Primary Progressive AphasiaNCT05741853
Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia
A study testing Video-Implemented Script Training for Aphasia (VISTA) and Lexical Retrieval Training (LRT) in people with Primary Progressive Aphasia and Dementia, run by Stephanie Grasso at 3 sites in 2 countries.
Trial summary
Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Progressive Aphasia, Dementia, Dementia, Frontotemporal
- What is being tested?
- Video-Implemented Script Training for Aphasia (VISTA) and Lexical Retrieval Training (LRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 May 2023to 30 Nov 2027
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
- Bilingual in Spanish and Catalan or bilingual in Spanish and English
- Different proficiency levels across languages are expected, any prior experience in both languages is acceptable
- Intervention study: Score of 15 or higher on the Mini-Mental State Examination
- Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of 10 or higher on the Mini-Mental State Examination
Who cannot join
- Other central nervous system or medical diagnosis that can cause symptoms
- Other psychiatric diagnosis that can cause symptoms
- Significant, uncorrected visual or hearing impairment that would interfere with participation
- Prominent initial non-speech-language impairments (cognitive, behavioral, motoric)
- Intervention Study: Score of less than 15 on the Mini-Mental State Examination
- Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of less than 10 on the Mini-Mental State Examination
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Spain2 sites, 2 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Estefania Garcia, egarciah@santpau.cat
Miguel A Santos Santos, MD
- Not yet recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Núria Montagut Colomer, NMONTAGU@clinic.cat
United States1 site, 1 recruiting
- Recruiting
University of Texas at Austin
Austin, Texas, 78752
Camille Wagner Rodríguez, M.S., wagner.camille@austin.utexas.edu
Stephanie M Grasso, Ph.D.
About this study
Official title: Cognitive Reserve and Linguistic Resilience in Bilingual Hispanics With Primary Progressive Aphasia
Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA.
The overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how "strong" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.
- Conditions
- Primary Progressive Aphasia, Dementia, Dementia, Frontotemporal, Alzheimer Disease, Neurodegenerative Diseases, Frontotemporal Lobar Degeneration
- Being tested
- Video-Implemented Script Training for Aphasia (VISTA), Lexical Retrieval Training (LRT)
- Keywords
- Dementia, ADRD, Bilingualism, Multilingualism, Primary Progressive Aphasia, Bilingual Primary Progressive Aphasia, Cognitive Reserve, Language Decline, Bilingual Language Decline, Speech-Language Therapy, Bilingual Speech-Language Therapy, Spanish speakers, Spanish-Catalan Bilinguals, Spanish-English Bilinguals, Hispanic, Catalán, Catalan, Spanish, Castellano, Speech Therapy, Latino
- Medical subject headings
- Aphasia, Primary Progressive, Dementia, Frontotemporal Dementia, Alzheimer Disease, Neurodegenerative Diseases, Frontotemporal Lobar Degeneration, Apraxias, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Implemented Script Training for Aphasia (VISTA)Behavioural
Also called Script training
Participants with nonfluent/agrammatic variant primary progressive aphasia (PPA) or a predominantly nonfluent profile work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes two (one hour each) teletherapy sessions per week with a clinician targeting clear and accurate script production, script memorization, and conversational usage of scripts. The participant completes 30 minutes of independent, computer-based practice 5-7 times per week, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts.
Lexical Retrieval Training (LRT)Behavioural
Also called Naming intervention
Participants with logopenic variant PPA, participants with semantic variant PPA, and participants with a predominantly anomic profile will 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) teletherapy sessions per week with a clinician plus 30 minutes of additional independent, computer-based practice exercises 5-7 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Lexical Retrieval Training | Experimental | Naming intervention for individuals with logopenic or semantic variant PPA. Receives: Behavioral: Video-Implemented Script Training for Aphasia (VISTA); Behavioral: Lexical Retrieval Training (LRT) |
| Video Implemented Script Training for Aphasia | Experimental | Script training intervention for individuals with nonfluent/agrammatic PPA. Receives: Behavioral: Video-Implemented Script Training for Aphasia (VISTA); Behavioral: Lexical Retrieval Training (LRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent correct intelligible words from trained/untrained scripts
Percent of intelligible, scripted words for trained scripts and untrained scripts
Measured: Pre-phase 1, post-phase1/pre-phase 2 (4.5 weeks from treatment onset), post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Percent correct spoken naming of trained/untrained nouns
Percent of correctly named trained pictured items and untrained pictured items
Measured: Pre-phase 1, post-phase1/pre-phase 2 (4.5 weeks from treatment onset), post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Secondary outcomes (5)
Aphasia Impact Questionnaire (AIQ)
Patient reported outcome measure for use with people with aphasia comprising three sections: activities, participation and emotional state/wellbeing. Uses a 5 point pictorial rating scale. The minimum score is 0 (best) and the maximum is 4 (worst).
Measured: Pre-phase 1, Post-phase 2 (9 weeks from treatment onset)
Connected Speech Features: Type-token ratio
Total number of unique words (types) divided by the total number of words (tokens) derived from connected speech samples (script topic probes, picture description, and personal narrative).
Measured: Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Connected Speech Features: Mean length of utterance
Average number of words produced per utterance derived from connected speech samples (script topic probes, picture description, and personal narrative).
Measured: Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Acoustic Features: Articulation Rate
Syllables per second of phonated time derived from connected speech samples (script topic probes, picture description, and personal narrative).
Measured: Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Acoustic Features: Speech-to-pause time
Phonated time divided by pause time in the sample derived from connected speech samples (script topic probes, picture description, and personal narrative).
Measured: Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 May 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephanie Grasso
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona
- Responsible party
- Sponsor-investigator, Stephanie Grasso, University of Texas at Austin
- Investigators
- Stephanie M Grasso, Ph.D, Principal investigator, University of Texas at AustinMiguel Ángel Santos Santos, MD, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741853
- Sponsor's protocol ID
- R01AG080470
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated from this project will be shared via peer reviewed journal publications as well as through national and international conferences. All peer-reviewed manuscripts will be made available via PubMed Central, in adherence to the NIH Public Access Policy. Intervention protocols, de-identified summary data, and software code/scripts used for data analysis will be made publicly available upon publication of trial results. De-identified data from individual participants may be made available to the scientific community with approved data use and sharing agreements between the University of Texas, Hospital Sant Pau, Hospital Clínic de Barcelona, and requesting institutions or entities, consistent with institution policy.
Publications
Klimova B, Maresova P, Valis M, Hort J, Kuca K. Alzheimer's disease and language impairments: social intervention and medical treatment. Clin Interv Aging. 2015 Aug 27;10:1401-7. doi: 10.2147/CIA.S89714. eCollection 2015.
PubMed 26346123Szatloczki G, Hoffmann I, Vincze V, Kalman J, Pakaski M. Speaking in Alzheimer's Disease, is That an Early Sign? Importance of Changes in Language Abilities in Alzheimer's Disease. Front Aging Neurosci. 2015 Oct 20;7:195. doi: 10.3389/fnagi.2015.00195. eCollection 2015.
PubMed 26539107Mesulam MM. Slowly progressive aphasia without generalized dementia. Ann Neurol. 1982 Jun;11(6):592-8. doi: 10.1002/ana.410110607.
PubMed 7114808Montembeault M, Brambati SM, Gorno-Tempini ML, Migliaccio R. Clinical, Anatomical, and Pathological Features in the Three Variants of Primary Progressive Aphasia: A Review. Front Neurol. 2018 Aug 21;9:692. doi: 10.3389/fneur.2018.00692. eCollection 2018.
PubMed 30186225Gorno-Tempini ML, Hillis AE, Weintraub S, Kertesz A, Mendez M, Cappa SF, Ogar JM, Rohrer JD, Black S, Boeve BF, Manes F, Dronkers NF, Vandenberghe R, Rascovsky K, Patterson K, Miller BL, Knopman DS, Hodges JR, Mesulam MM, Grossman M. Classification of primary progressive aphasia and its variants. Neurology. 2011 Mar 15;76(11):1006-14. doi: 10.1212/WNL.0b013e31821103e6. Epub 2011 Feb 16.
PubMed 21325651Carthery-Goulart MT, da Silveira ADC, Machado TH, Mansur LL, Parente MAMP, Senaha MLH, Brucki SMD, Nitrini R. Nonpharmacological interventions for cognitive impairments following primary progressive aphasia: a systematic review of the literature. Dement Neuropsychol. 2013 Jan-Mar;7(1):122-131. doi: 10.1590/S1980-57642013DN70100018.
PubMed 29213828Bialystok E, Craik FI, Freedman M. Bilingualism as a protection against the onset of symptoms of dementia. Neuropsychologia. 2007 Jan 28;45(2):459-64. doi: 10.1016/j.neuropsychologia.2006.10.009. Epub 2006 Nov 27.
PubMed 17125807Alladi S, Bak TH, Shailaja M, Gollahalli D, Rajan A, Surampudi B, Hornberger M, Duggirala V, Chaudhuri JR, Kaul S. Bilingualism delays the onset of behavioral but not aphasic forms of frontotemporal dementia. Neuropsychologia. 2017 May;99:207-212. doi: 10.1016/j.neuropsychologia.2017.03.021. Epub 2017 Mar 18.
PubMed 28322905Alladi S, Bak TH, Duggirala V, Surampudi B, Shailaja M, Shukla AK, Chaudhuri JR, Kaul S. Bilingualism delays age at onset of dementia, independent of education and immigration status. Neurology. 2013 Nov 26;81(22):1938-44. doi: 10.1212/01.wnl.0000436620.33155.a4. Epub 2013 Nov 6.
PubMed 24198291de Leon J, Grasso SM, Welch A, Miller Z, Shwe W, Rabinovici GD, Miller BL, Henry ML, Gorno-Tempini ML. Effects of bilingualism on age at onset in two clinical Alzheimer's disease variants. Alzheimers Dement. 2020 Dec;16(12):1704-1713. doi: 10.1002/alz.12170. Epub 2020 Sep 3.
PubMed 32881346Costa AS, Jokel R, Villarejo A, Llamas-Velasco S, Domoto-Reilley K, Wojtala J, Reetz K, Machado A. Bilingualism in Primary Progressive Aphasia: A Retrospective Study on Clinical and Language Characteristics. Alzheimer Dis Assoc Disord. 2019 Jan-Mar;33(1):47-53. doi: 10.1097/WAD.0000000000000288.
PubMed 30640254Grasso SM, Pena ED, Kazemi N, Mirzapour H, Neupane R, Bonakdarpour B, Gorno-Tempini ML, Henry ML. Treatment for Anomia in Bilingual Speakers with Progressive Aphasia. Brain Sci. 2021 Oct 20;11(11):1371. doi: 10.3390/brainsci11111371.
PubMed 34827370Grasso SM, Shuster KM, Henry ML. Comparing the effects of clinician and caregiver-administered lexical retrieval training for progressive anomia. Neuropsychol Rehabil. 2019 Jul;29(6):866-895. doi: 10.1080/09602011.2017.1339358. Epub 2017 Jun 30.
PubMed 28662598Henry 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 31390290
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Reserve and Linguistic Resilience in Bilingual Hispanics With Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT05741853
- Acronym / sponsor ID
- R01AG080470
- Conditions
- Primary Progressive Aphasia, Dementia, Dementia, Frontotemporal, Alzheimer Disease, Neurodegenerative Diseases, Frontotemporal Lobar Degeneration
- Keywords
- Dementia, ADRD, Bilingualism, Multilingualism, Primary Progressive Aphasia, Bilingual Primary Progressive Aphasia, Cognitive Reserve, Language Decline, Bilingual Language Decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stephanie GrassoUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 23 Feb 2023 (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.
Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA.
The overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how "strong" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.
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 Training | Experimental | Behavioral: Video-Implemented Script Training for Aphasia (VISTA), Behavioral: Lexical Retrieval Training (LRT)Naming intervention for individuals with logopenic or semantic variant PPA. |
| Video Implemented Script Training for Aphasia | Experimental | Behavioral: Video-Implemented Script Training for Aphasia (VISTA), Behavioral: Lexical Retrieval Training (LRT)Script training intervention for individuals with nonfluent/agrammatic PPA. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
- Bilingual in Spanish and Catalan or bilingual in Spanish and English
- Different proficiency levels across languages are expected, any prior experience in both languages is acceptable
- Intervention study: Score of 15 or higher on the Mini-Mental State Examination
- Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of 10 or higher on the Mini-Mental State Examination
Key exclusion criteria (6 listed)
- Other central nervous system or medical diagnosis that can cause symptoms
- Other psychiatric diagnosis that can cause symptoms
- Significant, uncorrected visual or hearing impairment that would interfere with participation
- Prominent initial non-speech-language impairments (cognitive, behavioral, motoric)
- Intervention Study: Score of less than 15 on the Mini-Mental State Examination
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 |
|---|---|---|
| Video-Implemented Script Training for Aphasia (VISTA)Also: Script trainingParticipants with nonfluent/agrammatic variant primary progressive aphasia (PPA) or a predominantly nonfluent profile work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes two (one hour each) teletherapy sessions per week with a clinician targeting clear and accurate script production, script memorization, and conversational usage of scripts. The participant completes 30 minutes of independent, computer-based practice 5-7 times per week, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts. | Behavioural | Lexical Retrieval Training, Video Implemented Script Training for Aphasia |
| Lexical Retrieval Training (LRT)Also: Naming interventionParticipants with logopenic variant PPA, participants with semantic variant PPA, and participants with a predominantly anomic profile will 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) teletherapy sessions per week with a clinician plus 30 minutes of additional independent, computer-based practice exercises 5-7 times per week. | Behavioural | Lexical Retrieval Training, Video Implemented Script Training for Aphasia |
Primary outcome
Percent correct intelligible words from trained/untrained scripts
Time frame: Pre-phase 1, post-phase1/pre-phase 2 (4.5 weeks from treatment onset), post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Percent of intelligible, scripted words for trained scripts and untrained scripts
Percent correct spoken naming of trained/untrained nouns
Time frame: Pre-phase 1, post-phase1/pre-phase 2 (4.5 weeks from treatment onset), post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Percent of correctly named trained pictured items and untrained pictured items
5 secondary outcomes
Aphasia Impact Questionnaire (AIQ)
Time frame: Pre-phase 1, Post-phase 2 (9 weeks from treatment onset)
Connected Speech Features: Type-token ratio
Time frame: Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Connected Speech Features: Mean length of utterance
Time frame: Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Acoustic Features: Articulation Rate
Time frame: Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
Acoustic Features: Speech-to-pause time
Time frame: Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year 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 10 Jun 2026.
- Background: PubMed 26346123Klimova B, Maresova P, Valis M, Hort J, Kuca K. Alzheimer's disease and language impairments: social intervention and medical treatment. Clin Interv Aging. 2015 Aug 27;10:1401-7. doi: 10.2147/CIA.S89714. eCollection 2015.
- Background: PubMed 26539107Szatloczki G, Hoffmann I, Vincze V, Kalman J, Pakaski M. Speaking in Alzheimer's Disease, is That an Early Sign? Importance of Changes in Language Abilities in Alzheimer's Disease. Front Aging Neurosci. 2015 Oct 20;7:195. doi: 10.3389/fnagi.2015.00195. eCollection 2015.
- Background: PubMed 7114808Mesulam MM. Slowly progressive aphasia without generalized dementia. Ann Neurol. 1982 Jun;11(6):592-8. doi: 10.1002/ana.410110607.
- Background: PubMed 30186225Montembeault M, Brambati SM, Gorno-Tempini ML, Migliaccio R. Clinical, Anatomical, and Pathological Features in the Three Variants of Primary Progressive Aphasia: A Review. Front Neurol. 2018 Aug 21;9:692. doi: 10.3389/fneur.2018.00692. eCollection 2018.
- Background: PubMed 21325651Gorno-Tempini ML, Hillis AE, Weintraub S, Kertesz A, Mendez M, Cappa SF, Ogar JM, Rohrer JD, Black S, Boeve BF, Manes F, Dronkers NF, Vandenberghe R, Rascovsky K, Patterson K, Miller BL, Knopman DS, Hodges JR, Mesulam MM, Grossman M. Classification of primary progressive aphasia and its variants. Neurology. 2011 Mar 15;76(11):1006-14. doi: 10.1212/WNL.0b013e31821103e6. Epub 2011 Feb 16.
- Background: PubMed 29213828Carthery-Goulart MT, da Silveira ADC, Machado TH, Mansur LL, Parente MAMP, Senaha MLH, Brucki SMD, Nitrini R. Nonpharmacological interventions for cognitive impairments following primary progressive aphasia: a systematic review of the literature. Dement Neuropsychol. 2013 Jan-Mar;7(1):122-131. doi: 10.1590/S1980-57642013DN70100018.
- Background: PubMed 17125807Bialystok E, Craik FI, Freedman M. Bilingualism as a protection against the onset of symptoms of dementia. Neuropsychologia. 2007 Jan 28;45(2):459-64. doi: 10.1016/j.neuropsychologia.2006.10.009. Epub 2006 Nov 27.
- Background: PubMed 28322905Alladi S, Bak TH, Shailaja M, Gollahalli D, Rajan A, Surampudi B, Hornberger M, Duggirala V, Chaudhuri JR, Kaul S. Bilingualism delays the onset of behavioral but not aphasic forms of frontotemporal dementia. Neuropsychologia. 2017 May;99:207-212. doi: 10.1016/j.neuropsychologia.2017.03.021. Epub 2017 Mar 18.
- Background: PubMed 24198291Alladi S, Bak TH, Duggirala V, Surampudi B, Shailaja M, Shukla AK, Chaudhuri JR, Kaul S. Bilingualism delays age at onset of dementia, independent of education and immigration status. Neurology. 2013 Nov 26;81(22):1938-44. doi: 10.1212/01.wnl.0000436620.33155.a4. Epub 2013 Nov 6.
- Background: PubMed 32881346de Leon J, Grasso SM, Welch A, Miller Z, Shwe W, Rabinovici GD, Miller BL, Henry ML, Gorno-Tempini ML. Effects of bilingualism on age at onset in two clinical Alzheimer's disease variants. Alzheimers Dement. 2020 Dec;16(12):1704-1713. doi: 10.1002/alz.12170. Epub 2020 Sep 3.
- Background: PubMed 30640254Costa AS, Jokel R, Villarejo A, Llamas-Velasco S, Domoto-Reilley K, Wojtala J, Reetz K, Machado A. Bilingualism in Primary Progressive Aphasia: A Retrospective Study on Clinical and Language Characteristics. Alzheimer Dis Assoc Disord. 2019 Jan-Mar;33(1):47-53. doi: 10.1097/WAD.0000000000000288.
- Background: PubMed 34827370Grasso SM, Pena ED, Kazemi N, Mirzapour H, Neupane R, Bonakdarpour B, Gorno-Tempini ML, Henry ML. Treatment for Anomia in Bilingual Speakers with Progressive Aphasia. Brain Sci. 2021 Oct 20;11(11):1371. doi: 10.3390/brainsci11111371.
- Individual participant dataSharing planned: Yes. Data generated from this project will be shared via peer reviewed journal publications as well as through national and international conferences. All peer-reviewed manuscripts will be made available via PubMed Central, in adherence to the NIH Public Access Policy. Intervention protocols, de-identified summary data, and software code/scripts used for data analysis will be made publicly available upon publication of trial results. De-identified data from individual participants may be made available to the scientific community with approved data use and sharing agreements between the University of Texas, Hospital Sant Pau, Hospital Clínic de Barcelona, and requesting institutions or entities, consistent with institution policy.
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Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Nizubaglustat (AZ-3102) in Patients With GM2 Gangliosidosis or Niemann-Pick Type C Disease
GM2 Gangliosidosis, Niemann-Pick Type C Disease
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.
Stephanie M Grasso, Ph.D principal investigator
University of Texas at Austin
Miguel Ángel Santos Santos, MD, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Implemented Script Training for Aphasia (VISTA) and Lexical Retrieval Training (LRT) in people with Primary Progressive Aphasia and Dementia, run by Stephanie Grasso at 3 sites in 2 countries.
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 5 inclusion and 6 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 10 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 3 sites in Spain, 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?
Contact Camille Wagner Rodríguez, M.S., CCC-SLP (512-471-4119, wagner.camille@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent correct intelligible words from trained/untrained scripts (time frame: Pre-phase 1, post-phase1/pre-phase 2 (4.5 weeks from treatment onset), post-phase 2 (9 weeks from treatment onset), 6 months and 1 year 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 NCT05741853, which also lists 16 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 10 Jun 2026.