Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia 3.0 Pilot
Phase: NA
Conditions: Aphasia, Primary Progressive Aphasia, Dementia, Communication, Alzheimer Disease
Sponsor: University of Chicago

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CB3 Pilot (Communication Bridge: A Person-centered Internet-based Intervention for 
Individuals With Primary Progressive Aphasia)
NCT: NCT05697380 
Date: 8.6.24 

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STUDY TITLE: 
Communication Bridge: A multicomponent person-centered Internet-based 
intervention for individuals with primary progressive aphasia 
PRINCIPAL INVESTIGATOR: 
Name: 
Department: 
Emily Rogalski, PhD. 
Mesulam Center for Cognitive Neurology & Alzheimer’s 
Disease 
CO-INVESTIGATORS: 
Name: 
Department: 
Darby Morhardt, PhD 
Mesulam Center for Cognitive Neurology & Alzheimer’s 
Disease 
Sandra Weintraub, PhD Mesulam Center for Cognitive Neurology & Alzheimer’s 
Disease 
Marek-Marsel 
Mesulam, MD 
Mesulam Center for Cognitive Neurology & Alzheimer’s 
Disease 
Alfred Rademaker, 
PhD 
Preventive Medicine 
Angela Roberts, PhD 
Communication Sciences and Disorders 
Aimee Mooney, MS, 
CCC-SLP
Oregon Health and Sciences University 
Melanie Fried-Oken, 
PhD 
Oregon Health and Sciences University 
VERSION DATE: May 31, 2022 
RELATED STUDIES: 
•
STU00206086: Communication Bridge: A person-centered Internet-based
intervention for individuals with primary progressive aphasia.
1) This study will extend the STU00206086 protocol for up to 30 participants
and their communication partners who completed, were screened for, were
placed on the waitlist for, or new persons meeting the eligibility criteria
for the study. The objective is to evaluate the effectiveness of evidence- 
based interventions on individuals living with PPA and their ability to
communicate after treatment, but for a longer duration of time (3 session
blocks over ~18-months, see figure and detailed description below) in
order to examine further stages of the disease.

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Check any applicable boxes in the table below – you will be asked for 
further detail on these topics later in the protocol form: 
Indicate Vulnerable 
Population(s) to be Enrolled 
☐Children (you must complete Appendix A in addition
to this protocol document if you plan to enroll children)
☒Cognitively Impaired Adults
☐Pregnant Women (IF the research activities will affect
the pregnancy or the fetus)
☐Prisoners (or other detained/paroled individuals)
International Research 
(check this box if you will 
collect data from 
individuals located outside 
the United States) 
☒ 
Research involving external 
collaborators (some 
research activities will be 
carried out by individuals 
not employed by 
Northwestern or NU 
affiliates) 
☒ 
Research has U.S. Federal 
government funding via 
direct award or a sub-award 
(e.g., NIH, NSF, other 
federal agencies or 
departments) 
☐ 
1.0 
Purpose and rationale of the study: 
The purpose of this study is to evaluate the effectiveness and feasibility of evidence- 
based interventions in individuals living with primary progressive aphasia (PPA) that 
address communication-focused outcomes. By extending the intervention to include 
social work our aim is to address psychosocial and communication concerns that may 
have emerged as a result of their progressive neurodegenerative condition, and/or 
potentially slow the inevitable decline of functional communication that occurs as a 
consequence of PPA. The study will enroll individuals who have completed, were 
screened for, were placed on the waitlist for, or new persons meeting the eligibility 
criteria for the related study, STU00206086, to understand the added benefit of adding 
social work to the intervention. The intervention will be provided remotely by speech- 
language pathologists and social workers using a HIPAA compliant Zoom license, 
provided by Northwestern University. This study will be a continuation of one of the 
largest non-pharmacologic intervention studies for individuals with PPA to date. It will 
add critical information regarding the effectiveness of telepractice interventions for 
communication disorders in adults with primary progressive aphasia specifically, and in 

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dementia more broadly. The information gained will be especially important for 
understanding the psychosocial needs of individuals and in different stages of the disease, 
a topic that is currently not covered in research. 
Aim: Understand the added benefit and feasibility of multicomponent (speech-language 
therapy and social work) intervention for individuals who have completed, were screened 
for, were placed on the waitlist for, or new persons meeting the eligibility criteria for the 
related study, STU00206086 
Background: 
Primary Progressive Aphasia. The diagnosis of primary progressive aphasia (PPA) is 
made when a relatively isolated and progressive impairment of language that occurs as a 
result of a neurodegenerative disease process1. It is associated with Alzheimer’s disease 
and/or a form of frontotemporal lobar degeneration. Adults with PPA can have deficits in 
word finding, word usage, word comprehension, and/or grammar, among other language 
impairments. Consensus research criteria recognize three variants of PPA based on the 
profile of language deficits: agrammatic (PPA-G), semantic (PPA-S) and logopenic 
(PPA-L)2. 
Speech and language intervention for language impairments associated with PPA. 
Promising case-reports and small group studies of non-pharmacological communication 
interventions in PPA show positive effects of impairment-based and participation-based 
interventions (i.e., script training to improve fluency, multi-syllabic word production 
training to improve articulation; for reviews see9-11). However, with few exceptions (our 
current RCT) there are no gold-standard randomized control trials, which limits the 
ability to move this research into mainstream clinical implementation. Importantly, few 
studies have extended intervention and data collection beyond a 6-to-12-month window 
or included social work, and none have done so at the group level. As such the longer- 
term benefits of extended multi-component interventions on maintaining communication 
abilities, preserving participation in functional communication activities, and slowing 
language impairment progression remain unexamined. We will address this concern by 
enrolling a subset of consenting participants into a multi-component intervention to 
examine whether we are able to address both functional and psychosocial needs of the 
individuals living with PPA. 
Telepractice model. Access to services and the ability to conduct large evidence-based 
studies has been limited because individuals with PPA may not live near an SLP who has 
experience in treating individuals with neurodegenerative aphasia15. In fact, >40% of the 
participants in our preliminary Communication Bridge study lived in rural areas and 
>94% lived outside Chicago, IL, the home site for the study. Distance from a healthcare
facility is one of many variables that can be alleviated using a telepractice model. The
intervention in this protocol will be deployed via a telehealth service delivery approach.
This is consistent with our in-progress Phase-2, 12-month, study and also our pilot
study16. To date, 33 people have completed our 12-month study using our
Communication Bridge web-based portal and a video-conferencing platform without any
significant issues or concerns.

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Social work component. In this protocol, we augment the intervention provided in our 
base 12-month protocol by adding a social work component alongside the speech- 
language pathology intervention. The combined, multi-disciplinary intervention approach 
is designed to address the psychosocial impairments that may interact with language 
impairments to negatively impact communication outcomes in individuals with PPA. 
Individuals with PPA tend to have preserved insight into their disease, which may 
contribute to increased risk for depression3. Onset of PPA tends to be before the age of 
65, which is younger than those with amnestic Alzheimer’s dementia4. This creates 
unique psychosocial and economic challenges since adults with PPA are commonly in the 
prime-earning phase of their careers and often have dependent children at home5. Social 
workers can help families navigate the difficult decisions related to their diagnosis. Here 
we will provide a multi-component intervention to examine whether we are able to 
address both functional and psychosocial needs of the individuals living with PPA. 
2.0 
Enrollment Criteria (who can be in your study and who would not 
be eligible to participate in your study): 
Must have completed, were screened for, were placed on the waitlist for, or new 
persons meeting the eligibility criteria for the related study STU00206086 within the 
last 24 months and maintain eligibility criteria: 
•
Must speak English as their primary language and have sufficient proficiency in
English for completing all assessment and treatment activities
•
Hearing adequate to have a conversation in a crowded room (correction
permitted)
•
Reported vision adequate to read the newspaper (correction permitted)
•
Must have a communication partner (spouse, family member, close friend) who is
willing to participate in the study
•
Adequate experience with computers
•
Diagnosis of PPA must be made by a clinician
•
Must be 18 years or older
•
Must have the ability to consent
3.0 
Sample Size: 
Up to 30 individuals with PPA and their communication partners (spouse, family 
member, or close friend) will be enrolled. A formal sample size estimate and power 
analysis was not completed as this is a feasibility study to examine the added benefit of 
extended multi-component treatment for persons with PPA. Data from this Phase I 
expansion of our current Phase II trial will be used to establish feasibility of the protocol, 
to make protocol adjustments, and to collect preliminary effectiveness data for an 
upcoming grant submission. 
4.0 
Recruitment and Screening Methods: 
This study will only recruit participants from four routes: 

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- Participants completed the related study (STU00206086). When they consented
to that study, they selected “I agree” to be contacted for future studies.
- Participants were screened for the related study (STU00206086) and were not
eligible to participate and voluntarily signed up for the Mesulam Center Research
Registry (which could have occurred before or after they were screened). The
Mesulam Center Recruitment Registry is housed within the Alzheimer’s Disease
Core Center IRB-approved protocol (STU00023196). Participants residing in the
European Economic Area will not be contacted for this study. There will be no
external recruitment strategies needed. Potential participants will be contacted by
the study team, with whom they already have an established relationship.
Participants will be emailed the initial recruitment script (see supporting
document) and asked if they would like to enroll in this study.
- Participants were placed on the waitlist for the related study (STU00206086)
due to the high volume of interest and limited enrollment capacity. All
participants were added to the waitlist after voluntarily signing up for the
Mesulam Center Research Registry. Individuals who were seen at NMH’s
Neurobehavior and Memory Clinic will have a HIPAA authorization in their
consent form to grant approved study team members access to their medical
records through an Enterprise Data Warehouse (EDW) exception. Individuals
who were not seen at NMH will be asked to send in their own medical records
and will not require a HIPAA authorization. We will verify these individuals as
meeting eligibility criteria through medical records and a brief screening by our
team.
- New persons meeting eligibility criteria for the related study (STU00206086)
who contacted the study team after enrollment closed. Individuals who were seen
at NMH’s Neurobehavior and Memory Clinic will have a HIPAA authorization in
their consent form to grant approved study team members access to their medical
records through an Enterprise Data Warehouse (EDW) exception. Individuals
who were not seen at NMH will be asked to send in their own medical records
and will not require a HIPAA authorization. We will verify these individuals as
meeting eligibility criteria through medical records and a brief screening by our
team
If the participant is interested, a screening call will occur over phone or video-chat. 
During this interest call, a study team member will complete a brief screening discussion 
(see supporting document) to assess whether the participant has experienced any 
significant life or medical changes since being screened for or completing STU00206086 
that affect eligibility. A summary of this conversation will be stored in the REDCap 
project. 
5.0 
Research Locations: 
The research team will be located at the Mesulam Center for Cognitive Neurology and 
Alzheimer’s Disease. Speech language pathologists and social workers that provide 
treatment for the study will come from Northwestern University and Oregon Health and 
Science University. 

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All research and data collection visits will take place online over a HIPAA-compliant 
Zoom software. This study does not require any in-person visits. The potential 
participants who will enroll in this study come from all over the United States or 
international countries, excluding the European Economic Area, and will connect to the 
study visits from their home. 
6.0 
Multi-site Research (research that involves external collaborating 
institutions and individuals): 
The individuals from OHSU are clinicians on the current study. However, all hard copies 
of data and coordination for the study will take place at NU. Enrollment decisions will be 
made by the team at NU and participants will be assigned to one of the clinicians. All 
recruitment, enrollment, and consenting procedures take place at NU. We are using these 
clinicians because they are experts in treating individuals with primary progressive 
aphasia, which is rare. 
The researchers joining us from OHSU are Aimee Mooney, M.S., CCC-SLP, speech- 
pathologist and Melanie Fried-Oken, PhD. Both researchers are listed as Co- 
Investigators. Aimee Mooney will be seeing participants as a treating clinician. Dr. Fried- 
Oken will not see participants for the study but will play an advisory role and have access 
to participant data. An IAA has been established between Northwestern University and 
OHSU. Northwestern University will serve as the IRB of Record. 
7.0 
International Research (where data collection will occur outside 
the United States and U.S. territories, including online activities) 
International participants, excluding those from the European Economic Area, may be 
enrolled if they meet all eligibility criteria, including using English as their primary 
language. Similar to domestic participants, international participants will join all study 
visits using the iPad provided for them. All data collection will take place from 
Northwestern University and our approved collaborator at OHSU. An external IRB 
review will not be obtained since Northwestern will remain the primary study site. In 
accordance with Northwestern’s policy, the Institution’s human research activities, 
regardless of whether the research is subject to the U.S. Federal Policy for the Protection 
of Human Subjects, will be guided by an assurance of specific principles governing the 
institution in carrying out its responsibilities for protecting the rights and welfare of 
humans in research conducted at or sponsored by the institution. 
8.0 
Procedures Involved: 
Eligible participants will be enrolled in this study for up to 18 months. Blocks 1 and 2 
will last about 3 months each, with an approximately 4-month break between each block. 
After Block 2, there will be an approximately 4-month break. Block 3 will last about 1 
month. 
Participants will be mailed an Apple iPad, Apple Smart Keyboard, and Apple Pencil to 
keep for the duration of the study. The study team will use secure tablet shipping boxes 
through FedEx to deliver and track shipments. The Apple equipment will be used to 

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connect for study visits and to complete home exercises assigned during the study. When 
the participant has completed the study, they will be a sent a FedEx shipping label to 
return the Apple equipment in the box they were originally shipped in. 
Orientation and Training 
Participants and communication partners will receive an orientation to the technological 
aspects of the study. During this session, both the participant and the communication 
partner will be consented to the study, provide updated demographic and health 
information, and learn the technological components of the iPad and study web 
application. This web-application is the main resource for the study and is where 
individuals access their therapy sessions, instructional videos and resources, and 
interactive web exercises. 
After the orientation, participants and communication partners will go through a series of 
Blocks. In Blocks 1 and 2, there will be a pre- and post-evaluation, consisting of a series 
of neuropsychological measures and/or questionnaires. Blocks 1 and 2 will contain 5 
therapy sessions and 2 social work sessions. Block 3 will consist of an evaluation with 
neuropsychological measures and questionnaires followed by three discharge sessions. 
The battery may be reduced at any timepoint based on the study team judgment of 
participant burden and ability. Neuropsychological measures will require at least a 6- 
month gap between administration. 
1) Neuropsychological Testing. Participants with PPA will complete
neuropsychological tests relevant for assessing cognition with a particular focus on
language abilities for individuals with primary progressive aphasia. Administered by a
research coordinator. See appendix.
2) Questionnaires. A research coordinator will administer the questionnaires to the
participant at the neuropsychological testing session. The communication partner may
assist the participant with PPA in completing the questionnaires if needed. The
communication partner will also fill out self-report questionnaires  including
measures of communication/behavioral/cognitive abilities of the individual with a
diagnosis and estimates of caregiver burden. Assistance will be provided from the
study team as requested. See appendix.

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3) Speech-Language Pathology (SLP) Evaluation. At this evaluation, the SLP will
complete several assessments for assessing language abilities for individuals with
primary progressive aphasia. They will also discuss personal goals (participant and
communication partner), current challenges related to their diagnosis, and therapy
expectations. See appendix.
4) Speech-Language Pathology (SLP) Therapy Sessions. Sessions are approximately 1
hour long. The sessions will be composed of impairment-based strategies (e.g., script
training and training of target-words), compensatory-based strategies, and other related
strategies and tasks as deemed appropriate by the SLP. The SLP, the participant with
PPA, and the communication partner will collaboratively identify the most appropriate
strategies to focus on based on other evidence-based therapy approaches (conversation
strategies, impairment-based strategies, compensatory strategies). During therapy
sessions, the communication partner is engaging as a co-participant in the intervention.
5) Social Work Sessions. Sessions are approximately 1 hour long. The first session will
include an in-depth psychosocial assessment with the participant and their
communication partner. Areas of discussion will include how the participant and family
are coping with PPA symptoms and changing roles, their understanding of the diagnosis,
the health of their family relationships along with emotional, social and financial
resources, overall strengths and challenges and the need for community services. The
participant, family and social worker will work collaboratively to identify needs and
tailor plans for future sessions to address the most concerning identified needs.
9.0 
Research with Vulnerable Populations 
Vulnerable Populations: Individuals with Primary Progressive Aphasia are cognitively 
impaired. However, individuals in the mild stages of Primary Progressive Aphasia have 
deficits primarily in the use of language. Memory, attention, and other cognitive abilities 
are preserved. When the individuals enrolled or were screened in the related study, they 
were verified as being in the mild stages of the disease through medical records and a 
brief evaluation by our team. Although some disease progression is expected, we 
anticipate (based on more than 15 years of working with this population) participants will 
be able to understand and complete the consent process. We will gather medical records 
and conduct a screening for the individuals placed on the waitlist and new persons who 
contacted the study team after enrollment closed for the related study to determine 
eligibility. To aid with comprehension, participants with PPA will be consented with their 
communication partner. Their communication partner will also be consented into the 
study. This study provides an intervention for a population that has no pharmacological 
treatment for their disease, and thus a benefit for them to more effectively cope with their 
symptoms. 
Individuals will be provided with the opportunity to speak with members of the study 
team, including speech-language pathologists, prior to consent and enrollment to ask any 

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questions they have. The study team members, including SLPs and social workers, are 
trained in communicating with individuals of this population. 
To confirm that participants have the ability to provide their own consent, individuals 
with PPA will complete a consent assessment task with the research coordinator after 
reviewing the consent from. The task will prompt the participant to respond, either 
verbally or by pointing, to yes or no questions regarding information discussed in the 
consent form. If nonverbal answers are provided, the communication partner will aid in 
relaying the participant’s gestural answers. During this task, the research coordinator may 
need to provide clarification on any areas of confusion. This assessment task will provide 
documentation of the participant’s understanding and consent (see supporting 
documents). The assessment task template is based on a task used in the ACT NOW 
international clinical trial (NCT00831740). 
During the first visit of Block 2 and Block 3, the research coordinator will confirm 
participants; understanding of their involvement in a research study. The research 
coordinator will complete the consent confirmation task (see supporting document) and 
document PT’s decision. If the participant expresses confusion, the research coordinator 
will re-administer the consent assessment task and provide any clarification needed. The 
consent confirmation task and updated consent assessment task, if needed, will be stored 
in the participant’s study file on FSMresfiles. 
10.0 Incomplete Disclosure or Deception: 
N/A 
11.0 Consent Process: 
Both participants (individuals with PPA and their communication partners) will be 
consented verbally over video-chat with a research coordinator. The consent forms will 
be housed within REDCap. There will be two separate consent forms for individuals with 
a PPA diagnosis. Participants who were seen at NMH’s Neurobehavior and Memory 
Clinic will have a HIPAA authorization in their consent form to grant approved study 
team members access to their medical records through an Enterprise Data Warehouse 
(EDW) exception. Participants who were not seen at NMH will be asked to send in their 
own medical records and will not require a HIPAA authorization. Participant consent 
forms that contain HIPAA authorizations must be retained for at least 6 years after 
completion of the study. 
During this video-chat consent, participants will have the study explained to them in 
detail and they will have ample time to ask for questions or clarifications. A research 
coordinator will go through the REDCap consent (sent via link to the participant) with the 
participants. After reviewing the forms, the research coordinator will administer the 
consent assessment task to ensure the person with PPA’s understanding and consent to 
participate. The participants will electronically sign the consent forms. Participants will 
be emailed their signed informed consent from REDCap after completion of the form. 

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Participants (individuals with PPA and their communication partners) will be asked to 
consent to an optional element on the consent form that asks if they would be willing to 
allow their audio and/or video recordings from sessions to be used in scholarly 
presentations or publications. These recordings could potentially be shown at disease- 
related conferences and speech-language pathology professional conferences in order to 
help professionals in the field understand the research and/or aid in training purposes. 
Because of the unique and rare presentation of PPA, speech samples and/or video 
recordings that display the effortful motor movements in producing words are often the 
best way to convey how the disease presents itself. In order to thoroughly explain our 
research methods and describe the speech therapy strategies used, it will be most 
beneficial to provide audio and/or video recordings during presentations to explain what 
written or verbal text cannot accomplish. If the participant answers “I agree,” he or she is 
indicating they understand the risks associated with identification. 
Participants (individuals with PPA and their communication partners) will complete an 
optional section on the consent forms that asks if they will allow their identifiable data to 
be shared with Mesulam Center faculty, staff, students, or approved collaborators for use 
in future studies. Participants will initial whether they agree or disagree on the REDCap 
form via the electronic signature function in REDCap. 
Participants (individuals with PPA and their communication partners) will complete an 
optional section on the consent forms that asks if the PI can contact them in the future to 
see if they are interested in participating in other research studies by the PI. Participants 
will initial whether they agree or disagree on the REDCap form via the electronic 
signature function in REDCap. 
12.0 Waiver of Participant Signature on Consent Form: 
N/A 
13.0 Waivers and Alterations of Consent Information: 
N/A 
14.0 Financial Compensation: 
N/A 
15.0 Audio/Video Recording/Photography 
All study visits will take place online through a HIPAA-compliant Zoom license, 
provided by Northwestern for the Communication Bridge email account. All visits will 
be audio and video recorded for internal data collection purposes. The recordings are 
essential for data collection and analysis. Due to the language impairments present in 
PPA, participants and SLPs often communicate through nonverbal language (i.e., 
gestures, typed visual aids) during study visits. The therapy tasks being completed 
require us to watch visual indicators during data analysis. The data are used for 
intervention fidelity assessments that are conducted over the duration of the protocol. The 

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audio and video recordings are used to verify responses to uphold data rigor and integrity. 
Additionally, the recordings are used for continuous trainings of study personnel. 
Participants and communication partners must consent to have their audio and video 
recorded for data collection purposes to participate in this study. There is an optional 
element in the consent form asking participants for permission to use audio and/or video 
recordings for use in scholarly presentations or publications. 
All video files will be stored on FSMresfiles on locked computers and will be coded by 
study identity. Video recordings will not be saved to the Zoom cloud. The recordings 
themselves will not be deidentified. Portions of the recordings will be transcribed in order 
to complete therapy tasks and fulfill data collection (i.e., speech therapy strategies that 
incorporate script training and scoring). These transcriptions will be coded by study 
identity and stored on FSMresfiles. Only the PI and approved study personnel will be 
able to access these files. Recordings will be saved for as long as may be necessary to 
protect any intellectual property resulting from the work. 
16.0 Potential Benefits of this Research: 
By participating in this study, participants will learn new strategies for coping with their 
communication difficulties caused by the disease. These strategies may allow the 
individuals to engage more actively in their lives by facilitating communication. Due to 
the progressive nature of the disease, individual’s communication will get worse over 
time and is known to impact psychosocial wellbeing of families. This current study is 
important in determining the duration of potential benefits of a multi-component 
intervention beyond the speech language therapy intervention studied in the related 
protocol. 
Information learned in this research will provide valuable knowledge for the speech 
therapy community regarding treatment for moderate to late stages of PPA. 
17.0 Potential Risks to Participants: 
The risks for participation in the proposed research are minimal. Potential adverse events 
associated with this research include: 
1. Loss of confidentiality
2. Fatigue and/or frustration in performing the online intervention
3. Depression and Anxiety: Caregivers of individuals with PPA and living with
PPA can both be psychologically taxing experiences. It is not abnormal for
individuals in these circumstances to express negative emotions, including
hopelessness, sadness, anger, or frustration. It is important to recognize when
these symptoms go beyond what is normally expected.
These risks will be minimized in the following ways: 
1. Data will be stored securely, and any data sharing agreements will adhere to
NU’s strict policies on privacy protection.

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2. This risk of fatigue is considered to be minimal and is addressed in the
consent form. Fatigue will be minimized by advising the participant and
caregiver that they should rest if they feel fatigued, before continuing with any
component of the intervention. Participants will be working with licensed
speech-language pathologists who are trained to identify fatigue and
frustration and they will modify the plan accordingly. Participants will be
informed of this risk when consenting to join the study.
3. The risk of depression and anxiety is considered to be minimal. Depression
and Anxiety measures are completed with both the participant and
communication partner at every evaluation. Specifically, the CAT-version of
the PROMIS Depression and Anxiety Sub-tests are given to participants and
communication partners (Cella et al., 2010). If the measures reveal a clinically
relevant level of anxiety or depression (based on normative values), the
research team will follow a risk-specific protocol outlined in the Risk
Identification and Response Plan. The Risk Identification and Response Plan
identifies unanticipated risks that go beyond what is expected in this study.
However, if any verbal/behavioral indication of suicidal/homicidal thoughts
are observed by the speech-language pathologists in the study, measures will
be taken to alert the appropriate people. A licensed clinical social worker,
Darby Morhardt, Ph.D., is a Co-Investigator on this study. She will be
consulted according to the plan and will meet with our participants for a
session. Since Dr. Morhardt is a member of the study team, this information
will be kept with the participant records.
18.0 Provisions to Protect Participant Privacy and Data 
Confidentiality: 
All of the data and materials collected are for research purposes only, and data will be 
kept in strict confidence. No information will be given to anyone without permission 
from the participants.  The consent form includes the informed consent statement 
required by the IRB of NU for clinical studies of cognition. The consent form will 
explain that only the PI and approved study personnel will have access to medical records 
and personal identifiable information. Participants will be given the opportunity to ask 
questions and will be provided with a signed copy of their consent form. All data 
collection will occur over a HIPAA-compliant Zoom software. Participants will be given 
a unique meeting ID for each study visit that only study personnel will have access to. 
Medical records will be sent to the study team by the participants, if they are not seen by 
a doctor affiliated with Northwestern Memorial Hospital. Participants who were seen at 
NMH will consent to have their medical records shared with the study team for review by 
completing the HIPAA Authorization on the consent form. No one outside the PI or study 
team will have access to the medical records. 
Data will be collected, entered, and stored securely in REDCap (Research Electronic 
Data Capture) database using the subject ID number. REDCap is a secure, web-based 
application for building and managing online data capture for research studies. Data will 
be de-identified through the use of the assigned study ID number and entered into the 

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password protected REDCap database within 48 hours of collection. All participant data 
are checked for accuracy. Data are maintained in a format that is easily transferred to 
statistical software for analysis. The database will be password protected and accessible 
only to the principal investigator and study personnel. Paper copies of any measures will 
be kept in locked files in our research offices and will only be accessible to the PI and 
study personnel. Northwestern University is a member of the REDCap consortium and 
the services are made available for this project through our CTSA-funded NUCATS 
Institute. 
Data from the web-application will be constructed using an industry-standard software 
platform (PostgresSQL, Ruby on Rails, Apache, Linux). Data obtained through the web- 
application infrastructure will be stored and managed by Table XI, a product 
development and software consultant firm, and will be protected via IP restriction and on 
a Virtual Private Network accessible only to study-authorized staff. Data from the web- 
application will be stored using the participant’s study ID number. Performance data 
from the web-application (e.g., Picture Cards accuracy) can be downloaded according to 
the participant study ID by the PI or approved study personnel into files that are easily 
used for data analysis (e.g., .csv, .xls). All access to this application will be provided 
over encrypted-TLS communication and all servers are locked and managed in a 
physically secure facility with Marlok identity management. 
19.0 Data Monitoring Plan to Ensure the Safety of Participants: 
An adverse event (AE) is any untoward medical occurrence in a participant during 
participation in the clinical study that is attributed to the cognitive testing or the 
engagement in the online therapy intervention. An adverse finding can include a sign, 
symptom, abnormal assessment, or any combination of these. While all adverse events 
will be reported, some may be expected due to the participant’s medical condition. Each 
adverse event will be classified as being attributable or not to participation in the study. 
A serious adverse event (SAE) is any AE that results in one or more of the following 
outcomes that are attributable to participation in the study: 
·
Death
·
A life-threatening event
·
Inpatient hospitalization or prolongation of existing hospitalization
·
An important medical event based upon appropriate medical judgment
Grading Scale: AEs will be labeled according to severity, which is based on their impact 
on the participant. An AE will be termed “mild” if it does not have a major impact on the 
participant, “moderate” if it causes the participant some minor inconvenience, and 
“severe” if it causes a substantial disruption to the participant’s well-being. 
Study Relatedness Criteria: AEs will be categorized according to the likelihood that they 
are related to the study intervention. Specifically, they will be labeled definitely 
unrelated, definitely related, possibly related, or probably related to the study 
intervention. 

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Reporting and Follow Up: AEs will be reported by severity, relatedness to the 
intervention, action taken and outcome. Each adverse event will be reported separately. 
All AE reports and annual summaries will be de-identified and will not include 
participant-identifiable material. The PI will engage in continuous close monitoring of 
research participants with reporting of AEs to the Northwestern University Institutional 
Review Board. 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be 
reported to Northwestern University’s IRB within 24 hours of notification of its 
occurrence. 
20.0 Long-term Data and Specimen Storage and Sharing: 
Data collected from this study will be stored for at least the minimum requirement of 
three-years after study completion. Per Northwestern’s policy on Research Data: 
Ownership, Retention, and Access, research data from this study may be kept for as long 
as may be necessary to protect any intellectual property resulting from the work. Data 
will be stored in locked files in our research offices as well as on FSMresfiles. 
21.0 Qualifications of Research Team to Conduct the Research: 
All study team members are CITI trained. 
Speech-Language Pathologists (SLPs): SLPs have completed a two-year Master's 
program in Speech-Language Pathology and hold a current Certificate of Clinical 
Competence (CCC) issued by the American Speech-Language-Hearing Association 
(ASHA). 
Social Workers: Social workers must have completed a Master’s program in Social Work 
and must be a Licensed Clinical Social Worker (LCSW) or Licensed Social Worker 
(LSW) in the State of Illinois. 
Research Staff: All staff members go through a rigorous training protocol before 
performing study visits. This includes observing others team members perform data 
collection, studying the protocol and standards of procedures, and being observed by 
senior team members until approved to work solo. 
References 
1. 
Mesulam MM, Rogalski EJ, Wieneke C, Hurley RS, Geula C, Bigio EH, Thompson
CK, Weintraub S. Primary progressive aphasia and the evolving neurology of the
language network. Nat Rev Neurol. 2014;10:554-569
2. 
Gorno-Tempini ML, Hillis AE, Weintraub S, Kertesz A, Mendez M, Cappa SF, Ogar
JM, Rohrer JD, Black S, Boeve BF, Manes F, Dronkers NF, Vandenberghe R,
Rascovsky K, Patterson K, Miller BL, Knopman DS, Hodges JR, Mesulam MM,
Grossman M. Classification of primary progressive aphasia and its variants.
Neurology. 2011;76:1006-1014

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3. 
Medina J, Weintraub S. Depression in primary progressive aphasia. J Geriatr
Psychiatry Neurol. 2007;20:153-160
4. 
Mesulam MM. Primary Progressive Aphasia: A Language-Based Dementia. The
New England Journal of Medicine. 2003;349:1535-1542
5. 
Nickels L, Croot K. Understanding and living with primary progressive aphasia:
Current progress and challenges for the future. Aphasiology. 2014;28:885-899
6. 
Boxer AL, Lipton AM, Womack K, Merrilees J, Neuhaus J, Pavlic D, Gandhi A, Red
D, Martin-Cook K, Svetlik D, Miller BL. An open-label study of memantine
treatment in 3 subtypes of frontotemporal lobar degeneration. Alzheimer Dis Assoc
Disord. 2009;23:211-217
7. 
Johnson NA, Rademaker A, Weintraub S, Gitelman D, Wienecke C, Mesulam M.
Pilot trial of memantine in primary progressive aphasia. Alzheimer Dis Assoc Disord.
2010;24:308
8. 
Reed DA, Johnson NA, Thompson C, Weintraub S, Mesulam MM. A clinical trial of
bromocriptine for treatment of primary progressive aphasia. Ann Neurol.
2004;56:750
9. 
Farrajota L, Maruta C, Maroco J, Martins IP, Guerreiro M, de Mendonça A. Speech
therapy in primary progressive aphasia. Dementia and Geriatric Cognitive Disorders
EXTRA. 2012;2:321-331
10. Croot K, Nickels L, Laurence F, Manning M. Impairment- and activity/participation- 
directed interventions in progressive language impairment: Clinical and theoretical
issues. Aphasiology. 2009;23:125-160
11. Carthery-Goulart MT, da Silveira AdC, Machado TH, Mansur LL, Parente MdM,
Senaha MLH, Brucki S, Nitrini, R. Nonpharmacological interventions for cognitive
impairments following primary progressive aphasia. Dementia & Neuropsychologia.
2013;7:121-131
12. Bourgeois MS, Brush J, Elliot G, Kelly A. Join the Revolution: How Montessori for
Aging and Dementia can Change Long-Term Care Culture. Semin Speech Lang.
2015;36:209-214
13. Murray LL, Paek EJ. Behavioral/Nonpharmacological Approaches to Addressing
Cognitive-Linguistic Symptoms in Individuals With Dementia. Perspectives of the
ASHA Special Interest Groups. 2016;1:12-25
14. Cohen-Mansfield J, Jensen B, Resnick B, Norris M. Knowledge of and attitudes
toward nonpharmacological interventions for treatment of behavior symptoms
associated with dementia: a comparison of physicians, psychologists, and nurse
practitioners. Gerontologist. 2012;52:34-45
15. Douglas NF, Hinckley JJ, Haley WE, Andel R, Chisolm TH, Eddins AC. Perceptions
of speech-language pathologists linked to evidence-based practice use in skilled
nursing facilities. American journal of speech- language pathology / American
Speech-Language-Hearing Association. 2014;23:612-624
16. Rogalski EJ, Saxon M, McKenna H, Wieneke C, Rademaker A, Corden ME, Borio
K, Mesulam MM, Khayum B. Communication Bridge: A pilot feasibility study of
Internet-based speech–language therapy for individuals with progressive aphasia.
Alzheimer's & Dementia: Translational Research & Clinical Interventions.
2016;2:213-22
17. Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules.
Neurology. 1993;43:2412- 2414
18. Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for

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the staging of dementia. Br J Psychiatry. 1982;140:566-572 
19. Kertesz A. Western Aphasia Battery - Revised. Toronto, Ontario, Canada: Pearson
Canada Assessment Inc., 2006
20. Kaplan E, Goodglass H, Weintraub S. The Boston Naming Test. Philadelphia: Lea
and Febiger, 1983
21. Dunn L, Dunn D. Peabody Picture Vocabulary Test. Toronto, Onntario: Pearson
Canada Assessment Inc, 2006
22. Cherney LR, Babbitt EM, Semik P, Heinemann AW. Psychometric properties of the
communication Confidence Rating Scale for Aphasia (CCRSA): phase 1. Top Stroke
Rehabil. 2011;18:352-360
23. Baylor C, Oelke M, Bamer A, Hunsaker E, Off C, Wallace SE, Yorkston K.
Validating the communicative participation item bank (CPIB) for use with people
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24. Simmons-Mackie N, Kagan A, Victor JC, Carling-Rowland A, Mok A, Hoch JS,
Huijbregts M, Streiner DL. The assessment for living with aphasia: reliability and
construct validity. International journal of speech-language pathology. 2014;16:82-
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individuals with aphasia. Aphasiology 2005;19:435-450.
26. Schlosser RW. Goal attainment scaling as a clinical measurement technique in
communication disorders: a critical review. J Commun Disord 2004;37:217-239.
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Appendix 
This appendix contains a comprehensive list of all measures that may be used 
throughout the duration of the study. The battery may be reduced at any timepoint 
based on the study team judgment of participant burden and ability. 
Neuropsychological Measures 
1. Western Aphasia Battery
2. Rivermead Behavioral Memory Test – Version A
3. Mini-Mental Status Exam
4. Psycholinguistic Assessment of Language Processing in Aphasia – reading
subtest
5. Screen for Dysarthria and Apraxia of Speech – increasing word length
subtest
6. Boston Naming Test
7. Peabody Picture Vocabulary Test
8. Discourse Elicitation Tasks
9. Clinical Dementia Rating
Questionnaires for Participant 
1. Communication Confidence Rating Scale for Aphasia
2. Communication Participation Item Bank
3. Assessment for Living with PPA (reviewed with SLP)
4. PROMIS Depression – computer adaptive test
5. PROMIS Anxiety – computer adaptive test
Questionnaires for Communication Partner 
1. Neuropsychiatric Inventory Questionnaire
2. Montgomery Burden Interview
3. Health Utility Index
4. Revised Dyadic Adjustment Scale
5. Parent Adult-Child Relationship Questionnaire (Mother/Father)
6. Activities of Daily Living Questionnaire
7. Perception of Communication Index – Dementia of the Alzheimer’s Type
8. Communication Effectiveness Index

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9. PROMIS Depression – computer adaptive test
10. PROMIS Anxiety – computer adaptive test
SLP Measures 
1. Assessment for Living with PPA
2. Social Network Inventory – revised questionnaire
3. Progressive Aphasia Severity Scale