Stimulation to Improve Memory: PET Education & Disclosure
Phase: NA
Conditions: Mild Cognitive Impairment, Dementia; Alzheimer's Type (Etiology)
Sponsor: University of Michigan

Study Title:  Stimulation to Improve Memory: Alzheimer's Disease Biomarker Education, Decision-
Making, & Disclosure
NCT:  NCT04818255
Protocol Version IRB Approval Date: 6/23/2025

STIM+ Bioethics Supplement Study Protocol 
PARENT STUDY TITLE: 
Treating Mild Cognitive Impairment with Transcranial Direct Current 
Stimulation 
PARENT STUDY SHORT TITLE: Stimulation to Improve Memory (STIM) 
FULL STUDY TITLE: 
Stimulation to Improve Memory: Alzheimer’s Disease Biomarker Education, 
Decision-Making, & Disclosure 
SHORT STUDY TITLE: 
Stimulation to Improve Memory: PET Disclosure (STIM+) 
Protocol Amendment Number: 01 
Original 
Authors: ARF 
Issue Date: 01 September 2020 
Amendment 
Authors: ARF 
Issue Date: 7 December 2021 
Amendment 
Authors: ARF, ML 
Issue Date: 22 March 2022 
Amendment 
Authors: ARF, ML 
Issue Date: 06 December 2022 
Secondary Registry Numbers: 
 Parent Grant #: R01AG058724 
 Parent IRB: UMIRB: HUM00146180 
 Study IRB: HUM00188109 
 NCT: TBD 
Sources of Support:   
NIH/NIA 3R01AG058724-03S1 
Contact for Public/Scientific Queries: 
ARF [rahmanam@med.umich.edu] 
Trial Sponsor: 
NIH/NIA 
Address: 
Neuropsychology Section, Department of Psychiatry 
Arbor Lakes 1, 4251 Plymouth Road, Suite 2400 
 
Ann Arbor, MI 48105 
(734) 936-3180
Public Title: 
Alzheimer’s Disease Biomarker Education, Decision-Making, & Disclosure 
Countries of Recruitment: 
United States of America 
Problem(s) Studied:  
 Alzheimer’s Disease; Positron emission tomography-based amyloid and tau 
disclosure  
Intervention: 
Education: Behavioral Intervention to maximize comprehension and facilitate 
informed decision-making 
Disclosure: Behavioral Intervention to maximize comprehension and facilitate 
positive and adaptive psychological and behavioral reactions 

Key Inclusion Criteria:  
Education: Enrollment and completion of all study-related activities in one of the 
parent studies; complete and interpretable PET amyloid data (tau data 
recommended but not required); for participants with Dementia – Alzheimer’s 
Type (DAT), the presence of a co-participant is required; for participants with Mild 
Cognitive Impairment (MCI), co-participants are strongly encouraged unless the 
participant has a legally authorized representative or power or attorney for 
medical/research decisions; for those completing virtual visits: laptop, desktop, or 
tablet (>9.7” diagonal width) and stable, secure internet connection required; 
prior established relationship with a PCP, geriatrician, or mental health 
professional. 
 
Disclosure: Same as Education portion, plus requirement for demonstrated intact 
decisional capacity for PET amyloid and tau disclosure 
 
Key Exclusion Criteria: 
Education: Baseline severe or untreated active depression/anxiety or other 
severe psychological diagnosis, other significant neurological insult or diagnosis, 
severe and untreated substance use disorder, severe hearing or vision 
impairment 
 
Disclosure: lack of participant/designated other decisional capacity 
 
 
Study Type:   
 
Interventional, single-group design 
 
Primary purpose:  
 
Education: Complete educational presentation about Alzheimer’s Disease (AD),  
Dementia-Alzheimer’s Type (DAT), amyloid and tau PET imaging as it relates to 
AD diagnosis, and risks and benefits of learning this personal health information; 
measure comprehension and decisional capacity for PET disclosure among 
symptomatic participants and/or their co-participants. 
 
Disclosure: Complete personalized PET amyloid and tau disclosure protocols 
with participants and family members of diverse racial-ethnic backgrounds; 
investigate initial outcomes including comprehension/recall of results, positive 
and negative psychological reactions, perceived disease stigma, and future time 
perspective immediately following disclosure, within 1-week post-disclosure, and 
at 6-weeks post-disclosure 
 
Phase:  
 
 
I/II (Part II: Disclosure) 
 
Date of First Enrollment: 
10/1/2020 
 
 
 
 
 
Target Sample Size:  
100 
 
 
 
 
 
Recruitment Status:  
Currently recruiting 
 
Primary Outcomes: 
Part I Education:  
(a) Interest in receiving PET amyloid and tau feedback prior to and 
 
 
 
 
 
 
after education 
 
 
 
 
 
 
(b) participant decision-making capacity for disclosure 
 
 
 
 
Part II Disclosure: 
(a) Comprehension/recall of personal risk information 
(b) Positive and Negative Affect Scale 
 
 
 
 
 
 
(c) Impact of Genetic Testing – Alzheimer’s Disease (Revised) 
 
 
 
 
 
 
(d) Stigma Scale for Chronic Illness 
 
 
 
 
 
 
(e) Self-Efficacy for Managing Chronic Disease 
 
 
 
 
 
 
(f) Future Time Perspectives Scale 
 
 
 
 
 
 
 

SECTION 1: Roles & Responsibilities - Contributorship 
 
Benjamin Hampstead, Ph.D., ABPP-CN (BMH) – Principal 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 of ARF 
Preparation of manuscripts 
 
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 
 
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 of ARF 
 
Marie Milliken, MSW (MM) – Research Associate/Study Social Worker 
 
 
 
 
Data collection 
 
 
 
 
Participant support 
 
Sara J. Feldman, MPH, Doctoral Candidate – (SJF) – Research Associate 
 
Affiliations: 
 
University of Michigan, School of Public Health  
 
Contact: 
 
sarajph@umich.edu 
 
Roles & Responsibilities: 
Preparation of protocol and revisions 
 
 
 
 
Data collection 
 
 
 
 
Data entry, verification 
 
 
 
 
Statistical Analyses 
 
 
 
 
Preparation of study reports 
 
 
 
 
Preparation of manuscripts 
 
Mary Lesniak, B.A. (ML) – Research Associate 
 
Affiliations: 
 
University of Michigan, Department of Psychiatry 
 
Contact: 
 
marles@umich.edu 
 
Roles & Responsibilities: 
Preparation of protocol and revisions 
 
 
 
 
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 
 
BMH/ARF conceived of the study, developed and refined the study protocol, and are responsible for study 
implementation, including data collection, entry, and management. JSR will oversee implementation of the 
education and disclosure protocols. MM will be responsible for outcome data collection and will be responsible 
for providing support and resources for participants and their families during, between, and after study 
sessions. SJF will be responsible for assisting with revisions to protocol as needed, data collection and data 
entry. ML will be primarily responsible with administrative aspects of the study, including screening and 
scheduling of participants and co-participants for all sessions, data collection and data entry, and preliminary 
statistical analyses. BMH, ARF and SJF will complete statistical analysis, prepare manuscripts and 
presentations, with editing input from other collaborators. 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 a bioethics supplement award granted to BMH from the NIH/NIA, to extend the 
work of the parent study. 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 
 
 The central goal of this supplement is to begin addressing a vital “communication” gap that occurs between 
the collection of biomarker data related to Alzheimer’s disease (AD) and related dementias and the absence of 
methods to disclose this information to patients and their care partners, as applicable. The longstanding 
justification that disclosure is not appropriate or necessary given the lack of pharmacologic treatment options is 
now thoroughly undermined by evidence that lifestyle1-2 and other non-pharmacologic interventions3-4 may alter 
clinical progression. Regardless of whether asymptomatic5-6 or symptomatic7-10, patients almost universally 
demonstrate strong interest in knowing their biomarker-based risk information, and seek to use this information 
to plan health behavior or lifestyle change5,11-15. The combination of this literature and our preliminary data 
below demonstrate a clear benefit of, and participant interest in, knowing biomarker status. Thus, we directly 
address the first ethical dilemma that potentially impactful information is being intentionally withheld from our 
participants.  
The current project leverages a robust recruitment and characterization pipeline formed through the 
Stimulation to Improve Memory study (STIM; R01AG058724) as well as empirically-derived methods from the 
Sharing Alzheimer’s Risk Estimates (SHARE; R03AG063222-01) study. STIM will ultimately enroll up to 240 
individuals with mild cognitive impairment (MCI) and dementia of the Alzheimer’s type (DAT) to evaluate the 
dose-response relationship associated with transcranial direct current stimulation. Each participant receives 
both amyloid and tau positron emission tomography (PET), which are used as participant-specific factors that 
may affect tDCS efficacy. We did not include biomarker disclosure in STIM because it was outside of the scope 
of the intervention-related focus. Moreover, it was not clear at the time of the initial submission whether 
participants would be interested in receiving feedback about their biomarker status. Approximately 3 recruiting 
quarters into the study, there is now substantial evidence that participants want the information. Thus, the 
STIM infrastructure provides an ideal testbed for developing/refining feedback methods for cognitively 
symptomatic individuals. To improve enrollment and in response to overwhelming interest in biomarker 
disclosure, we are also opening up this study to participants from other studies co-enrolling through the 
Michigan Alzheimer’s Disease Research Center that include PET amyloid (and tau, if available) imaging, as 
long as they meet other criteria detailed above. These additional ‘parent’ studies include the Driving and 
Physiological Responses (DAPR; HUM00183327), Brain-Behavior Characterization (BBC; HUM00200763) and 
Dementia in African American Population Phenotyping from Potential Elevated Risk (DAPPER; 
HUM00152159) studies. 
We have preliminary data, acquired from Co-I Rahman-Filipiak’s R03-funded study investigating older 
participants’ interest in biomarker-based feedback, that shows a clear majority of participants have moderate-
strong interest in learning their amyloid and tau status (Table 1). In fact, these initial data indicate that 
participants have equal if not stronger interest in biomarker disclosure as compared to other sources of health 
information (Table 1). Furthermore, 100% of participants interviewed to date would elect to learn their 
Alzheimer’s-related biomarker status if it were available, regardless of race, gender, or whether they were 
cognitively symptomatic or healthy. These findings mirror preliminary data gathered from those currently 
Table 1. Preliminary Biomarker Disclosure Interest Data 
Interest Level
Clinical Information
Structural 
Neuroimaging
APO-E Genotype
Amyloid/Tau Status
No Interest
0 (0%)
0 (0%)
0 (0%)
0 (0%)
Very Minimal Interest
0 (0%)
0 (0%)
0 (0%)
0 (0%)
Neutral Interest
0 (0%)
1 (6%)
1 (6%)
0 (0%)
Moderate Interest
1 (6%)
1 (6%)
1 (6%)
2 (12%)
Strong Interest
15 (94%)
14 (88%)
14 (88%)
14 (88%)
No
0 (0%)
0 (0%)
0 (0%)
0 (0%)
Yes
16 (100%)
16 (100%)
16 (100%)
16 (100%)
Would you engage in elective disclosure about your risk for AD based on these variables?

enrolled in STIM (in which the study team does NOT mention disclosure options): of the 31 enrolled 
participants, 42% spontaneously requested feedback about their amyloid and tau imaging, and 23% mentioned 
significant disappointment or distress that the current protocol does not allow for disclosure of this information. 
Additionally, two participants were previously interested in the study but declined to enroll after learning that 
feedback was not currently provided.  
The ethical principles of patient autonomy and beneficence must be carefully weighed against non-maleficence 
and protection of the potentially vulnerable population of cognitively impaired older adults16. AD Biomarker 
disclosure can occur only if patients (or their designated signors) fully understand the information to be shared, 
and appreciate the risks and benefits of knowing this information. Preliminary data from Co-I Rahman-FIlipiak’s 
R03 demonstrate that participants request risk disclosure for a variety of perceived benefits; however, 88% 
endorse having ‘no concerns’ about risks of amyloid or tau disclosure (Figure 1). These data, while likely 
reflective of a strong desire for disclosure in the larger population, indicate a second ethical dilemma: 
whether to share information with symptomatic participants who may have impaired decision-making capacity 
to engage in amyloid/tau disclosure. 
Finally, results of the prior literature suggest that disclosure of biomarker information related to AD is both safe 
and well-tolerated among cognitively healthy participants. Studies examining post-disclosure psychological 
reactions are very limited in individuals with mild cognitive impairment, and non-existent for individuals already 
diagnosed with DAT. Further, no prior study has examined the impact of symptomatic patients’ biomarker 
information on care partners who are likely impacted by their partners’ health information related to AD and 
who are also likely to have a pivotal role in their partners’ health care and future care in the event of worsening 
cognitive impairment. Additionally, prior studies have exclusively considered the negative psychological effects 
of risk disclosure, rather than the full range of emotional reactions and the empowering results that may follow 
disclosure. Therefore, we address this third ethical dilemma by evaluating both positive (e.g., relief, 
happiness, satisfaction, empowerment) and negative (e.g., depression, anxiety, anger, distress) effects of 
biomarker disclosure on symptomatic participants and their co-participants (e.g., care partners). 
 
SECTION 2.2: Objectives & Hypotheses of the study 
 
Preliminary data gathered from the Stimulation to Improve Memory (STIM) study and an associated research 
project have highlighted several unforeseen but compelling needs in regards to sharing of Alzheimer’s disease 
(AD) biomarker information with research participants and patients alike. The proposed ethics supplement 
addresses three of these needs, each of which represents an ethical dilemma underlying the communication 
gap in AD biomarker research: 1) the withholding of biomarker information from interested participants, 2) the 
unknown ability of cognitively symptomatic patients to appreciate risks and benefits of biomarker disclosure, 
and 3) the psychological ramifications of biomarker disclosure in cognitively impaired patients. We will leverage 
STIM infrastructure to systematically address these questions through three specific aims: 
Figure 1. Participants’ perceptions of primary benefits and risks of AD biomarker disclosure 
(data from Co-I Rahman-Filipiak’s R03) 

Aim 1 investigates interest in, and follow through with, amyloid and tau status disclosure in individuals 
diagnosed with MCI and DAT. At the time of study enrollment, we will offer all parent study participants the 
opportunity to learn their amyloid and tau status upon completion of parent study procedures; recording 
preference as appropriate. We will then examine follow through rates (i.e., interested vs. completed 
disclosures) thereby extending the literature. We predict an equally high interest in, and completion of, 
disclosure regardless of diagnosis. 
Aim 2 examines whether cognitively symptomatic participants demonstrate decision-making capacity 
as it relates to biomarker disclosure. The question of whether research participants can demonstrate 
decision-making capacity for biomarker disclosure has, to our knowledge, never been addressed in cognitively 
symptomatic individuals. Thus, we fill a critical void by evaluating whether such “patients” adequately 
demonstrate the fundamental elements of decision-making capacity (understanding, appreciation, rationale, 
communication)17. Prior to disclosure, we will use a standardized, clinician-rated measure to evaluate capacity. 
We predict a main effect of diagnosis where DAT participants demonstrate poorer decisional capacity relative 
to MCI. Importantly, we overcome this predicted difference by providing disclosure to either the impaired 
participant’s legally authorized representative or their healthcare provider. In this way, we ensure the desired 
information is relayed to each interested participant while still achieving the study aims.  
Aim 3 will determine immediate and prolonged psychological reactions to biomarker disclosure among 
participants with MCI and DAT and their respective co-participants (e.g., care partners). We will assess 
changes in psychological status (both positive and negative) at two time points following disclosure relative to 
baseline. While one could predict changes in either direction, the above noted paucity of data in this area 
undermine the validity of such predictions. Thus, this aim is more descriptive in nature and provides critical 
information about cognitively symptomatic participants’ response to biomarker disclosure that will guide future 
research and translational efforts. 
 
Aim 4 examines the impact of biomarker disclosure on co-participants as it relates to caregiving 
readiness and self-efficacy. We will assess changes in perceived readiness to provide care (to the 
participant) and caregiving self-efficacy at two time points following disclosure relative to baseline among co-
participants who are either currently providing care to participants with MCI/DAT or who will hypothetically take 
on the caregiving role should the need arise. We predict that caregiving preparedness will be associated with 
the participant’s disclosed amyloid/tau result; specifically, an ‘elevated’ biomarker result is hypothesized to be 
associated with greater caregiving preparedness. Conversely, it is hypothesized that co-participants will have 
lower perceived readiness for caregiving if the participant’s amyloid/tau result is ‘not elevated.’ 
 
 
SECTION 2.3: Trial Design 
The Education portion of the study is considered a Phase I/II Behavioral Intervention clinical trial without 
randomization. The Disclosure portion of the study is considered a Phase I/II Behavioral Intervention clinical 
trial without randomization, with the disclosure feedback serving as the intervention. The study will use a 
single-group design. All 100 participants (and any co-participants attending the first session) will complete the 
educational presentation and undergo an assessment of comprehension and decisional capacity. Those 
participants or dyads who meet criteria and demonstrate intact decisional capacity will be offered feedback 
about the participant’s PET amyloid and tau results. Outcomes will be measured immediately following 
feedback, within one week of disclosure, and at six-weeks post-disclosure. For more information regarding 
design, see Methods section. 
 
SECTION 3: METHODS 
 
SECTION 3.1 Participants: Inclusion & Exclusion Criteria 
 
The proposed supplement directly extends STIM study infrastructure (Figure 2). All participants will complete 
parent study procedures (including amyloid and tau PET) before engaging in the activities of this supplement. 

Participants: All participants (i.e., those with MCI and DAT) enrolled in STIM (HUM00146180) will express 
their interest in biomarker disclosure (Aim 1); however, only those who actually complete PET imaging will be 
eligible to receive this information (otherwise there is no information to disclose). Specific inclusion and 
exclusion criteria for STIM are included below: 
 
STIM Inclusion Criteria: 
(1) Diagnosis of MCI or DAT 
 
 
 
 
(2) Age 55 and older 
 
 
 
 
(3) MRI-compatible 
 
 
 
 
(4) Stable on medications for 4 weeks prior to study enrollment 
 
STIM Exclusion Criteria: 
(1) Other neurologic disease (e.g., epilepsy, stroke, traumatic brain injury) 
 
 
 
 
(2) Psychiatric conditions (e.g., moderate-severe depression, bipolar disorder,  
schizophrenia) 
 
 
 
 
(3) Sensory impairments that limit the ability to take part in the study 
 
 
 
 
(4) A significant history of, or current alcohol or drug abuse/dependence 
 
 
 
 
(5) Are left-handed with right hemisphere language lateralization 
 
We will additionally invite participants who have completed PET amyloid (and ideally tau) scans through other 
MADRC-co-enrolled studies (DAPR [HUM00183327], BBC [HUM00200763] and DAPPER [HUM00152159]) to 
take part in this bioethics supplement, provided they have a diagnosis of MCI or DAT and meet with the 
additional study-specific criteria below. 
 
Additional inclusion/exclusion criteria for the Education portion of the study are included below: 
 
Part I Education Inclusion Criteria:  
(1) Complete and interpretable PET amyloid and tau imaging 
(2) For those completing virtual sessions: Laptop, desktop, or 
tablet with 9/7” diagonal diameter and stable, secure internet 
connection 
(3) Established relationship with a primary care provider, 
geriatrician, and/or mental health professional  
(4) Co-Participant – required for individuals with DAT; strongly  
encouraged for participants with MCI 
 
Part I Education Exclusion Criteria: 
(1) Baseline active depression or anxiety or clinically elevated 
scores on Geriatric Depression Scale – 15 (GDS-15)25-26 or Beck 
Anxiety Inventory (BAI)27-28 
 
(2) History of significant neurological disease  
 
(3) Current severe or untreated substance use disorder 
 
Part II Disclosure Inclusion Criteria:  
(1) Demonstrated intact decisional capacity for amyloid and tau 
PET disclosure 
 
Part II Disclosure Exclusion Criteria: 
No additional criteria 
 
For the proposed study, we will offer all of the participants who have completed all parent study procedures up 
to and during this one-year supplement funding period (we estimate up to 100 individuals) the opportunity to 
enroll in the supplement-related procedures. 
 
Co-Participants: Co-participants are required for all participants with a diagnosis of DAT, given the likelihood 
that participants may have impaired decision-making capacity and/or need additional support following 
disclosure. Co-participants are also strongly recommended, though not required, for participants with a 
diagnosis of MCI except in the event a participant with MCI demonstrates impaired decision-making capacity, 
thus requiring a co-participant. Co-participants are defined as (a) those who are currently serving as a 

caregiver to the participant, or would hypothetically serve in this role should the need arise; (b) individuals who 
know the participant well, as demonstrated by a relationship lasting at least five years, and contact (any 
modality) at least once per week. Co-participants must also be age 18 years or older, English-speaking, 
cognitively healthy, and without current severe or untreated depression and/or anxiety. 
 
Of note, if participants have a dedicated legally authorized representative (LAR) or durable power of attorney 
(DPOA) for medical and/or research decisions, this individual must serve as the co-participant in order for the 
participant to take part in the study. Documentation of this legal designation must be provided. 
 
SECTION 3.2 Recruitment Strategy 
 
Participants for Part I: Education will be recruited from parent studies via invitation only. The study team will 
review participants who completed the parent study, screen these cases for any interim changes that might 
impact eligibility of the participant (or co-participant, if there is one), and contact dyads to determine interest in 
engaging in STIM+ Education. 
 
All participants who demonstrate decisional capacity for disclosure (or have a co-participant or LAR/DPOA who 
demonstrate decisional capacity for disclosure) will be invited to take part in Part II: Disclosure by study team 
invitation. 
 
SECTION 3.3 Procedures 
In light of the 2020 global COVID-19 pandemic, we have adapted our procedures to include the option for 
virtual, video-conferencing sessions, to reduce the risk of exposure for our vulnerable study population. The 
virtual option will be the default offered to all participants. 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 materials for Part I Education and Part II Disclosure 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 of their appointment(s). Those enrolled in 
the study will be sent private links to engage in a secure video conference session through the Zoom for Health 
application, a free, HIPAA-compliant service through the University of Michigan. 
 
Participants who do not have access to or comfort with the above technology will be offered the opportunity to 
take part in an in-person visit following strict Covid-19 safety precautions that include preliminary, day-before, 
and day-of screening for symptoms using the University of Michigan ResponsiBLUE screening, PPE for 
participants and study team members, distancing while in the laboratory, and rigorous cleaning and contact 
tracing procedures. In-person visits and associated procedures will follow recommendations from the Office of 
Research. 
 
3.3.1 Part I Education Procedures 
At the time of enrollment in the parent study, participants will be asked whether they would be interested in 
receiving feedback about amyloid and tau positivity or negativity from their PET scans (Aim 1). Following 
parent study completion, up to 100 interested participants and their co-participants (if designated) will be 
approached for the Education Session. A summary of Part I procedures is included in Table 2. 
Preliminary Screening of STIM Participants: 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 
access the participant’s prior parent study involvement to determine whether they have adequate 
information for risk disclosure. If the participant meets these criteria, the study team will send an email 
introducing the study (see ‘STIM+ Education Script’) and begin contacting the participant via phone 
(see ‘STIM+ Part I Oral Script’).  
 
Preliminary Screening of Participants from Other Parent Studies: For studies within the Research 
Program on Cognition and Neuromodulation Based Interventions (BBC), the study team (BMH, ARF, 
ML) are all part of the larger program and approved study team members on the IRB. For additional 

studies [(DAPR (HUM00183327) and DAPPER (HUM00152159)], we will utilize the current MADRC 
protocol for sharing of eligible participants through the MADRC Data Core.  
 
Virtual Informed Consent: The informed consent document will be emailed to participants and  
co-participants at the time of scheduling (or earlier by request), 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 or LARs/DPOAs will review the STIM+ Disclosure Packet Request Form to 
determine whether they would like to receive a written copy of their results post-disclosure, and whether 
they’d like to receive them via US mail system or office pickup. After reviewing the forms, participants 
will be asked to provide electronic signatures on each form. These 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 forms, with all signatures, will be emailed to the participant/co-participant or made available through 
SignNow.  
 
In-Person Consent: Participants completing in-person sessions will be encouraged to follow the above 
procedures to complete the consent paperwork via phone or Zoom prior to their in-person session, 
even if they choose to sign the consent in person. This will allow the study team to assess consent 
decisional capacity and walk through the consent form thoroughly before the participant comes into the 
lab (which may be more burdensome). 
 
Additional Screening & Scheduling: Following receipt of the signed informed consent documents, both  
the participant and any co-participants 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 clinical cutoffs (GDS ≥ 9; BAI ≥ 16) 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 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 subjects has been 
completed, the study team will schedule the Education session. 
 
Education & Decision-Making Assessment Session: Participants (and co-participants, as applicable) 
will take part in a single 90-minute session via video conference (see Table 2). 
 
1. Participants and co participants will complete a baseline assessment of their knowledge 
and understanding of AD biomarker testing procedures, results, risks, and benefits 
(Disclosure Decision-Making Assessment Tool; see below). Immediately following this 
assessment, participants will be shown an interactive educational presentation reviewing. 
AD, DAT, available treatments, and the risks, benefits, and limitations of PET Aβ and tau 
disclosure in regard to assessing AD pathology and risk for DAT development. 
 
2. Educational Module – The psychoeducation module will consist of a brief, instructor-led Power-point 
presentation. This didactic will cover the following topics: (a) definition of Alzheimer’s disease and 
dementia due to Alzheimer’s; (b) the role of amyloid and tau in Alzheimer’s disease; (c) how 
amyloid and tau were measured in the parent study (i.e., PET imaging, what ‘positivity’ means in 
this context); (d) limitations of these measurements; (e) basic AD risk associated with amyloid and 
tau; (f) potential benefits of knowing one’s biomarker status; (g) potential risks of knowing one’s 
biomarker status. This module will include multiple opportunities for the participants and their loved 

ones to ask questions. These materials were adapted from existing materials currently used in the 
Risk Evaluation and Education for Alzheimer’s Disease (REVEAL) study, of which Co-I Roberts is 
Co-PI, as well as Co-I Rahman-Filipiak’s R03. Participants will also be provided with written 
materials summarizing this information. Materials will be written in lay language to accommodate all 
participants in the study.  
 
3. Disclosure Preferences & Decision-Making Capacity Assessment – The educational module 
contains several ‘checks for understanding’ that parallel the questions on the Disclosure Decision-
Making Assessment Tool (DDMAT) after each section to determine whether the participant fully 
demonstrates decision-making capacity for risk disclosure (Aim 2). Specifically, to demonstrate 
understanding of the decision, participants or their designated DPOA/LAR will be asked to describe, 
in their own words, the purpose and procedures involved in personal biomarker disclosure. To 
demonstrate appreciation of the decision, they will be asked to describe possible risks and benefits 
of personal biomarker disclosure. To evaluate reasoning, they will be asked to discuss their 
personal weighing of these risks and benefits, and alternatives to participation. Finally, they will be 
asked to communicate, either aloud or in writing, whether they would like to move forward with 
biomarker disclosure. Participants’ responses will be recorded and subsequently transcribed for 
later evaluation of themes and foci. After each question, the clinician will evaluate the response for 
completion, ensuring it complies with necessary standards. If respondents provide an erroneous or 
incomplete response (e.g., acknowledging only one of several risks), the examiner will return to the 
section of the Education module reviewing the missed information, present it again, and then repeat 
the DDMAT question. If respondents are not able to provide a full, accurate response after such 
review, the question will be considered ‘failed’. To address Aim 2, we will record not only who was 
able versus unable to demonstrate disclosure decision-making capacity, but also the specific 
element(s) of decisional capacity that were failed. Such information provides important information 
about how to better structure content so as to maximize comprehension in future efforts. 
 
If the participant does not demonstrate disclosure decision-making capacity and does not have 
a co-participant or LAR/DPOA, the participant’s involvement in the study will be complete after 
this session, and they will not be invited to take part in the Part II Disclosure portion. 
 
If the participant has a LAR/DPOA co-participant, that individual must demonstrate decision-
making capacity for the participant to receive risk disclosure and agree with this decision. 
Participant decision-making capacity will still be assessed. Regardless of whether the 
LAR/DPOA 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/DPOA 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. 
 
If the participant brings a co-participant who is not the designated LAR/DPOA, the participant 
may allow that individual to make the decision regarding PET disclosure for them. If this option 
is selected, the co-participant will undergo disclosure decision-making capacity assessment. 
Participant decision-making capacity will still be assessed. Regardless of whether the co-
participant 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 co-participant 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. 
 
4. Baseline Outcome Measurement (for Part II): In order to gather baseline measurements of the 
constructs of interest for Part II of the study, all participants in Part I will complete the five outcome 
measures listed in Section 3.4. 
Table 2. Proposed Components of Part I Education 
1. Consent for Education (may be completed pre-session; separate) 

 
 
 
 
 
 
 
 
 
 
 
 
 
Both participants and their respective co-participants who complete the Education session will each be 
compensated with $10 paid via check after the session. 
 
3.3.2 Disclosure Procedures  
 
Following the Part I Education session, participants/co-participants who are deemed eligible will be invited to 
take part in a 90-minute virtual Part II Disclosure session. Study team members will contact the participant or 
dyad via phone to introduce the study (see ‘STIM+ Disclosure Oral Script’). Disclosure procedures are 
summarized in Table 3. 
 
1. Consent – Interested participants will undergo a separate consent procedure for Disclosure, given the 
differing level of risk in this portion as compared to the Education portion. Consent will be completed 
virtually following the same procedures as detailed above in the Education Procedures section. 
 
2. PET Disclosure: All parent studies utilize the expertise and methods of Dr. Robert Koeppe (head of 
PET imaging at University of Michigan) for PET analysis; this will ensure consistency across methods 
and interpretive messaging regardless of the parent study. Each participant’s PET imaging will be 
reviewed by Dr. Robert Koeppe, who will provide both region-specific and total standardized uptake 
value ratio (SUVr) calculations of amyloid and tau burden and determinations of whether these ratios 
surpass normatively-referenced thresholds to indicate amyloid or tau positivity. We will share only 
positive vs. negative status and simplified qualitative risk estimates (e.g. positivity = ‘increased 
risk/likelihood of Alzheimer’s etiology’), given the current lack of validated quantitative models of AD risk 
based on amyloid and tau. The study team have developed a flexible disclosure protocol that provides 
written and graphic representations of the participant’s amyloid results (see ‘STIM+ Disclosure Slides’). 
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 PET 
results (to ensure that appropriate recommendations and resources are given). PET results will be 
provided as a qualitative interpretation (i.e., Elevated vs. Not Elevated) of the presence or absence of 
significant burden for either of the abnormal proteins. Disclosure will also involve discussion that 
elevation on either/both proteins may indicate underlying AD pathology that may explain their current 
cognitive/behavioral symptoms. 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. 
 
3. Outcome Assessment: Immediately following risk disclosure, the participant and co-participant (if 
present) will complete outcome measures with a study team member and, as needed, a brief 
psychological risk assessment with a clinical psychologist and/or social worker. Both parties will receive 
a packet of personalized resources or supports from the region- and service-specific list developed in 
ARF’s prior work, through the Michigan Alzheimer’s Disease Research Center, or through the NIA. 
2. Education Presentation (participant with co-participant) 
3. Participant Decision-Making Capacity Assessment (separate) 
4. Co-Participant or LAR/DPOA Decision-Making Capacity Assessment (separate) 
5. Participant& Co-Participant Baseline Outcome Measurement (separate) 
6. Post-Session study team review of responses to determine Disclosure eligibility 

Participants 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/DPOA. No 
results will be uploaded in the participant’s medical record; however, they are welcome to share the 
results with their medical providers independently. If the participant or LAR/DPOA wishes the study 
team to contact the participant’s medical providers to discuss any of the findings, an Authorization to 
Release Information will be filled out and signed by the participant/LAR/DPOA, specifying exactly which 
information should be shared or discussed, in what format, to whom, and for how long.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participants who complete the Disclosure session will be compensated with $20 paid via check after the 
session. Likewise, co-participants who complete the Disclosure session will also be compensated with $20 
paid via check following the session. 
 
3.3.3. Follow-Up Procedures:  
 
1. Formal Follow-Up Sessions: Within one week of disclosure, the social work team member will contact 
all participants and co-participants (as applicable) to assess psychological reactions to, and coping 
with, biomarker disclosure (Aim 3). These measures will be repeated at 6-weeks post-disclosure. These 
measures will be conducted via phone or video conference based on participant preference.  
2. Informal Between-Session Follow-Up: Participants and DPOAs/LARs will be provided with contact 
information for the social worker and clinical psychologists at the time of disclosure; we will also track 
any additional requests for information, support, or resources between assessment sessions and 
provide such information as appropriate. 
 
Participants and co-participants will each be compensated with $10 per follow-up session completed, paid via 
check after the session. 
 
Table 3. Proposed Order & Components of Disclosure Sessions 
1. Consent for Disclosure (may be completed pre-session) 
2. Personal Risk Disclosure (participant and co-participant) 
3. Recommendations (participant and co-participant) 
4. Participant & Caregiver Resources (participant and co-participant) 
5. Risk Assessment & Follow-Up (as needed; separate)) 
6. Outcomes Assessment (separate) 

 
 
3.4 OUTCOMES  
 
In addition to measuring preliminary interest in PET disclosure after STIM activities (Aim 1, Primary 
Outcome 1) and Disclosure Decision-Making Capacity (overall and by component; Aim 2, Primary 
Outcome 2), we will collect the following outcome measures post-disclosure for participants who complete this 
step (Aim 3). These measures will be completed over the phone or via virtual visit to allow for maximum 
flexibility. Of note, we will also administer the GDS-15 and BAI at each time point for the purpose of safety 
monitoring (see DSMP); these are not considered primary outcomes. A summary of the outcome measure 
respondents and timeline is provided in Table 4. 
 
Primary Outcome 3.1 - Comprehension & Recall: The Personal Information and Meaning of 
Information accuracy scores will be totaled for all participants and co-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 3.2 - Positive and Negative Affective Scale – Short Form (PANAS-SF18): This 
20-item scale asks respondents to rate the extent to which they are experiencing positive (e.g., excited, 
inspired) and negative (e.g., distressed, ashamed) emotions on a Likert-style scale ranging from ‘1 = Very 
Slightly or Not at All’ to ‘5=Extremely.’ The two subscale scores range from 10-50, with higher scores indicating 
higher positive or negative emotions, respectively. The PANAS has demonstrated strong psychometric 
properties for assessing emotions in older adults19. This measure will be administered to both participants and 
co-participants. 
 
Primary Outcome 3.3 - Impact of Neuroimaging in Alzheimer’s Disease (INI-AD): This measure 
assesses both positive and distressing reactions to disclosure of PET amyloid and tau results. The measure is 
adapted from the original Impact of Genetic Testing in Alzheimer’s Disease scale20 (used to measure reactions 
to genetic susceptibility testing results for AD genes), the scale was adapted to PET biomarker disclosure. This 
scale has been previously developed and used as part of the REVEAL study, and has the strength of 
assessing both positive and negative reactions and being specific to Alzheimer’s disease. This measure will be 
administered to both participants and co-participants. 

 
Primary Outcome 3.4 - Stigma Scale for Chronic Illness (SSCI-821). The SSCI-8 demonstrates 
strong reliability for the measurement of both internalized and enacted stigma perceived by individuals with 
chronic neurological conditions. Respondents complete 8 items about experiences of stigma, rated on a Likert-
style scale from 1 = ‘Never’ to 5 = ‘Always.’ This measure will be administered to participants only. 
 
Primary Outcome 3.5 - Self-Efficacy for Managing Chronic Disease Scale (SECD22): The SECD is 
a 6-item scale that measures perceived ability to self-manage the physical, emotional, and cognitive symptoms 
associated with their chronic disease. Items are listed on a 10-point scale ranging from 1 = ‘Not at all confident’ 
to 10 = ‘Totally confident’. Though not previously applied to Alzheimer’s disease specifically, psychometric 
properties for the assessment of self-efficacy across chronic conditions were strong (reliability ranging from 
0.88-0.9523. This measure will be administered to participants only. 
 
Primary Outcome 3.6 - Future Time Perspective Scale (FTP24): This 10-item scale measures the 
extent to which respondents feel that they have potential for productive and functional years ahead of them. 
Statements regarding positive and negative future time perspective are rated on a 7-point Likert-style scale, 
ranging from 1= ‘Very untrue’ to 7=’Very true.’ This measure will be administered to both participants and study 
partners. 
Primary Outcome 4.1 - Preparedness for Caregiving Scale (PCS29,30): This 8-item measure 
assesses the degree to which care partners of persons with cognitive impairment (e.g., MCI, DAT) perceive 
they are prepared for and able to manage various domains of caregiving such as providing physical care and 
emotional support, setting up in-home support services, and coping with stress due to caregiving. Items use a 
5-point likert scale ranging from 0 = ‘Not at all prepared’ to 4 ‘Very well prepared’. The PCS has demonstrated 
strong psychometric properties for assessing perceived readiness for caregiving among family members of 
persons with Alzheimer’s disease dementia. This measure will be administered to study partners only. 
 
Primary Outcome 4.2 - Revised Scale for Caregiving Self-Efficacy (RSSE31): The Revised Scale for 
Caregiving Self-Efficacy is a 15-item scale consisting of 3 sub-scales, each containing 5-items, designed to 
measure perceived ability to manage aspects related to caregiving among caregivers of persons with 
dementia. A single subscale consisting of 5-items will be used to measure co-participant’s perceived ability to 
manage the emotional stresses associated with caregiving. This measure will be administered to study 
partners only. 
Table 4. Outcome Measure Summary 
Construct/Measure 
Group 
(Participant, Study 
Partner, or Both) 
Data Collection Timepoint 
Pre-
Disclosure 
(Education 
Session) 
 
Immediate 
Post-
Disclosure 
1-week 
6-weeks 
Positive and Negative 
Affective Scale – Short 
Form 
Both 
X 
X 
X 
X 
Impact of Neuroimaging in 
Alzheimer’s Disease 
Both 
 
X 
X 
X 
Future Time Perspective 
Scale 
Both 
X 
X 
X 
X 
Stigma Scale for Chronic 
Illness 
Participant 
X 
X 
X 
X 
Self-Efficacy for Managing 
Chronic Disease Scale 
Participant 
X 
X 
X 
X 
Revised Scale for 
Caregiving Self-Efficacy 
Study Partner 
X 
 
X 
X 

Preparedness for 
Caregiving 
Study Partner 
X 
 
X 
X 
 
 
SECTION 3.5 DATA MANAGEMENT & ANALYSIS 
 
3.5.1 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. 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 locked, 
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. A centralized database for all outcomes will be saved 
on the University of Michigan secure server as a password-protected file only accessible by approved study 
personnel. 
 
The participants’ PET amyloid and tau data will not be requested or added to this database until completion of 
Part I Education & Decision-Making Assessment, to ensure no implicit bias in the manner in which Part I 
procedures are conducted based on participant risk. At this time, data from eligible participants enrolled in the 
Part II Disclosure will be accessed. De-identified participant information, coded with the parent study ID 
number, will be shared with the study team as a secure excel database and transferred to the centralized study 
database.  
 
3.5.2 Statistical Design 
 
Data Screening 
 
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.  
 
Statistical Approach 
 
To assess Aim 1, we will compare the proportion of individuals in each diagnostic group who request vs. 
completed disclosure using a chi-squared test. Similarly, we will test hypotheses associated with Aim 2 
(greater disclosure decisional capacity in MCI than DAT) by comparing the proportion of individuals in the DAT 
and MCI groups who demonstrate ‘pass’ scores on the DDMAT using a chi-squared test. We will also explore 
which particular elements of decision-making capacity may be more impaired in each group by comparing 
proportion of each diagnostic group who can adequately demonstrate understanding, appreciation, rationale, 
and communication on the DMAT using the same statistical strategy. To evaluate Aim 3, (psychological 
reactions based on biomarker status) we will compare participants’ and co-participants’ responses on outcome 
measures, based on amyloid and/or tau positivity vs. biomarker negativity. As we expect outcome measures to 
be correlated, we will utilize a 2 (diagnosis: MCI vs. DAT) by 2 (biomarker status: positive vs. negative) 
repeated measures analysis of variance (rmANOVA) approach for each follow-up time point. We will also 
compare differences in psychological reactions between participants and co-participants by diagnosis (MCI vs. 
DAT) using a paired t-test on all continuous items and a chi-squared test on categorical items. To evaluate Aim 
4 (impact of biomarker disclosure on co-participant caregiving readiness and self-efficacy), we will similarly 
compare co-participants’ responses, based on amyloid and/or tau positivity vs. biomarker negativity. As we 
expect outcome measures to be correlated, we will utilize a 2 (participant’s diagnosis: MCI vs. DAT) by 2 
(biomarker status: positive vs. negative) repeated measures analysis of variance (rmANOVA) approach for 
each follow-up time point. 
 

 
SECTION 4: MONITORING 
 
4.1 Risk Monitoring 
 
4.1.1 Part I: Education & Decision-Making Assessment 
 
Participants who endorse current/active depression, anxiety, or other significant psychological disorder 
will be excluded from the study. Prior to other study activities but after informed consent has been 
provided, participants will be screened using the Geriatric Depression Scale – 15 Item version (GDS-
15)1 and the Beck Anxiety Inventory (BAI)2 to ensure no active depressive/anxiety symptoms. Each of 
the measures have empirically supported cut-off scores (GDS-15 ≥ 9; BAI ≥ 16) for determining 
clinically significant depression, anxiety, and event-related distress; individuals who endorse clinically 
significant depression or anxiety on the GDS-15 or BAI will be withdrawn from the study prior to further 
participation. These measures will be repeated at each of the three follow-up time points (immediate, 
within 1 week, 6 weeks) to assess change in mood or anxiety symptoms; those with elevations at or 
above the cutoffs noted above will complete an additional assessment with a clinically licensed team 
member to determine next steps, adverse events, and resources. Additionally, participants complete 
the INI-AD at the immediate, one-week, and six-week follow-up sessions. Any participants scoring 24 or 
higher on the distress subscale of the INI-AD will complete a follow-up assessment by a clinically 
licensed study team member. 
 
It is not expected that discussing AD, DAT, and PET disclosure will cause significant distress or 
exacerbation of mood symptoms; however, any participant who appears distressed during the session 
will undergo risk assessment and intervention as needed according to the study safety plan (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 after study completion 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 Part II: Disclosure 
 
It is possible that participants may experience psychological distress as a result of hearing their PET 
results, particularly if this feedback indicates elevated risk. Although DAT risk and biomarker 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 INI-
AD5 post-disclosure as well as both follow-up sessions. Any clinically significant elevation of scores on 
these measures, and/or other indication of new or exacerbated mood symptoms will result in a more 
advanced evaluation by a licensed clinical psychologist (ARF, BMH) or licensed social worker (MM; see 
Appendix A). In addition, participants and co-participants will be given contact information for the study 
team and encouraged to call ARF or MM with any concerns or needs related to their reactions to the 
disclosure session.  
 
4.2 Safety Assessment: At the beginning of each session, the study team member completing the visit will 
confirm the participant’s current location and call-back number to use in case of emergency. In the case of 
safety concerns in either part of the study, a risk assessment and follow-up will be conducted. A licensed 
psychologist (ARF, BMH) or social worker (MM), who will be available to join the sessions virtually or via 
phone, and are also available via page, will evaluate the severity of the participant’s (or co-participant’s) 
psychological symptoms and risk for 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 safety plan is included in Appendix A. 
 

4.3 Adverse Events Reporting: Participant and co-participant mood and distress will be carefully assessed at 
baseline (prior to study activities), following disclosure, and at all follow-up time points using the GDS-15 and 
BAI. These measures will be used to determine (a) whether changes in mood or distress occur, and (b) 
whether these changes are likely attributed to study participation. Each of the measures have empirically 
supported cut-off scores (outlined above) for determining clinically significant depression, anxiety, and event-
related distress; 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 independent safety officer (SO) for this project is Dr. Joshua Grill (jgrill@hs.uci.edu). Dr. Grill is a 
Professor in the University of California Irvine Department of Psychiatry & Human Behavior and Neurobiology 
& Behavior and specializes in Alzheimer’s disease. He has previously served in this capacity for ARF’s risk 
disclosure studies. 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 the SO. 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. There are separate consent forms for Part I: Education & Decision-Making Assessment and Part II: 
Disclosure. A study team member will review the appropriate consent form with the participant and their 
LAR/DPOA as applicable. 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 the 
Consent Decision-Making Assessment Tool (CDMAT), a brief measure asking the participant to use their own 
words to review the contents of each section of the consent form before signing. If the participant no longer 
retains the ability to provide informed consent, the designated LAR/DPOA will be asked to provide consent, 
and the participant will be asked to provide assent. Alternatively, if the participant no longer retains the ability to 
provide consent but brings a co-participant who is not a designated LAR/DPOA, the participant may allow that 
individual to provide consent, and the participant will be asked to provide assent. 
 
As detailed above, these procedures will be completed virtually prior to the first visit to ensure sufficient time to 
answer all questions. The participant will then print, sign, scan, and return the consent form or utilize the 
SignNow modality to electronically sign the document and return it to the study team member, who will sign it. 

The study team member will then download the completed form, and store electronically under password 
protection in the network secure drive. 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. 
 
5.3 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 and any co-participants. For information 
regarding security and confidentiality of data from enrolled participants/co-participants, see ‘Data Management 
& Entry’.  
 
Participants will be made aware prior to enrollment in Part I that they will not receive feedback regarding their 
PET amyloid and tau status during this stage of the study. This option will not be offered to participants until 
completion of and evaluation of responses from Part I. 
 
5.4 Declaration of Interests 
None of the study investigators have any financial or competing interests to declare. 
 
5.5 Access to Data 
Physical study data will remain housed within ARF’s private office 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 and co-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 investigating PET disclosure, which 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.  
 
 
 
 
 

 
 
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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  ≥ 9 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 
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).