Primary Progressive AphasiaNCT06649084
Primary Progressive Aphasia Multicomponent Language Treatment Study
A study testing Multicomponent Lexical Retrieval Training (Multi-LRT), Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA) and Multicomponent Communication Partner Training (Multi-CPT) in people with Primary Progressive Aphasia and Semantic Dementia, run by University of Texas at Austin at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a speech-language telerehabilitation helps improve communication in people with primary progressive aphasia (PPA), a form of dementia that affects speech and language. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Progressive Aphasia, Semantic Dementia, Semantic Memory Disorder
- What is being tested?
- Multicomponent Lexical Retrieval Training (Multi-LRT), Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA) and Multicomponent Communication Partner Training (Multi-CPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 31 Dec 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
- Scores of 10 or higher on the Mini-Mental State Examination
- Has a study partner who can consistently attend sessions
Who cannot join
- Other neurological or psychiatric diagnosis that may contribute to cognitive-linguistic deficits
- Significant, uncorrected visual or hearing impairment that would interfere with participation
- Score of less than 10 on the Mini-Mental State Examination
- Prominent initial non-speech-language impairment (cognitive, behavioral, motoric)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Establishing Evidence-based Multicomponent Treatment for Speech and Language in Primary Progressive Aphasia
The goal of this clinical trial is to learn if a speech-language telerehabilitation helps improve communication in people with primary progressive aphasia (PPA), a form of dementia that affects speech and language. The study will also document how acceptable and helpful the program is for both patients and their care partners.
The main questions the study aims to answer are:
Read more
- Is the telerehabilitation program feasible and acceptable for people with PPA and their care partners?
- Do participants with PPA and care partners report satisfaction with the program?
- Which outcome measures are most useful for evaluating changes in communication and quality of life?
- What patterns of treatment response are seen in participants after completing the program?
Researchers will test the program in a small group of participants to see how people respond. The program includes both speech-language therapy and training for care partners.
Participants will:
- Take part in online speech-language therapy sessions
- Complete communication tasks and questionnaires before and after the program
- Have regular virtual check-ins with the research team
- Include their care partners in some parts of the program for training and support
- Conditions
- Primary Progressive Aphasia, Semantic Dementia, Semantic Memory Disorder, Logopenic Progressive Aphasia, Nonfluent Aphasia, Progressive, Aphasia
- Being tested
- Multicomponent Lexical Retrieval Training (Multi-LRT), Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA), Multicomponent Communication Partner Training (Multi-CPT)
- Keywords
- Speech-Language Pathology, Neurodegenerative Disease, Logopenic, Semantic, Nonfluent, Speech Entrainment, Telethearpy, Multimodal Communication Training, Partner Training, Augmentative and Alternative Communication, Script training
- Medical subject headings
- Aphasia, Primary Progressive, Frontotemporal Dementia, Memory Disorders, Primary Progressive Nonfluent Aphasia, Aphasia, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Lexical Retrieval Training (Multi-LRT)Behavioural
In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Participants work on producing names of personally relevant target in multiple communication modalities. Treatment focuses on the use of strategies which capitalize on residual linguistic ability and autobiographical memory to support word retrieval. The participant completes two one-hour-long sessions per week plus daily homework. The participant also meets 4 times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies.
Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA)Behavioural
In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Participants work on producing personally relevant scripts of 3-5 sentences in length. Length and complexity of scripts are individually tailored. The participant completes 30 minutes per day of home practice, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts. Biweekly (one hour each) sessions with a clinician are held which target clear and accurate script production, script memorization, and conversational usage of the script and multimodal communication. The participant also meets 6 times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies.
Multicomponent Communication Partner Training (Multi-CPT)Behavioural
In person or via teletherapy: A multi-component treatment incorporating elements of compensatory and care-partner focused interventions. Biweekly (one hour each) sessions with a clinician are held which target use of communication strategies including multimodal communication for the participant and study partner (e.g., spouse). The participant also completes regular assignments meant to increase generalization of communication strategies and progress on personal goals.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Lexical Retrieval Training (Multi-LRT) | Experimental | Not described Receives: Behavioral: Multicomponent Lexical Retrieval Training (Multi-LRT) |
| Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA) | Experimental | Not described Receives: Behavioral: Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA) |
| Experimental: Multicomponent Communicaiton Partner Training (Multi-CPT) | Experimental | Not described Receives: Behavioral: Multicomponent Communication Partner Training (Multi-CPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in script production accuracy
Percent correct intelligible, scripted words for trained/untrained scripts
Measured: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Change in spoken naming of trained/untrained items
Percent correctly named trained/untrained pictures
Measured: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Information communicated in any modality for trained/untrained stimuli
Percent of major content units (key words) communicated via speech or nonspeech modalities (e.g., writing, drawing, gesture) for trained/untrained scripts (Multi-VISTA) or words (Multi-LRT) during structured probes and in conversation
Measured: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Goal Attainment Score
The Goal Attainment Score is self-reported progress on personalized goals based on a five point scale.
Measured: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Secondary outcomes (2)
Change on Quick Aphasia Battery
change on standardized aphasia assessment
Measured: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Change on Aphasia Impact Questionnaire
change on psychosocial questionnaire for individuals with aphasia
Measured: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start2 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Maya Henry, University of Texas at Austin
- Investigators
- Maya L Henry, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649084
- Sponsor's protocol ID
- R56DC016291
- Other IDs
- R56DC016291
- Status last verified
- Sep 2025
- First submitted
- 16 Oct 2024
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Evidence-based Multicomponent Treatment for Speech and Language in Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT06649084
- Acronym / sponsor ID
- R56DC016291
- Conditions
- Primary Progressive Aphasia, Semantic Dementia, Semantic Memory Disorder, Logopenic Progressive Aphasia, Nonfluent Aphasia, Progressive, Aphasia
- Keywords
- Speech-Language Pathology, Neurodegenerative Disease, Logopenic, Semantic, Nonfluent, Speech Entrainment, Telethearpy, Multimodal Communication Training
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Oct 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.
The goal of this clinical trial is to learn if a speech-language telerehabilitation helps improve communication in people with primary progressive aphasia (PPA), a form of dementia that affects speech and language. The study will also document how acceptable and helpful the program is for both patients and their care partners.
The main questions the study aims to answer are:
- Is the telerehabilitation program feasible and acceptable for people with PPA and their care partners?
- Do participants with PPA and care partners report satisfaction with the program?
- Which outcome measures are most useful for evaluating changes in communication and quality of life?
- What patterns of treatment response are seen in participants after completing the program?
Researchers will test the program in a small group of participants to see how people respond. The program includes both speech-language therapy and training for care partners.
Participants will:
- Take part in online speech-language therapy sessions
- Complete communication tasks and questionnaires before and after the program
- Have regular virtual check-ins with the research team
- Include their care partners in some parts of the program for training and support
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Lexical Retrieval Training (Multi-LRT) | Experimental | Behavioral: Multicomponent Lexical Retrieval Training (Multi-LRT) |
| Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA) | Experimental | Behavioral: Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA) |
| Experimental: Multicomponent Communicaiton Partner Training (Multi-CPT) | Experimental | Behavioral: Multicomponent Communication Partner Training (Multi-CPT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
- Scores of 10 or higher on the Mini-Mental State Examination
- Has a study partner who can consistently attend sessions
Key exclusion criteria (4 listed)
- Other neurological or psychiatric diagnosis that may contribute to cognitive-linguistic deficits
- Significant, uncorrected visual or hearing impairment that would interfere with participation
- Score of less than 10 on the Mini-Mental State Examination
- Prominent initial non-speech-language impairment (cognitive, behavioral, motoric)
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 |
|---|---|---|
| Multicomponent Lexical Retrieval Training (Multi-LRT)In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Participants work on producing names of personally relevant target in multiple communication modalities. Treatment focuses on the use of strategies which capitalize on residual linguistic ability and autobiographical memory to support word retrieval. The participant completes two one-hour-long sessions per week plus daily homework. The participant also meets 4 times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies. | Behavioural | Multicomponent Lexical Retrieval Training (Multi-LRT) |
| Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA)In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Participants work on producing personally relevant scripts of 3-5 sentences in length. Length and complexity of scripts are individually tailored. The participant completes 30 minutes per day of home practice, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts. Biweekly (one hour each) sessions with a clinician are held which target clear and accurate script production, script memorization, and conversational usage of the script and multimodal communication. The participant also meets 6 times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies. | Behavioural | Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA) |
| Multicomponent Communication Partner Training (Multi-CPT)In person or via teletherapy: A multi-component treatment incorporating elements of compensatory and care-partner focused interventions. Biweekly (one hour each) sessions with a clinician are held which target use of communication strategies including multimodal communication for the participant and study partner (e.g., spouse). The participant also completes regular assignments meant to increase generalization of communication strategies and progress on personal goals. | Behavioural | Experimental: Multicomponent Communicaiton Partner Training (Multi-CPT) |
Primary outcome
Change in script production accuracy
Time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Percent correct intelligible, scripted words for trained/untrained scripts
Change in spoken naming of trained/untrained items
Time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Percent correctly named trained/untrained pictures
Information communicated in any modality for trained/untrained stimuli
Time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Percent of major content units (key words) communicated via speech or nonspeech modalities (e.g., writing, drawing, gesture) for trained/untrained scripts (Multi-VISTA) or words (Multi-LRT) during structured probes and in conversation
Goal Attainment Score
Time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
The Goal Attainment Score is self-reported progress on personalized goals based on a five point scale.
2 secondary outcomes
Change on Quick Aphasia Battery
Time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
Change on Aphasia Impact Questionnaire
Time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
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 8 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Maya L Henry, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Lexical Retrieval Training (Multi-LRT), Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA) and Multicomponent Communication Partner Training (Multi-CPT) in people with Primary Progressive Aphasia and Semantic Dementia, run by University of Texas at Austin 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 3 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: enrolling by invitation, as of the sponsor's last update on 8 Oct 2025. 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?
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?
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 script production accuracy (time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment). The study lists 4 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 8 Oct 2025.