Spoken Language Biomarker of Cognitive Impairment in PD
Conditions: Parkinson Disease
Sponsor: Northwestern University

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PROTOCOL TITLE: 
Phase 2 development of a spoken language biomarker of cognitive impairment in 
Parkinson’s disease. 
 
PRINCIPAL INVESTIGATOR: 
Angela Roberts, Ph.D. 
Assistant Professor 
Communication Sciences and Disorders 
 
CO-INVESTIGATOR: 
Dr. Tanya Simuni, Northwestern University 
Dr. Leora Cherney, Northwestern University and Shirley Ryan AbilityLab 
 
STUDENT INVESTIGATOR: 
N/A 
 
VERSION DATE: 
November 17, 2021 
 
1.0 
Purpose of the study: 
 
Aim 1 will characterize PD-MCI (Parkinson’s disease mild cognitive impairment), 
PDN (Parkinson’s disease without cognitive impairment), and HA (healthy adult) 
spoken discourse, cognitive, and motor speech profiles. Phase 2 biomarker 
development requires robustly characterized cohorts in which to test candidate 
biomarkers. Using a standardized battery of cognitive, language, and motor speech tests 
PD participants will be assigned to PD-MCI (single/multi-domain) or PDN groups. We 
propose collecting spoken discourse samples using standardized elicitation protocols. The 
same tasks will be extracted from the extant HA database. Researchers will transcribe, 
code, and analyze discourse samples. Group differences (including sub-analyses for 
single and multi-domain MCI subtypes), elicitation stimuli effects, and group x stimuli 
interactions will be examined using multivariate and mixed-design ANOVA procedures. 
 
Aim 2 will develop and evaluate the classification accuracy of an optimally weighted 
discourse classification function for PD-MCI and PDN. We propose using discriminant 
function analysis to identify an optimized composite variable that best predicts PD-MCI, 
PDN, and HA group membership. Sensitivity/specificity analyses, positive/negative 
predictive values, and receiver operating characteristic curves will be used to evaluate the 
discourse classification function properties. 
 
The primary endpoint is an optimally weighted discourse function that can classify PD- 
MCI with > 80% sensitivity/specificity. 
 
2.0 
Background / Literature Review / Rationale for the study: 
 
Individuals with Parkinson’s disease (PD) have a 6-fold increased risk of dementia.1 PD 
mild cognitive impairment (PD-MCI) is thought to be a transitional state to dementia for 

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many of those affected.1-2 Difficulties monitoring early cognitive impairments, and 
concomitant delays in treatment initiation, are major barriers to the accurate 
diagnosis of and the development of interventions for cognitive impairments in PD.3-5 A 
biomarker is any characteristic that can be objectively measured and indicates 
normal/pathogenic processes or responses to therapeutic interventions.6 Biomarkers can 
be genetic markers, neural markers, and observable behaviors.6 In the absence of 
neuropsychological findings, early dementia can still be detected in spoken discourse.7-10 
Thus, a spoken discourse biomarker can be a valuable supplement to extant 
neuropsychological evaluation for monitoring cognitive-linguistic changes in real 
world environments. The long-term objective of this research is to improve the early 
and accurate diagnosis of PD cognitive impairment with a reliable spoken discourse 
biomarker. Research shows that discourse features including grammar errors, information 
content/efficiency, coherence, and verbal disfluencies hold promise for detecting PD 
cognitive impairments.14-28 Additionally, our pilot suggests that an optimally weighted 
composite variable, and no one single variable, is best able to discriminate PD spoken 
discourse. A major barrier is the absence of a spoken discourse biomarker that has been 
rigorously developed and tested on a meticulously-characterized cohort of PD-MCI, PD 
without cognitive impairment (PDN), and healthy adults (HA). Using the Fit-for-Purpose 
framework, the goal of the proposed research is to complete a Phase 2 spoken 
discourse biomarker study.29 The overarching hypothesis is that PD-MCI and PDN 
will have unique profiles of spoken discourse impairments that are distinguishable from 
each other and from HA. 
 
3.0 
Inclusion and Exclusion Criteria: 
 
Only individuals with PD will be newly recruited and enrolled as part of the study. 
Healthy adult data will be extracted from extant databases (publicly available) from NIH- 
funded studies. 
 
Inclusion Criteria Person with Parkinson’s disease without cognitive impairment 
• 
Age 50-90 years 
• 
Diagnosis of idiopathic Parkinson’s disease (UK Brain Bank criteria) made by a 
movement disorders specialist 
• 
Under the care of a movement disorders specialist for a minimum of 1-year 
duration 
• 
Native monolingual English speaker 
• 
Hoehn & Yahr score between 1.5 and 4 
• 
Grade 10 education, or higher 
• 
Sufficient vision and hearing (aided or unaided) for all experiment tasks 
• 
Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than 
or equal to 25 
• 
No subjective complaints of cognitive difficulty or word finding issues 
 
Inclusion Criteria Person with Parkinson’s disease mild cognitive impairment 
• 
Age 50-90 years 
• 
Diagnosis of idiopathic Parkinson’s disease (UK Brain Bank criteria) made by a 
movement disorders specialist 

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• 
Under the care of a movement disorders specialist for a minimum of 1-year 
duration 
• 
Native monolingual English speaker 
• 
Hoehn & Yahr score between 1.5 and 4 
• 
Grade 10 education, or higher 
• 
Sufficient vision and hearing (aided or unaided) for all experiment tasks 
• 
Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than 
or equal to 17 
• 
Subjective complaints of cognitive difficulty or word finding issues, without 
significant impact on activities of daily living 
 
Inclusion Healthy Adults (from extant data base – no new recruiting) 
• 
Age 50-90 years 
• 
Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than 
or equal to 26 
• 
Native monolingual English speaker 
• 
Grade 10 education, or higher 
• 
Sufficient vision and hearing (aided or unaided) for all experiment tasks 
 
Exclusion Criteria Neurological injury or disease (other than PD for the PD cohort) 
• 
History of unmanaged or untreated depression or major psychiatric illness 
• 
History of deep brain stimulation surgery (DBS) 
• 
Diagnosis of Dementia with Lewy Bodies 
 
Hearing and Vision Screening. PD participants will complete the protocol using their 
typical vision and hearing devices. PD participants with pure tone averages > 41 dB 
(either ear), who do not have their own assisted listening device, will be fitted with a 
personal amplifier only during test/task instructions and test item presentation. 
Participants will complete vision acuity and field screening tasks to confirm sufficient 
visual acuity (aided or unaided) and in-tact visual fields for the discourse tasks. 
 
4.0 
Sample Size: 
 
We will enroll 86 PD participants (43 individuals with PD and normal cognition and 43 
individuals with PD mild cognitive impairment). Data from 43 age/education/sex 
matched HA will be sampled from an extant repository. 
 
Sample sizes for ANOVA and DFA were calculated using G*Power. For Aim 1, a sample 
of 129 participants for MANOVA procedures with 3 IVs (PD-MCI, PDN, HA), 15 
dependent variables (6 canonical variables), and up to 3 covariates will detect a 
minimum of
2 of 0.16 (medium-sized effects) with power of 0.90, and α=0.05. The 
available effect size estimates for the 8 candidate discourse variables range from f
2 of 
0.33 to 0.50 (medium to large effects). With the smallest anticipated effect size based on 
our pilot data (f
2 =.33) 129 participants in a mixed ANOVA with 2 IVs (Group [3 levels]) 
and Task [2 levels]) with up to 2 covariates will yield power of 0.86, α=0.05. At the 
highest estimated effect size (f
2 =.50), the same sample size will yield power of 0.99, 
α=0.05. For Aim 2, DFA procedures with 3 groups and 8 discourse variables with 129 

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participants will detect f
2 of .10 (small-medium effects) with power of 0.90, α=0.05 and 
power of 0.85, if α=0.025. For the sensitivity and specificity analyses a sample of 129 
participants will detect sensitivity and specificity values of 0.83 or higher with a 90% 
confidence interval precision of 0.10, given an expected disease (PD-MCI) prevalence of 
30%, a conservative prevalence estimate. This precision level is consistent with 
guidelines for Phase 2 studies. 
 
5.0 
Research Locations: 
 
New Data Collection 
All data collection will take place at Northwestern University, Evanston campus, the 
Northwestern University Department of Communication Sciences and Disorders flexible 
laboratory research space located in Abbott Hall on the Chicago campus, or alternatively 
in participant homes through in-person or virtual visits if individuals are not able to 
physically travel to our locations. 
 
Data will be collected in a dedicated research space (or participant home). Data will be 
collected in a low distraction, accessible environment specifically designed for the 
collection of discourse and neuropsychology testing data. If data are collected in a 
participant’s home, efforts will be made to create a low-distraction quiet environment 
consistent with the research spaces located on the Evanston and Chicago campuses. 
 
Data will also be collected virtually through Zoom videoconferencing. Similar efforts to in- 
person data collection in participants’ homes will be made to replicate low-distraction 
environments consistent with the research spaces on the Evanston and Chicago 
campuses. A HIPAA-compliant, end-to-end encrypted version of Zoom will be used for 
study visits to comply with strict personal health information protection guidelines. If 
participants do not have access to a personal computer capable of running the 
necessary videoconferencing software, a microphone for audio recording, or a webcam 
for videorecording we mail or drop off necessary hardware to their homes. 
 
Extant Data Collection (Healthy Adult data) 
Demographic data and neuropsychology testing measures for the healthy control sample 
will be secured from an extant dataset in a secure repository ICPSR 3664 (Harris Wright, 
Heather, and Capilouto, Gilson J. Discourse Processing in Healthy Aging in the United 
States. Ann Arbor, MI: Inter-university Consortium for Political and Social Research 
[distributor], 2017-03-02. https://doi.org/10.3886/ICPSR36634.v1). Audio and video files 
of spoken discourse samples for the same study (study of normal aging and discourse) 
are curated with the Carolina Conversations Collection and are available for use in 
research with an approved IRB (http://carolinaconversations.musc.edu/about/). 
 
6.0 
Multiple sites: 
 
Shirley Ryan AbilityLab – Dr. Leora Cherney who has faculty appointments at both NU 
Evanston (Communication Sciences and Disorders) and the Shirley Ryan AbilityLab is a 
co-investigator. Dr. Cherney’s involvement is limited to providing mentorship to the PI 
on grant administration, serving in a consultative role for resolving discourse coding 
ambiguities, and supporting the PI in interpreting the study results. While Dr. Cherney 
may have a limited role in recruiting participants with Parkinson’s disease, no data will 

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be collected from, nor will any health records be required from, the Shirley Ryan 
AbilityLab. 
 
Feinberg – Dr. Tanya Simuni is on faculty at Feinberg. Dr. Simuni will be involved with 
recruiting (not enrolling) participants. She will also be involved with the design of the 
study and the interpretation of the results. Dr. Simuni will also provide medical guidance 
and PD expertise as required during the study. The study does not require access to 
patient records at NMH. 
 
7.0 
Reliance Agreements/Single IRB: 
 
NU is the IRB of record for both the Shirley Ryan AbilityLab and Feinberg. To the PIs 
knowledge no additional IRB permissions or reliance agreements are required. 
 
8.0 
Procedures Involved: 
 
The proposed study is not a clinical trial and was not deemed as such by the NIH. 
 
C. APPROACH 
 
Observational, cross-sectional study with three cohorts: healthy older adults, individuals 
with Parkinson’s disease without cognitive impairment, and individuals with Parkinson’s 
disease with mild cognitive impairment. 
 
Data Sources 
Measures collected on all PD participants. Only PD participants will be recruited 
locally. All healthy control data will be extracted from extant databases available through 
data sharing agreements or publicly accessible datasets. All measures will be audio and 
video recorded in order to facilitate off-line data analysis for standardized measures and 
orthographic transcription of discourse samples. If the participant has completed any of 
the neuropsychological testing measures in our lab within the last 6-months, and a 
suitable alternate version of that test is not available, we will use their previous data in 
order to reduce participant burden and data contamination (e.g., learning effects from 
previous test administrations). 
 
In the PD group measures will be collected over 1 or 2 visits (conducted within a 4-week 
window), depending on participant fatigue levels/scheduling. Each participant’s total 
involvement is anticipated at 3 to 3.5 hours in duration. The typical participant is 
anticipated to complete the protocol in one visit. 
 
All tests will be administered by trained research staff. All measures will be administered 
and scored in accordance with their published manuals/scoring instructions. 
 
Participants may complete the protocol in our Evanston lab, satellite lab in Abbott Hall, 
or their home through in-person or remote visits. Participants will be able to select a time 
of day of their choosing for completing the protocol. 
 
The total duration of the research project is estimated at 36 months. 

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The study visit will be conducted in two stages: a screening portion and the experiment 
portion. With the exception of the cognitive testing, hearing testing, and vision testing all 
other inclusion criteria will be evaluated during the initial phone, email, or in-person 
contact with the participant when interest in the study is expressed. 
 
Participants will receive reminder calls regarding upcoming appointments. These will 
typically occur within 72 hours of the scheduled appointment. During the telephone 
 
Descriptive Variables 
Geriatric Depression Scale – brief depression screening tool. Depression can interact with 
language production abilities. 
MDS-Unified Parkinson Disease Rating Scale – measure of PD motor symptoms. Completed 
through physical exam by a certified research assistant or the PI. 
Hoehn and Yahr scale – PD staging tool completed as part of the motor exam 
Communication Participation Item Bank measure – pen and paper tool measuring communication 
quality of life 
reminder call, staff members will complete the Participant/Visitor health screener for 
(attached to protocol). If participants answer ‘yes’ to any item, staff members will request 
that their study visit be rescheduled at a time that is convenient for the participant. If the 
participant answers ‘yes’ to any of the questions under the ‘Travel’ heading then they will 
be provided with the COVID-19 contact information handout (attached). This information 
will be emailed to the participant if required. Information will also be provided over the 
telephone including the email and telephone contacts for the Illinois Department of Public 
Health. 
 
If the participant cannot be contacted by telephone, the screening form can be completed 
in person at the time of the study visit (but prior to initiating any substantial participant 
contact). Visitors who accompany the participant will also be asked to complete a health 
screener, if they intend to wait in the research lab lobby space. Health screening tools will 
be stored in a locked filing cabinet in the PIs lab for a period of 60 days following the 
participant’s visit. Following this period, forms will be shredded using secure shredding 
boxes located in the NUCASLL clinic/PIs home department (CSD). 
 
During the screening portion of the visit, participants will complete the Montreal 
Cognitive Assessment (MoCA), an audiometric hearing assessment, and a vision 
screening using a Snellen eye chart. Participants meeting the inclusion criteria for the 
study will advance immediately to the experiment tasks. Those not meeting the inclusion 
criteria will be provided summary results, including the criteria that they did not meet 
(i.e., cognition, hearing, vision) and will be advised to discuss these results with their 
healthcare team. 
 
During the experiment portion of the visit participants will complete the following tasks: 
 
Descriptive and Neuropsychological Testing Measures – The measures in the table below 
are standard descriptive measures for the population and the research aims under study. 
These are all standard clinical measures in PD clinical practice. Standardized language 
and cognitive neuropsychological measures will be used to stratify participants into PD- 
MCI and PD normal cognition groups using the Movement Disorders Society Task Force 
published guidelines. 

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Sentence Intelligibility Test (SIT-5). Set of 11-sentences generated for each participant. Sentences 
are phonetically balanced and are read aloud by the participant. Measure of speech intelligibility 
Standardized oral reading passage (speech rate and intelligibility) 
Brief motor speech exam 
Demographic form (attached) 
National Adult Reading Test 
Neuropsychological Measures Used in Primary Analyses and to Classify Participants into 
MCI-PD from PDN (no cognitive impairment) groups 
Trail Making Test-A (In-person testing) 
Trail Making Test-B (In person testing) 
10-points Clock Drawing Test + Clock copying 
Free and Cued Selective Reminding Test from the Arizona Battery of Communication Disorders of 
Dementia (In-person testing) 
Brief Visuospatial Memory Test-Revised 
Semantic Fluency-animals 
Digit span forward and backward 
Stroop Color-word Interference 
Boston Naming Test (30-item version) 
Verb Naming Subtest – Northwestern Assessment of Verbs and Sentences 
Sentence Production Priming subtest of the Northwestern Assessment of Verbs and Sentences 
Pyramids and Palm Trees Test - object semantics 
CERAD 10-Word List (Remote testing) 
Discourse Sampling (main study outcome measure) 
Using standardized spoken discourse elicitation stimuli and instructions, participants will 
be asked to generate a story about a series of events occurring in: 1) a series of six 
black and white line drawings and 2) a wordless picture book. Participants will generate 
a maximum of four spoken discourse samples. Each discourse sample is estimated at 2 
to 4 minutes in length. Audio files will be transcribed using a HIPAA compliant 
transcription service/software. Once transcribed, files will be coded in Dr. Roberts’ lab for 
a number of discourse (e.g., story structure, information content), speech (e.g., pauses, 
number of words), and language variables (e.g., grammar/syntax). 
 
Proposed Data Analysis 
Aim 1 
Multivariate ANOVA statistical procedures will be used to examine group differences on 
neuropsychological test measures and spoken discourse measures. Follow-up 
univariate ANOVAs and Tukey’s post-hoc tests will be used to further examine 
significant individual variables from the multivariate testing and to examine group 
contrasts (healthy controls, PD without cognitive impairment, and PD-MCI). If required 
based on group differences in descriptive variables age, sex, depression measure 
scores, and education will be entered as covariates. 
Aim 2 
The spoken discourse measure data will be used in a canonical discriminant function 
analysis (DFA) to identify the optimal discourse classification functions that separate 
groups. DFA is a multivariate procedure that is used to predict group membership. In our 

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case, where there are > 2 diagnostic groups, Wilks’ lambda values, in a stepwise 
approach, will be used to identify the final set of variables that account for the maximal 
variance for group differences. This step will eliminate variables that do not contribute 
significantly to group variance. Redundant variables will also be deleted. The DFA 
approach will yield multiple potential models that will be evaluated for classification 
accuracy using sensitivity and specificity analyses. Receiver operating characteristic 
curves will be used to evaluate discriminant function accuracies as discrimination 
thresholds vary. 
 
Vulnerable Populations 
All consent procedures for individuals with cognitive impairment will be conducted by 
individuals who are experienced in facilitating communication with individuals who have 
communication and cognitive difficulties. Family members of those with cognitive 
impairment may be present during the consent process if requested. The study will 
recruit individuals with normal cognition and those with mild cognitive impairment. While 
it is possible that we will need to use alternate consent procedures, the mild severity of 
cognitive issues in this population, leads us to anticipate that participants will be able to 
provide their own consent (with supported communication). We anticipate only rare 
cases where this will not be true. 
 
9.0 
Incomplete Disclosure or Deception: 
 
N/A 
 
10.0 Recruitment Methods: 
Participants will be recruited through their primary care provider (or associated clinic), 
through movement disorders specialists (or associated clinic), through community-based 
support groups/wellness programs that serve individuals with Parkinson’s disease, 
through formal research participation registries, through community outreach activities 
(e.g., health fairs, education events), through social media/community postings, and 
through senior community living facilities. A variety of methods including direct referral 
by a health care professional, flyers, on-line advertising (PI’s website and approved 
social media), and recruiting events held at local support groups/wellness centers will be 
used to optimize recruitment. Participants recruited through support/wellness groups or 
other community resources will contact the PI or study coordinator/team member directly 
to confirm their interest in the study and will be invited to participate if they meet the 
eligibility criteria. Only materials approved by the IRB at Northwestern University will be 
used. 
 
11.0 Consent Process: 
Written consent will be obtained from all participants completing in-person assessments, 
or their surrogate decision makers (when appropriate). Participants completing the 
virtual assessment may provide either written or verbal consent, based on their 
preference and ease of using the REDCap interface. Consent will be obtained by a 
research study team member and will be secured in one of the three potential study 
locations: PI’s lab on the Evanston campus, satellite lab in Abbott Hall, or the 
participant’s home. When requested, consent documents may be sent to the participant 
ahead of their scheduled screening appointment for advanced review. If enrolled in the 
remote protocol, participants will be scheduled for two videoconferencing sessions. The 

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first session will be held prior to their study visit to acquire consent from the participant. If 
completing the protocol remotely, and written consent is the chosen mode of providing 
consent, consent forms will be sent to participants through email and e-consent will be 
received through a REDCap survey during their first study visit before any tests are 
administered. Otherwise, if choosing verbal consent, consent will be obtained, noted on 
the consent form, and captured in the recording of the video conference session. 
 
The consent process indicates that participation is voluntary and that he/she has the 
right to withdraw from the study at any time or to refuse any procedure within the study. 
Risks and benefits of the study are conveyed in a written consent document and also 
described orally during the consent process. 
 
Multi-modality communication supports are used by trained personnel (speech-language 
pathologists or experienced research staff) who are experienced with facilitating 
communication in individuals with cognitive and language impairments in order to 
facilitate a participant’s ability to understand the consent documents. 
 
After explaining the study protocol, participants will be interviewed to assess their 
understanding of the study aims, the requirements of the study protocol, potential risks, 
potential benefits, that participation is voluntary, and that they are able to withdraw at 
any time using a lab-developed questionnaire for obtaining informed consent from 
individuals with cognitive impairments (see uploaded documents). If potential 
participants are not able to answer these questions, the research team will provide 
further education to raise their understanding to sufficient levels for making an informed 
consent about study participation. Procedures may include repeating information, 
simplification of language form/content, segmenting content into small units of 
information, and multi-modal communication support (e.g., pictures, gestures). The 
estimated duration of the consent process is between 20 and 30 minutes, but this is 
highly variable across individuals. 
 
It is likely that participants will be able to provide their own consent. However, if not able 
to do so, participants may choose to have another party sign/provide consent on their 
behalf. This individual would be the authorized decision maker for the affected person 
(e.g., spouse, child, or SDM if appropriate). 
 
HIPAA consent is not applicable. 
 
12.0 Financial Compensation: 
Participants will have no direct cost associated with the study. Participant parking will be 
covered if they are required to travel to the downtown or Evanston lab spaces. 
Participants will be compensated in the form of a $25.00 Stored Value Card (purchased 
through NU Research Services) to account for time and travel costs. Stored Value Cards 
will be provided at the conclusion of the study protocol (typically one study visit). 
Compensation will not be prorated. 
 
13.0 Audio/Video Recording/Photography 
Neuropsychological testing will be audio and video recorded. This is essential because: 
a) Some items in these tests require off-line assessment to verify participant 
responses and to ensure rigorous scoring of the test measures used to stratify 

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participants. Audio and video recordings allow us to disambiguate any 
questionable responses. 
b) As part of our research protocols, we double-score a percentage of the test 
measures to increase the rigor of the data set. 
c) Audio and Video recordings are reviewed regularly, as part of the study protocol, 
to assess test administration fidelity throughout the duration of the study. 
d) Consenting to the use of audio and video recordings of the neuropsychological 
testing for the purposes of data analysis is mandatory. 
 
Spoken discourse samples will be audio and video recorded. This is essential because: 
a) The primary analyses conducted on these data require off-line orthographic 
transcription and fine-grain coding of linguistic and speech errors. 
b) Audio and video recording of discourse samples is a standard procedure for 
discourse analysis research and considered an essential step in rigorous 
research. 
c) Consenting to the use of audio and video recordings of the discourse data for the 
purpose of data analysis is mandatory. 
 
Presentations (optional) 
a) Audio recordings only (no video) of the discourse samples only may be used for 
presentations where research generated from these recordings is being 
presented. There are elements of these analyses (e.g., pausing, verbal 
disfluencies, speech errors) that are best exemplified through the original source 
records (i.e., audio recordings) vs. the orthographic transcription. 
b) When used for illustrating study results/findings, audio recordings will not be 
distributed to the audience broadly. They will be played as part of the 
presentation, but the audio file will not be embedded into the slide deck or 
distributed in any way to the attendees. 
c) Participants will be allowed to opt out of the use of audio recordings for 
presentations. This is not a mandatory element of the study. 
 
Audio and video recordings will be stored on the LCAN (Dr. Roberts’) research server. 
Only approved study personnel (listed on the IRB application) will have access to the 
audio and video recordings. Recordings will be stored for a duration of at least 7-years 
(and potentially longer) following the end of the NIH grant funding period. When 
destroyed, audio and video recordings will be destroyed using the most up-to-date and 
secure procedures for doing so at the time of their destruction and will be completed in 
consultation with local University IT services. 
 
14.0 Potential Benefits to Participants: 
 
Although there is no direct benefit to participants, they and their families often consider 
us an unbiased source of disease-related education on communication impairments in 
Parkinson’s disease. When requested, our team is able to provide contacts to 
participants for foundations and agencies that focus on Parkinson’s disease education 
(e.g., local support groups, printed education materials, national/local education events 
and materials). 
15.0 Risks to Participants: 

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The risks involved with this study are not substantially different from those associated 
with typical clinic visits. Participants may experience fatigue owing to the duration of the 
protocol. If enrolled in the remote protocol, participants may experience fatigue 
commonly associated with using videoconferencing software for extended periods of 
time. In our experience administering a similar duration neuropsychological assessment 
protocol within the Ontario Neurodegeneration Diseases Initiative, fewer than 5% of 160 
PD participants required two data collection visits. 
 
Some participants may experience a sense of emotional discomfort from being 
video/audio recorded during these sessions. Video and audio recording are routine 
during Parkinson’s-disease related clinical sessions. 
 
We anticipate that all participants with cognitive impairments will be aware that they 
have cognitive issues. However, it is possible that our testing may reveal deficits of 
which the participant was previously unaware and thus may present a potential risk of 
distress associated with this concern. 
 
Some participants may perceive a sense of nervousness when completing mood and 
cognitive testing, particularly the depression measure. Participants will be able to refuse 
any task that makes them uncomfortable. 
 
There are no anticipated physical risks associated with this study. 
 
While efforts will be taken to protect participant confidentiality, there is always a risk that 
confidentiality may be breached. The primary risk of breaching confidentiality in the 
current study arises from the need to audio/video record data collection sessions. 
 
There are no anticipated social or legal risks. 
 
There are no costs associated with the study. Participants’ parking will be covered for all 
visits. We will also provide a nominal study participation fee to help accommodate for 
travel and time-related expenses. 
 
Risk level. The overall risk level is low and impact to participants is anticipated to be 
minimal. This assessment is based on a number of projects in the PI’s lab that employ 
similar procedures, research designs, and methods. 
 
Minimizing Risks. 
Fatigue. To minimize fatigue, participants will be offered rest breaks every 60 minutes. 
However, participants may request and be granted a rest break at any time. If the testing 
session is too long for some participants, we will break testing into two data collection 
visits. Participants will be allowed to select their ‘best’ time of day for their data collection 
session. This step will allow participants to complete the protocol at their typical peak 
performance time of day. The protocol will be conducted with PD participants in their ‘on’ 
medication state. Doing so will promote participant comfort and minimize mobility/pain 
risks associated with ‘off’ medication states. When required, participants will be provided 
with a break for taking medications during the data collection session. 
 
Emotional discomfort audio/video recording. Some participants may experience a 
sense of emotional discomfort from being video/audio recorded during these sessions. 

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To minimize any sense of emotional discomfort, the audio/video recording equipment will 
be positioned discretely in the lab (or home) environment. 
 
Unmasking of previously unknown deficits or emotional distress associated with 
completing measures of cognition/depression. In cases where the participant 
demonstrates (or voices) emotional distress over the challenges of living with 
communication, mood, or cognitive difficulties or where specific tests trigger unpleasant 
feelings over concerns with these issues, appropriate counseling will be provided by the 
PI (a SLP or the medical consultant Dr. Simuni). Issues falling outside of the PI’s scope 
of practice (e.g., indicators of significant depression) will be discussed with Dr. Simuni 
and further follow-up planned. In cases where a participant fails the cognition, vision, 
and/or hearing screenings they will be provided with a summary of these findings that 
they can share with their healthcare team to facilitate appropriate follow-up. In cases, 
where risk of self-harm (including suicidal ideations) or a Geriatric Depression Screening 
score is > 10 participants will be provided with a Mental Health recommendation form 
based on the NIH standard (see attached). Participants at elevated risk for self-harm 
(frank voicing of suicidal ideations or plans to self-harm) will be referred to the nearest 
emergency room (Northshore Evanston Hospital), in addition to the other procedures. 
 
Potential Confidentiality Breaches. See below 
 
Withdrawing from the Study. Consent is voluntary. A participant is free to withdraw from 
the study at any point in time. If a participant withdraws from the study, a summary of their 
treatment progress (up to the point of withdrawal) will remain in the research record and 
may be included in the analysis. However, no further data will be collected. The data 
collected from the participants up and until the point of withdrawal will remain in the study. 
 
 
16.0 Provisions to Protect the Privacy and Confidentiality of 
Participants and the Research Data: 
 
All study procedures will be conducted in private research/clinical facilities with no 
general public access. 
 
To ensure that participants feel comfortable during the administration of study tasks, 
individuals collecting data will be experienced study team members from the PI’s lab. 
They have experience interacting with older adults and those with communication 
difficulties. Task instructions will be provided both verbally and in writing to elevate 
participant understanding, and to minimize any perceived or real intrusion into privacy. 
Questions posed as part of the study are limited in intrusiveness. All interviews will be 
conducted in a relaxed environment without time pressure for responding. Participants 
may refuse to provide a response to a question and or to complete any task asked of 
them. 
 
Only research team members directly involved with the project will have access to 
participant data. Data (specifically any audio files) will be accessed from a secure 
research server or from the project-specific REDCap database using a secure 
Northwestern University network access. 

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At times, participants may request, or we may have need to, share information with the 
participant’s medical team (e.g., indication of severe depression). In these unusual 
circumstances, we will obtain explicit permission from the participant to do so. 
 
Protection of source materials 
Pen and paper test forms, questionnaires, demographic history forms. These 
source materials will be labelled using unique participant numbers that do not contain 
any personal health information. All information will be entered into, stored, and 
accessed via a study-specific REDCap database. Only study personnel will have access 
to the database. Data will be entered into fillable fields, and original .pdf forms of all 
measures uploaded to the secure REDCap database for storage. 
 
If enrolled in the remote protocol, participants will be mailed paper test forms for 
demographic measures through a local mail courier to be filled out after they have been 
consented and before their study visit. Participants will then mail these forms back to the 
main lab location on Northwestern’s Evanston campus in a prepaid envelope. As soon 
as the paper measures arrive at the Evanston campus, research personnel will handle 
the forms in the same manner as paper measures from the in-person protocol. 
 
Audio/Video files. These source materials will be labelled using unique participant 
numbers that do not contain any personal health information. This will facilitate linking 
the audio/video data to the other source materials collected from participants. All study 
related audio/video recordings will be archived on the PI’s secure research server (see 
Facilities document). 
 
Orthographic transcription will be completed using a combination of automated and post- 
automated manual correction procedures. Only the audio files (no video) will be used in 
any of the automated applications. The automated analysis application selected for this 
project is a HIPAA compliant service. Specific mechanisms will be used to ensure data 
safety during this process including secure physical access, authenticated access 
privileges and secure file transfer, audit trails, and data encryption through upload and 
download processes (on both ends of the data management chain) using 128-bit 
encryption and 128-bit SSL encryption. Once transcribed orthographic representations of 
the audio files will be realigned with the video files (stored only on PI Roberts’ server) 
and then used in the linguistic coding and analysis procedures. All secondary file editing 
(post automatic transcription) and coding of the orthographic transcriptions will be 
handled in Dr. Roberts’ lab by trained, qualified research personnel. 
 
For all audio/video recordings taking place in participant homes (if participant is unable 
to come into the lab), care will be taken in the recording setup to scan and remove from 
the recording environment any materials that may reveal personal health information 
(e.g., mail with an address label, medical visit reminder), pictures of other individuals not 
consented into the study (e.g., pictures of children), and any other similar potential 
identifying materials. 
 
Audio and video recording for the virtual protocol will be done through a HIPAA 
compliant, encrypted videoconferencing software using a lab supplied microphone and 
webcam. Recording equipment will be dropped off at participants’ homes if they are local 
to the area or mailed to participants with a prepaid return label through a courier service. 
Audio and video recordings will be stored on the research administrator’s security- 

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compliant, Northwestern University provided computer and then transferred to the 
secure lab server after each session. 
 
Orthographic transcriptions. The discourse elicitation tasks used in the protocol have 
been used previously in the PI’s lab. These stimuli elicit stories about the characters 
portrayed in the picture stimuli. In our experience, it is very rare that individuals add or 
augment these stories with personal information. However, if this does occur, we will 
redact all personally identifying comments from the orthographically transcribed files. 
 
Data handling. Data from paper forms of tests/tasks will be entered into REDCap within 
72 hours of data collection. Once the data are entered into REDCap, verified, and all 
reliability testing completed the original paper versions of the forms will be stored in a 
locked filing cabinet in the PI’s lab located at Northwestern University. Paper copies of 
REDCap stored data will be stored for 7 years following the conclusion of the funding 
period and then destroyed using HIPAA compliant receptacles and procedures located 
in the Northwestern University Center for Audiology Speech Language and Learning. 
 
Audio/video files will be stored on Dr. Roberts’ secure lab research server maintained by 
Northwestern University and accessible only by those with access through the study. All 
audio and video recordings will be made using equipment that has redundant recording 
channels (two copies of all data files) to minimize data loss. 
 
To further minimize confidentiality breaches, audio/video files collected in the lab space 
in Abbott Hall will be uploaded to the LCAN (Dr. Roberts) secure research server prior to 
the study team returning to the Evanston campus. SD drives used to collect the 
audio/video data will be erased prior to transporting to the Evanston campus. Paper test 
forms (de-identified) and consent forms will be transported in a locked case that will 
remain in the possession of the study team member until the information can be secured 
in the PI’s main lab located on the Evanston campus. The same procedures will be 
followed when data are collected in the participant’s home with the exception of the 
audio/video files. Uploading data from the participant’s home is not feasible based on a) 
the lack of access to a secure server and b) the time required to upload data files. In 
these cases, we will encrypt the audio/video data prior to leaving the participant’s home 
and transport it in an encrypted format to the Evanston campus using the same locked 
case for transporting paper forms. 
 
Basic personal information (e.g., first name, contact information) will be collected for the 
purposes of scheduling study visits. This information will be stored electronically on the 
LCAN server, accessed only by lab personnel, and will not be linked to the unique 
participant identifiers. 
 
Given the possibility that individuals may need to complete data collection in their homes 
(e.g., weather, mobility issues), we may need to retain information such as address and 
phone numbers to facilitate study logistics. These data will be stored on the secure lab 
server. Research staff in the ‘field’ will have access to this information but only when 
logging into the server using a secure Northwestern University VPN. Study personnel 
may enter the address into a GPS based device for direction-finding purposes but will be 
prohibited from storing the address or contact information in any identifiable manner on 
any portable device (e.g., cell phone). Phone devices will be supplied by the study. 
Following the completion of the study, these devices will be ‘wiped’ and reset to delete 

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any cached files. Staff personnel will be prohibited from storing any identifiable 
information on these portable devices. 
17.0 Data Monitoring Plan to Ensure the Safety of Participants: 
We will provide training to all personnel who handle data that includes HIPAA training, 
Good Clinical Practice (GCP) training and Social and Behavioral Science IRB training. 
 
Overall framework for safety monitoring. Adverse events (AE), serious adverse events 
(SAE), unanticipated problems, unusual participant behavior, and protocol exceptions will 
be documented in an online database (REDCap) after every session. Adverse events 
include: (a) participant psychological stress (crying that last more than 5 minutes), (b) an 
episode of physical or verbal aggression and/or resistance by the participant or their 
accompanying partner, and (c) minor injury to the participant or the research staff member 
that does not require medical treatment. In this trial, serious adverse events include: (a) 
more than minor injury to the participant or the intervention provider that requires any form 
of medical treatment and (b) hospitalization, institutional care, or death of a participant due 
to natural progression of underlying health conditions or accidental injury unrelated to the 
study protocol (e.g., automobile accident). 
 
Frequency of monitoring. The PI (or her proxy designate) will receive an automatic email 
notification each time an AE or SAE report is completed in the study’s electronic 
documentation system (REDCap). Additionally, aggregate safety and protocol exception 
monitoring reports will be gathered weekly, placed into a central document, and reviewed 
by the PI during weekly research meetings. In consultation with Dr. Simuni, documentable 
action plans will be generated from these meetings to minimize future safety issues. 
 
Process for managing and reporting adverse events/protocol exceptions. After each visit, 
research staff will complete an on-line session log in which they are prompted to report if 
an adverse event or protocol exception occurred. AEs and SAEs are predefined before 
the start of the study (as described above). Protocol exceptions are predefined as any 
variation from the documented study procedures/IRB approved protocol. Session logs will 
be monitored weekly by the project coordinator and the PI (as noted above). After 
documenting the AE/SAE/protocol exception on the session log, staff members will be 
required to complete an AE/SAE/protocol exception survey using the study’s REDCap on- 
line documentation tool. The survey tool will prompt for all required reporting information. 
The PI (or her designate) will follow up on all AEs/SAEs by calling or emailing the 
participant within 24 hours. The PI (or her designate) will follow up with staff members 
regarding all protocol exception reports within 48 hours. Follow-up steps will also be 
documented in REDCap. Compliance to these steps will be monitored as part of weekly 
monitoring procedures. 
 
The PI (or her designated proxy) will generate reports on the following schedule: 
 
• 
Anticipated SAE reported within 48 hours of study’s knowledge to the IRB, with 
the exception that all deaths will be reported within 24 hours of study’s 
knowledge. 
• 
Unanticipated SAE reported within 48 hours of study’s knowledge to the IRB. 
• 
All protocol exceptions will be reported to Northwestern University’s IRB (using 
IRB approved processes) within 7 days. 

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Summary report of all other AEs/SAEs/protocol exceptions annually to the NIH Program 
Officer unless requested at a higher frequency. 
 
Conditions where the research team may intervene. Referrals made to outside resources 
as a result of information discovered during the study (e.g., hearing loss, elevated 
depression screening scores) will be documented. Each case will be reviewed by the 
Participants will be provided written documentation of the concern and will be encouraged 
to follow up with their health care practitioner for further referrals. 
 
If a study team member determines that the study protocol (neuropsychological testing or 
discourse sampling) is too distressing for the participant (e.g., excessive crying, fatigue 
that is not recoverable following a break/rest) then the protocol will be terminated. 
 
Suicidal Ideation Plan. Items on measures of depression (GDS) will be reviewed by 
research staff at the time of data collection for any indicators of suicidal ideations. If the 
participant screens positive for depression and/or self-identifies suicidal ideations during 
these measures (or at any time during the protocol), the PI (or her designate) and the 
study medical doctor (Collaborator: Simuni) will be notified immediately to determine 
appropriate follow-up (> 10 on the GDS). Before leaving the study visit, all participants 
failing the depression screen will be encouraged to contact their family physician and will 
be provided with a list of mental health resources (see attached). 
 
18.0 Data, and if applicable, Specimen Banking: 
All raw datasets will be archived for a minimum duration of seven years after the 
completion of this project but will likely be archived for public access indefinitely through 
the Inter-University Consortium for Political and Social Research (ICPSR) at the 
University of Michigan. Data location and access procedures will be made available in 
any publications and presentations that are authored or co-authored by key 
investigators. Most data (video/audio data are exceptions) are collected and stored in 
de-identified formats. That is, no information regarding participant's identity is stored 
along with datasets. Each participant is assigned a participation code and demographic 
information is linked to the code, but the code is not linked to any personally identifying 
information. 
 
For the audio/video recordings of the neuropsychological testing and spoken discourse 
samples, de-identification through masking the identity of participants’ voices would 
impact negatively on data analyses. For this reason, these data will not be shared or 
archived in a public database. They will remain stored on the PI’s server for a minimum 
of 7-years. 
 
Analyzed orthographic transcripts and summary data from the spoken discourse 
samples will be made available through the NIH-funded data repository. 
 
Summary data and individual item responses for the neuropsychological measures will 
be archived for researcher access. However, actual copies (i.e., pdfs or images) of the 
test forms cannot be made available due to publishers’ copyright restrictions. 
 
We will document all data files using standardized, high-fidelity methods to increase 
efficiencies in accessing archived data and in data sharing. We will use the ICPSR 

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Guide to Archiving, which defines industry standards for data archiving documentation 
(http://www.icpsr.umich.edu/icpsrweb/content/deposit/guide/), to thoroughly document all 
data files and meet data archiving standards. 
 
19.0 Data Sharing: 
Data associated with the proposed research project will be shared by depositing these 
data at the Inter-University Consortium for Political and Social Research (ICPSR) at the 
University of Michigan, which is an NIH-funded repository. Data documentation and de- 
identified data will be deposited for sharing, along with participant demographics, 
consistent with applicable laws and regulations. Summary data suitable for meta-analysis 
and associated secondary analysis of data (if any), along with data content, format, and 
organization, will be available at ICPSR. Submitted data will conform to relevant data and 
terminology standards. Data will be deposited into the ICPSR repository as soon as 
possible after the end of the 3-year project period, but no later than 24 months following 
the completion of the funded project period or upon acceptance of the data for publication, 
whichever is earlier. 
 
Requests for accessing these data will require approval by the PI (or her designate) 
through the ICPSR. Requests will only be granted to individuals with IRB or similar agency 
approval indicating that the requesting research has met all ethical requirements. Only 
de-identified data will be made available to others. Audio/video recordings will not be 
shared. 
 
20.0 Qualifications of Research Team to Conduct the Research: 
The PI has a full-time tenure appointment with 40% dedicated research time. The PI is a 
trained speech-language pathologist with extensive experience working with the 
populations under study. Additionally, a part time research coordinator who is also a 
speech-language pathologist will be hired as part of the project budget. The graduate 
students who will be working with the project also has extensive experience with this 
population by virtue of lab training. The PI and Collaborator Cherney are both well 
versed in the procedures used in the protocol (akin to typical clinical procedures), 
recording methods, and also facilitating communication with adults who have cognitive 
impairment. The procedures for facilitating consent (described earlier in the document) 
are well within Dr. Roberts’ clinical skill set. The analyses proposed are clinical 
measures used commonly in Dr. Roberts’ and Dr. Cherney’s research. Collaborator 
Simuni is a medical physician with expertise in Parkinson’s disease and will provide 
clinical support to the study protocol.