Primary Progressive AphasiaPhase 2CB3NCT06191198
Communication Bridge 3 Study
A Phase 2 study testing Communication Bridge™ and Evidence-Based Impairment Focused in people with Primary Progressive Aphasia, run by University of Chicago at 1 site in United States.
Trial summary
This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech-language therapy on communication abilities in individuals with… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Progressive Aphasia
- What is being tested?
- Communication Bridge™ and Evidence-Based Impairment Focused
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2024to 15 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records)
- English as primary language used in daily communication activities (by self-report)
- Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
- Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report)
- Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
- Geriatric Depression Scale score ≤ 9
Show all 11Show fewer
- Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery.
- 18+ years of age
- English as primary language used in daily communication activities (by self-report)
- Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
- Able to pass technology screening* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
Who cannot join
- A dementia diagnosis other than Primary Progressive Aphasia
- Participation is co-enrolled in an outside speech language therapy program during the study course.
- Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia)
- Medical records will be requested and reviewed to determine eligibility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago - American School Building
Chicago, Illinois, 60637
Matthew Bona, MPH, cbtrial@uchicago.edu
About this study
Official title: Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia
This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech-language therapy on communication abilities in individuals with PPA.
Read the detailed description
Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for approximately 17 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive up to 10 evaluations and 20 speech therapy sessions with a licensed speech therapist, as well as access to Communication Bridge, a personalized web application to practice home exercises that reinforce treatment strategies. There are no costs to participate in this study.
- Conditions
- Primary Progressive Aphasia
- Being tested
- Communication Bridge™, Evidence-Based Impairment Focused
- Keywords
- Aphasia, Dementia, Communication, Frontotemporal Dementia, Alzheimer Disease
- Medical subject headings
- Aphasia, Primary Progressive, Aphasia, Dementia, Communication, Frontotemporal Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Bridge™Behavioural
Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
Evidence-Based Impairment FocusedBehavioural
Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
| Study group | Role | What they receive |
|---|---|---|
| Communication Bridge™ | Experimental | Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. Receives: Behavioral: Communication Bridge™ |
| Evidence-Based Impairment Focused | Active comparator | The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants. Receives: Behavioral: Evidence-Based Impairment Focused |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Communication Participation Person Centered Goals
Goal Attainment Scaling, a 7-point rating scale with -3 representing 'no longer participating' and +3 representing 'exceeded goal'. Higher scores indicate better progress in goal achievement.
Measured: 5 assessment time points through study completion (up to 18 months)
Change in Communication Participation
The CPIB measure is a 10-item, disorder-generic, Likert scale that asks persons to rate how their condition interferes with participating in daily communication activities (e.g., talking to people you know/do not know, securing a turn in a fast-moving conversation). The psychometric properties of the measure have been published previously (Baylor et al., 2013; Baylor et al., 2019). Both raw and T-scores are available. The CPIB T-score has a theoretical mean of 50 and standard deviation of 10 with higher numbers reflecting higher levels of participation in communication activities.
Measured: 5 assessment time points through study completion (up to 18 months)
Montgomery Burden Inventory (MBI)
The MBI is a pen/paper Likert scale with 16 items distributed across three subscales (Montgomery et al., 1985) completed by the care partner. Total and mean item scores are calculated for each of the three subscales: Objective burden is defined as the perceived infringement of disruption of tangible aspects of a caregiver's life; Subjective demand/relational burden is typically described as the extent to which the caregiver perceives that the care recipient is overly demanding in the context of caregiving; Subjective stress burden is the emotional impact of caregiving responsibilities. Participants rate each item with a score between 1 (Not at all) and 5 (A great deal) corresponding to the amount of perceived burden. Higher scores reflect increased burden. Internal consistency .81 to .90. Construct validity demonstrated in mixed cohort of care partners of persons with dementia. Test-retest stability coefficients are robust (ICC of 0.92 to 0.91) (Farley et al., 2010).
Measured: 5 assessment time points through study completion (up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start23 Aug 2024
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive AphasiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- NIH Stage 2 behavioral clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Emily Roglaski, PhD, Principal investigator, Professor of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191198
- Sponsor's protocol ID
- IRB23-1175
- Other IDs
- 7R01AG055425-07
- Acronym
- CB3
- Status last verified
- May 2026
- First submitted
- 20 Dec 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT06191198
- Acronym / sponsor ID
- CB3 / IRB23-1175
- Conditions
- Primary Progressive Aphasia
- Keywords
- Aphasia, Dementia, Communication, Frontotemporal Dementia, Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Western University, Canada, National Institute on Aging (NIA)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech-language therapy on communication abilities in individuals with PPA.
Detailed description
Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for approximately 17 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive up to 10 evaluations and 20 speech therapy sessions with a licensed speech therapist, as well as access to Communication Bridge, a personalized web application to practice home exercises that reinforce treatment strategies. There are no costs to participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- NIH Stage 2 behavioral clinical trial
| Arm | Type | Receives |
|---|---|---|
| Communication Bridge™ | Experimental | Behavioral: Communication Bridge™Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm. |
| Evidence-Based Impairment Focused | Active comparator | Behavioral: Evidence-Based Impairment FocusedThe Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records)
- English as primary language used in daily communication activities (by self-report)
- Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
- Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report)
- Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
Key exclusion criteria (4 listed)
- A dementia diagnosis other than Primary Progressive Aphasia
- Participation is co-enrolled in an outside speech language therapy program during the study course.
- Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia)
- Medical records will be requested and reviewed to determine eligibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication Bridge™Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study. | Behavioural | Communication Bridge™ |
| Evidence-Based Impairment FocusedEvidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study. | Behavioural | Evidence-Based Impairment Focused |
Primary outcome
Change in Communication Participation Person Centered Goals
Time frame: 5 assessment time points through study completion (up to 18 months)
Goal Attainment Scaling, a 7-point rating scale with -3 representing 'no longer participating' and +3 representing 'exceeded goal'. Higher scores indicate better progress in goal achievement.
Change in Communication Participation
Time frame: 5 assessment time points through study completion (up to 18 months)
The CPIB measure is a 10-item, disorder-generic, Likert scale that asks persons to rate how their condition interferes with participating in daily communication activities (e.g., talking to people you know/do not know, securing a turn in a fast-moving conversation). The psychometric properties of the measure have been published previously (Baylor et al., 2013; Baylor et al., 2019). Both raw and T-scores are available. The CPIB T-score has a theoretical mean of 50 and standard deviation of 10 with higher numbers reflecting higher levels of participation in communication activities.
Montgomery Burden Inventory (MBI)
Time frame: 5 assessment time points through study completion (up to 18 months)
The MBI is a pen/paper Likert scale with 16 items distributed across three subscales (Montgomery et al., 1985) completed by the care partner. Total and mean item scores are calculated for each of the three subscales: Objective burden is defined as the perceived infringement of disruption of tangible aspects of a caregiver's life; Subjective demand/relational burden is typically described as the extent to which the caregiver perceives that the care recipient is overly demanding in the context of caregiving; Subjective stress burden is the emotional impact of caregiving responsibilities. Participants rate each item with a score between 1 (Not at all) and 5 (A great deal) corresponding to the amount of perceived burden. Higher scores reflect increased burden. Internal consistency .81 to .90. Construct validity demonstrated in mixed cohort of care partners of persons with dementia. Test-retest stability coefficients are robust (ICC of 0.92 to 0.91) (Farley et al., 2010).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Roglaski, PhD principal investigator
Professor of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Communication Bridge™ and Evidence-Based Impairment Focused in people with Primary Progressive Aphasia, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Bona, MPH (773-702-1220 ext. 51145, cbtrial@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Communication Participation Person Centered Goals (time frame: 5 assessment time points through study completion (up to 18 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.