Primary Progressive AphasiaCB2NCT03371706

Communication Bridge 2

A 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild 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 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: 190 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2018to 23 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

United States1 site

The Healthy Aging & Alzheimer's Research Care Center (University of Chicago)
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia

Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for 12 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive 5 evaluations and 15 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, primary progressive aphasia, dementia, communication, frontotemporal dementia, Alzheimer's 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 groups in NCT03371706
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 Confidence (CCRSA)
Communication Confidence Rating Scale in Aphasia, a 0-100 numeric rating scale with 0 representing 'not confident' and 100 representing 'very confident'. Higher scores indicate greater confidence.
Measured: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
Change in Communication Participation Item Bank (CPIB)
Communication Participation Item Bank is a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges.
We are reporting on change in CPIB scores using T-scores. The Communicative Participation Item Bank (CPIB) T-score range is as follows:
T57.5 and above: Represents a "normal" experience of communicative participation or "minimal problems" T57.5-T45: Represents mild challenges T45-T35: Represents moderate challenges T35 and below: Represents severe challenges
The CPIB is a patient-reported instrument that measures communicative participation. The mean T-score is 50, and the standard deviation is 10. Higher scores are more favorable, indicating less interference in participation. The ideal score, or someone who reports no problems with communicative participation, would be a T-score of 74.3
Measured: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
Change in Communication Participation Person Centered Goals
This measure assesses progress toward communication participation goals using Goal Attainment Scaling (GAS). Participants developed personalized goals, each set to a baseline value of '0'. Progress was tracked using a 7-point scale, where -3 represents 'no longer participating' and +3 represents 'exceeded goal'. Higher scores indicate better progress toward goal achievement. Goals were evaluated at 3, 6, 9, and 12 months, with the results reported as the percentage of goals that:
Worsened (scores of -1, -2, or -3) No change (score remained at 0) Improved (scores of +1, +2, or +3), including getting close to, reaching, or exceeding the goal.
The table below presents the percentage of goals falling into each of these categories at each assessment point.
Measured: 4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 201823 Mar 2023

First posted13 Dec 2017
Study start3 Apr 2018
Primary completion23 Mar 2023
Study completion23 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: NIH Stage 2 behavioral clinical trial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03371706
Sponsor's protocol ID: IRB23-1334
Other IDs: 1R01AG055425-01A1
Acronym: CB2
Status last verified: Aug 2024
First submitted: 8 Dec 2017
Last updated: 17 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Roberts AC, Rademaker AW, Salley EA, Mooney A, Morhardt D, Fried-Oken M, Weintraub S, Mesulam M, Rogalski E. Communication Bridge-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia. Trials. 2022 Jun 13;23(1):487. doi: 10.1186/s13063-022-06162-7.
PubMed 35698099
Mesulam MM, Coventry C, Kuang A, Bigio EH, Mao Q, Flanagan ME, Gefen T, Sridhar J, Geula C, Zhang H, Weintraub S, Rogalski EJ. Memory Resilience in Alzheimer Disease With Primary Progressive Aphasia. Neurology. 2021 Feb 9;96(6):e916-e925. doi: 10.1212/WNL.0000000000011397. Epub 2021 Jan 13.
PubMed 33441454

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease, GM1 Gangliosidosis or GM2 Gangliosidosis
Niemann-Pick Type C Disease, GM1 Gangliosidosis
Not yet recruiting
Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
Enrolling by invitationPhase 2
Alzheimer's Tau Platform: Regimen A - AADvac1
Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Evaluation of Biochemical Markers and Clinical Investigation of Niemann-Pick Disease, Type C
Niemann-Pick Disease, Type C

All Primary Progressive Aphasia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia
ClinicalTrials.gov ID: NCT03371706
Acronym / sponsor ID: CB2 / IRB23-1334
Conditions: Primary Progressive Aphasia
Keywords: aphasia, primary progressive aphasia, dementia, communication, frontotemporal dementia, Alzheimer's disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 3 Apr 2018 (actual)
Primary completion: 23 Mar 2023 (actual)
Study completion: 23 Mar 2023 (actual)
First posted: 13 Dec 2017 (actual)
Results: Posted 17 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
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 Confidence (CCRSA)
Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
Communication Confidence Rating Scale in Aphasia, a 0-100 numeric rating scale with 0 representing 'not confident' and 100 representing 'very confident'. Higher scores indicate greater confidence.
Change in Communication Participation Item Bank (CPIB)
Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
Communication Participation Item Bank is a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges. We are reporting on change in CPIB scores using T-scores. The Communicative Participation Item Bank (CPIB) T-score range is as follows: T57.5 and above: Represents a "normal" experience of communicative participation or "minimal problems" T57.5-T45: Represents mild challenges T45-T35: Represents moderate challenges T35 and below: Represents severe challenges The CPIB is a patient-reported instrument that measures communicative participation. The mean T-score is 50, and the standard deviation is 10. Higher scores are more favorable, indicating less interference in participation. The ideal score, or someone who reports no problems with communicative participation, would be a T-score of 74.3
Change in Communication Participation Person Centered Goals
Time frame: 4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
This measure assesses progress toward communication participation goals using Goal Attainment Scaling (GAS). Participants developed personalized goals, each set to a baseline value of '0'. Progress was tracked using a 7-point scale, where -3 represents 'no longer participating' and +3 represents 'exceeded goal'. Higher scores indicate better progress toward goal achievement. Goals were evaluated at 3, 6, 9, and 12 months, with the results reported as the percentage of goals that: Worsened (scores of -1, -2, or -3) No change (score remained at 0) Improved (scores of +1, +2, or +3), including getting close to, reaching, or exceeding the goal. The table below presents the percentage of goals falling into each of these categories at each assessment point.

Results and safety

Results posted to the registry on 17 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Communication Bridge™ (Persons With Primary Progressive Aphasia)	56	50
Communication Bridge™ (Care Partners	56	50
Evidence-Based Impairment Focused (Persons With Primary Progressive Aphasia)	39	39
Evidence-Based Impairment Focused (Care Partners)	39	39

Primary outcome: Change in Communication Confidence (CCRSA)

Time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months. Mean (Standard Error). Unit: units on a scale

Measure	Communication Bridge™ (Person With Primary Progressive Aphasia) n = 56	Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) n = 39
Baseline	72.6 (1.8)	72.9 (2.6)
Post Intervention 1 (3 months)	73.7 (1.9)	74.5 (2.4)
Six Months	72.1 (2.1)	73.1 (2.5)
Post Intervention 2 (9 months)	72.2 (2.2)	71.6 (2.5)
12 Months	69.1 (2.7)	70.1 (2.5)

Population analysed: the number analyzed in some rows differs from the overall number analyzed due to participant withdrawal and missing data.

Primary outcome: Change in Communication Participation Item Bank (CPIB)

Measure	Communication Bridge™ (Person With Primary Progressive Aphasia) n = 56	Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) n = 39
Baseline	46.0 (0.8)	47.1 (1.0)
Post Intervention 1 (3 months)	47.4 (0.9)	47.7 (1.9)
Six Months	45.6 (1.0)	46.8 (1.1)
Post Intervention 2 (9 months)	46.0 (0.9)	46.3 (1.0)
12 Months	45.5 (1.0)	45.0 (1.0)

Population analysed: the number analyzed in some rows differs from the overall number analyzed due to participant withdrawal and missing data.

Primary outcome: Change in Communication Participation Person Centered Goals

Time frame: 4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months. Number. Unit: percentage of goals

Measure	Communication Bridge™ (Person With Primary Progressive Aphasia) n = 53	Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia) n = 39
Post Intervention 1 - (Worse than baseline)	3.8	6.9
Post Intervention 1 - (No change from baseline)	29.6	44.0
Post Intervention 1 - (Getting close to, reached, or exceed) goal	66.7	49.1
Six Months - (Worse than baseline)	16.3	18.0
Six Months - (No change from baseline)	23.5	35.0
Six Months - (Getting close to , reached, or exceeded expected goal)	60.1	47.0
Post Intervention 2 - (Worse than baseline)	16.0	18.8
Post Intervention 2 - (No change from baseline)	22.0	26.5

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Communication Bridge™	7 of 56 (12.5%)	5 of 56 (8.9%)	0 of 56
Evidence-Based Impairment Focused	4 of 39 (10.3%)	7 of 39 (17.9%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35698099Roberts AC, Rademaker AW, Salley EA, Mooney A, Morhardt D, Fried-Oken M, Weintraub S, Mesulam M, Rogalski E. Communication Bridge-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia. Trials. 2022 Jun 13;23(1):487. doi: 10.1186/s13063-022-06162-7.
Derived from this study: PubMed 33441454Mesulam MM, Coventry C, Kuang A, Bigio EH, Mao Q, Flanagan ME, Gefen T, Sridhar J, Geula C, Zhang H, Weintraub S, Rogalski EJ. Memory Resilience in Alzheimer Disease With Primary Progressive Aphasia. Neurology. 2021 Feb 9;96(6):e916-e925. doi: 10.1212/WNL.0000000000011397. Epub 2021 Jan 13.
Individual participant dataSharing planned: Yes

Related trials for Primary Progressive Aphasia

RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease, GM1 Gangliosidosis or GM2 Gangliosidosis
Niemann-Pick Type C Disease, GM1 Gangliosidosis
Not yet recruiting
Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
Enrolling by invitationPhase 2
Alzheimer's Tau Platform: Regimen A - AADvac1
Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Evaluation of Biochemical Markers and Clinical Investigation of Niemann-Pick Disease, Type C
Niemann-Pick Disease, Type C

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. This study is not recruiting at the moment.

Emily Rogalski, Ph.D. principal investigator

University of Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A 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: finished, as of the sponsor's last update on 17 Oct 2024. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Communication Confidence (CCRSA) (time frame: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 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?

On the ClinicalTrials.gov record for NCT03371706, which also lists 2 linked publications.

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 17 Oct 2024.