Primary Progressive AphasiaNCT04881617
Treatment for Speech and Language in Primary Progressive Aphasia
A study testing Lexical Retrieval Training (LRT) and Video-Implemented Script Training for Aphasia (VISTA) in people with Primary Progressive Aphasia and Semantic Dementia, run by University of Texas at Austin at 2 sites in United States.
Trial summary
Primary progressive aphasia (PPA) is a progressive neurological disorder that causes a gradual decline in communication ability as a result of selective neurodegeneration of speech and language networks in the brain. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary Progressive Aphasia, Semantic Dementia, Semantic Memory Disorder
- What is being tested?
- Lexical Retrieval Training (LRT) and Video-Implemented Script Training for Aphasia (VISTA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2017to 30 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
- Score of 15 or higher on the Mini-Mental State Examination
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 15 on the Mini-Mental State Examination
- Prominent initial non-speech-language impairment (cognitive, behavioral, motoric)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas
Austin, Texas, 78712
University of California San Francisco
San Francisco, California, 94158
About this study
Official title: Establishing Evidence-based Treatment for Speech and Language in Primary Progressive Aphasia
Primary progressive aphasia (PPA) is a progressive neurological disorder that causes a gradual decline in communication ability as a result of selective neurodegeneration of speech and language networks in the brain. PPA is a devastating condition affecting adults as young as their 40's or 50's, depriving them of the ability to communicate and function in society. There has been significant progress in discovering the neurobiological mechanisms that underlie PPA and in identifying its clinical phenotypes. With these advances, we are poised to investigate behavioral treatments that are grounded in modern cognitive and neuroanatomical concepts. Research documenting the efficacy of speech-language treatment for PPA is emerging, but limited. Systematic research is needed to establish best clinical practices in this unique patient population for whom pharmacological treatment remains elusive. The long-term objectives of this project are to provide evidence-based treatment methods addressing the speech and language deficits in PPA and to determine the neural predictors of responsiveness to intervention. The study has three main goals that build on the findings of our previous work: 1) to examine the utility of treatments designed to facilitate significant, generalized and lasting improvement of speech-language function in PPA, 2) to determine whether treatment alters the trajectory of decline in PPA by comparing performance on primary outcome measures in treated versus untreated participants after a one-year interval, and 3) to identify imaging predictors (gray matter, white matter, and functional connectivity measures) of responsiveness to behavioral intervention in individuals with PPA. In order to accomplish these aims, we will enroll 60 individuals with PPA, who will undergo a comprehensive multidisciplinary evaluation and neuroimaging. Subsequently, participants will be enrolled in treatment designed to promote lasting and generalized improvement of communicative function in core speech-language domains. Participants will be followed for up to one-year post-treatment in order to determine long-term effects of rehabilitation, and their performance will be compared with a historical cohort of untreated PPA patients. This ambitious study and the necessary recruitment will be possible due to an ongoing collaboration with the UCSF Memory and Aging Center, a leading institution in the field of PPA research. The study will broaden the evidence base supporting the efficacy of speech-language intervention in PPA and will provide novel evidence regarding neural predictors of treatment outcomes, with the potential to inform clinical decision-making and improve clinical care for individuals with this debilitating disorder.
- Conditions
- Primary Progressive Aphasia, Semantic Dementia, Semantic Memory Disorder, Logopenic Progressive Aphasia, Nonfluent Aphasia, Progressive, Aphasia
- Being tested
- Lexical Retrieval Training (LRT), Video-Implemented Script Training for Aphasia (VISTA)
- Medical subject headings
- Aphasia, Primary Progressive, Frontotemporal Dementia, Memory Disorders, Primary Progressive Nonfluent Aphasia, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lexical Retrieval Training (LRT)Behavioural
In person or via teletherapy: Participants work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) sessions per week with a clinician plus daily home practice exercises.
Video-Implemented Script Training for Aphasia (VISTA)Behavioural
In person or via teletherapy: Participants work on producing personally relevant scripts of 4-6 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 target clear and accurate script production, script memorization, and conversational usage of scripts.
| Study group | Role | What they receive |
|---|---|---|
| Lexical Retrieval Treatment | Experimental | Not described Receives: Behavioral: Lexical Retrieval Training (LRT) |
| Script Training | Experimental | Not described Receives: Behavioral: Video-Implemented Script Training for Aphasia (VISTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spoken naming of target items
Change in percent correctly named trained/untrained pictures
Measured: change from pre-treatment to post-treatment (approximately 8-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment
Change in script production accuracy
Change in percent correct intelligible, scripted words for trained/untrained scripts
Measured: change from pre-treatment to post-treatment (approximately 6 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment
Secondary outcomes (3)
Change on Western Aphasia Battery, Revised
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, 6 months post-treatment, and 12 months post-treatment
Change on Boston Naming Test
change on standardized word retrieval assessment
Measured: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment
Change on Northwestern Assessment of Verbs and Sentences
change on standardized assessment of verb and sentence processing in aphasia
Measured: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 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 posted11 May 2021
- Study start1 Jul 2017
- Primary completion30 Aug 2025
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Texas at AustinThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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), University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Maya L Henry, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881617
- Sponsor's protocol ID
- R01DC016291
- Other IDs
- R01DC016291
- Status last verified
- Nov 2025
- First submitted
- 30 Apr 2021
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101.
PubMed 29718131Henry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7.
PubMed 31390290Dial HR, Hinshelwood HA, Grasso SM, Hubbard HI, Gorno-Tempini ML, Henry ML. Investigating the utility of teletherapy in individuals with primary progressive aphasia. Clin Interv Aging. 2019 Feb 25;14:453-471. doi: 10.2147/CIA.S178878. eCollection 2019.
PubMed 30880927
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Evidence-based Treatment for Speech and Language in Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT04881617
- Acronym / sponsor ID
- R01DC016291
- Conditions
- Primary Progressive Aphasia, Semantic Dementia, Semantic Memory Disorder, Logopenic Progressive Aphasia, Nonfluent Aphasia, Progressive, Aphasia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of California, San Francisco
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 May 2021 (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.
Primary progressive aphasia (PPA) is a progressive neurological disorder that causes a gradual decline in communication ability as a result of selective neurodegeneration of speech and language networks in the brain. PPA is a devastating condition affecting adults as young as their 40's or 50's, depriving them of the ability to communicate and function in society. There has been significant progress in discovering the neurobiological mechanisms that underlie PPA and in identifying its clinical phenotypes. With these advances, we are poised to investigate behavioral treatments that are grounded in modern cognitive and neuroanatomical concepts. Research documenting the efficacy of speech-language treatment for PPA is emerging, but limited. Systematic research is needed to establish best clinical practices in this unique patient population for whom pharmacological treatment remains elusive. The long-term objectives of this project are to provide evidence-based treatment methods addressing the speech and language deficits in PPA and to determine the neural predictors of responsiveness to intervention. The study has three main goals that build on the findings of our previous work: 1) to examine the utility of treatments designed to facilitate significant, generalized and lasting improvement of speech-language function in PPA, 2) to determine whether treatment alters the trajectory of decline in PPA by comparing performance on primary outcome measures in treated versus untreated participants after a one-year interval, and 3) to identify imaging predictors (gray matter, white matter, and functional connectivity measures) of responsiveness to behavioral intervention in individuals with PPA. In order to accomplish these aims, we will enroll 60 individuals with PPA, who will undergo a comprehensive multidisciplinary evaluation and neuroimaging. Subsequently, participants will be enrolled in treatment designed to promote lasting and generalized improvement of communicative function in core speech-language domains. Participants will be followed for up to one-year post-treatment in order to determine long-term effects of rehabilitation, and their performance will be compared with a historical cohort of untreated PPA patients. This ambitious study and the necessary recruitment will be possible due to an ongoing collaboration with the UCSF Memory and Aging Center, a leading institution in the field of PPA research. The study will broaden the evidence base supporting the efficacy of speech-language intervention in PPA and will provide novel evidence regarding neural predictors of treatment outcomes, with the potential to inform clinical decision-making and improve clinical care for individuals with this debilitating disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lexical Retrieval Treatment | Experimental | Behavioral: Lexical Retrieval Training (LRT) |
| Script Training | Experimental | Behavioral: Video-Implemented Script Training for Aphasia (VISTA) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
- Score of 15 or higher on the Mini-Mental State Examination
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 15 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 |
|---|---|---|
| Lexical Retrieval Training (LRT)In person or via teletherapy: Participants work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) sessions per week with a clinician plus daily home practice exercises. | Behavioural | Lexical Retrieval Treatment |
| Video-Implemented Script Training for Aphasia (VISTA)In person or via teletherapy: Participants work on producing personally relevant scripts of 4-6 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 target clear and accurate script production, script memorization, and conversational usage of scripts. | Behavioural | Script Training |
Primary outcome
Change in spoken naming of target items
Time frame: change from pre-treatment to post-treatment (approximately 8-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment
Change in percent correctly named trained/untrained pictures
Change in script production accuracy
Time frame: change from pre-treatment to post-treatment (approximately 6 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment
Change in percent correct intelligible, scripted words for trained/untrained scripts
3 secondary outcomes
Change on Western Aphasia Battery, Revised
Time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment
Change on Boston Naming Test
Time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment
Change on Northwestern Assessment of Verbs and Sentences
Time frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 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 13 Nov 2025.
- Background: PubMed 29718131Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101.
- Background: PubMed 31390290Henry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7.
- Background: PubMed 30880927Dial HR, Hinshelwood HA, Grasso SM, Hubbard HI, Gorno-Tempini ML, Henry ML. Investigating the utility of teletherapy in individuals with primary progressive aphasia. Clin Interv Aging. 2019 Feb 25;14:453-471. doi: 10.2147/CIA.S178878. eCollection 2019.
- University of Texas Aphasia Research and Treatment LabLink provided by the sponsor.
- UCSF Language Neurobiology LabLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Maya L Henry, PhD principal investigator
University of Texas at Austin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lexical Retrieval Training (LRT) and Video-Implemented Script Training for Aphasia (VISTA) in people with Primary Progressive Aphasia and Semantic Dementia, run by University of Texas at Austin at 2 sites 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 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 spoken naming of target items (time frame: change from pre-treatment to post-treatment (approximately 8-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment). The study lists 2 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 NCT04881617, which also lists 3 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 13 Nov 2025.