairment diagnoses with and without amyloid 
imaging. Alzheimer’s Research & Therapy, 9, 35. 
29. Rabinovici, GD, et al. (2016). Testing and disclosures related to amyloid imaging and Alzheimer’s disease: 
Common questions and fact sheet summary. Alzheimer’s & Dementia, 12, 510-515. 
30. Guan, Y, et al. (2017). Disclosing genetic risk of Alzheimer’s disease to cognitively impaired participants 
and visit companions: Findings from the REVEAL study. Patient Education & Counseling, 100(5), 927-935. 
31. Cupples, LA, et al. (2004). Estimating risk curves for first-degree relatives of patients with Alzheimer’s 
disease: The REVEAL Study. Genetics in Medicine, 6,192-196. 
32. Yesavage, JA, et al. (1982-1983). Development and validation of a geriatric depression screening scale: a 
preliminary report. Journal of Psychiatric Research, 17(1), 37-49. 
33. Sheikh, JI, et al. (1986). Geriatric Depression Scale (GDS): Recent evidence and development of a shorter 
version. Clinical Gerontologist: The Journal of Aging and Mental Health, 5(1-2), 165-173. 
34. Beck, AT, et al. (1988) An inventory for measuring clinical anxiety: Psychometric properties. Journal of 
Consulting and Clinical Psychology, 56, 893-897. 
35. Wetherell, JL, & Arean, PA, (1997). Psychometric evaluation of the Beck Anxiety Inventory with older 
medical patients. Psychological Assessment, 9(2), 136-144. 
36. Horowitz, M, et al. (1979), Impact of event scale: A measure of subjective distress. Psychosomatic 
Medicine, 41, 209-218. 
37. Reichelt, JG, et al. (1999). Uptake of genetic testing and pre-test levels of mental distress in Norwegian 
families with known BRCA1 mutations. Disease Markers, 15, 139-143. 
38. Wood, M, et al. (2000). Impact of BRCA1 testing on women with cancer: a pilot study. Genetic Testing, 
4(3), 265-272. 
39. Cella, D, et al. (2002). A brief assessment of concerns associated with genetic testing for cancer: The 
Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. Health Psychology, 21(6), 
564-72. 
 
 
 
 

Appendix A. Safety Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*Note: For virtual visits, study team members will verify participants’/co-participants’ call-back 
number and address of their current location at the outset of each session. 
Potential Suicidal Ideation indicated by: 
• 
Negative answer to GDS #11, ‘Do you think it is wonderful to be alive now?’ 
• 
Score > 5 on GDS-15 and/or Score > 16 on BAI 
• 
Participant direct or indirect reference to suicidal ideation, intention, plan, or preparatory 
behaviors (e.g., giving away personal items, stock-piling medications) 
• 
Informant concerns about changes in the participant’s thoughts/speech/ actions consistent with 
depression 
Risk Assessment & Safety Planning 
1. Principal Investigator completes assessment of: 
a. Current/past suicidal thoughts 
b. Current/past suicidal intention or plans 
c. Current/past preparatory behaviors 
d. Current/past suicidal actions or attempts 
e. Access to means 
f. Current supports/barriers to carrying out suicidal thoughts/plans 
g. Current reasons for living 
h. Current/past treatment for psychiatric issues, including contact information 
if available 
2. If needed, consultation with Co-Investigators 
3. Study team determines whether active threat to self (need for hospitalization). 
 
No Active Threat 
1. Provide resources: 
a. Depression brochure  
b. Ann Arbor -  Mental 
Health Resources and 
Washtenaw County 
Senior Resources lists    
                      (OR)   
Detroit -  Community 
Resources for Seniors 
list 
2. Complete Safety Plan with 
patient 
3. Encourage participant to 
follow up with own health 
care provider. 
Active Threat 
In-Person Visit Protocol: 
1. Ann Arbor 
a. Call UM Psychiatric Emergency Services: 734-936-5900 
b. Call Huron Valley Ambulance for transport: 734-994-4111 
2. Detroit 
a. Call 9-1-1 
3. Clinician remains with participant until they leave in ambulance. 
 
Virtual Visit Protocol: 
1. Confirm participant phone #/current location. 
2. If participant has friend/family present to safely transport to 
emergency department, proceed. 
3. If no friend/family member present, stay on call with participant & 
call UM PES Care Manager: 
a. 8am-5pm: Page #34832 with your location, means of 
contacting you (phone, IM) 
b. After-hours: Call local police or SW at 734-936-5900 (will 
assist with contacting police).