Primary Progressive AphasiaSCED-APPvsNCT04957537
Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia
A study testing semantic therapy and semantic re-education in people with Primary Progressive Aphasia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This project aims to measure the effect of a semantic rehabilitation protocol for patients with primary progressive semantic aphasia and using the SCED methodology. 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?
- semantic therapy and semantic re-education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2021to 20 Mar 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of primary progressive semantic aphasia according to the criteria of Gorno-Tempini et al (2011) (Appendix A)
- Being in the mild to moderate stage of dementia (MMSE score between 10 and 28) (Crum et al., 1993; Derouesné et al., 1999)
- Common French
- Being affiliated to a social security scheme
- Being over the age of 18 years old
Who cannot join
- Have significant uncorrected visual and/or hearing impairment
- Have a history of brain injuries, major head trauma
- Have untreated psychiatric disorders
- Have significant motor and/or comprehension problems that make it impossible to take part in the study
- Chronical use of drugs and/or alcohol
- Under guardians or curators
- Severe depression (Beck's depression scale score > 9) (Beck \& al., 1961)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Toulouse
Toulouse
Jérémie Pariente, MD, PhD, 05.61.77.95.02, pariente.j@chu-toulouse.fr
About this study
Official title: Evaluation of the Effect of a Semantic Rehabilitation in Patients in the Mild to Moderate Stage of Primary Progressive Semantic Aphasia : a SCED Study
This project aims to measure the effect of a semantic rehabilitation protocol for patients with primary progressive semantic aphasia and using the SCED methodology.
Read the detailed description
The damage on the semantic system is at the heart of the clinical picture of semantic primary progressive aphasia (PPA), a neuro-evolutionary pathology. In other words, patients gradually lose access to concepts, general knowledge, word memory and meaning. In the absence of effective pharmacological treatment to reduce the symptoms evoked by patients and improve their quality of life, the arguments in favour of speech and language therapy are multiplying.
Numerous lexico-semantic multimodal indication therapies have been described in scientific studies. The most studied is semantic rehabilitation through the analysis of semantic features, which has shown its effectiveness in the context of vascular and post-traumatic aphasia.
However, there are only few studies and applications in neuro-evolutionary pathologies such as semantic PPA and those studies are complicated by methodological biases. It has been shown that relearned knowledge is more likely to be retained and transferred to everyday life (generalisation) if the material used is specific to the needs of each individual. Given the heterogeneity of clinical profiles in neuro-evolving pathologies and the inter-individual variability, the personalised approach should be favoured.
To evaluate the effect of semantic therapy in patients with semantic PPA, this study therefore proposes to use the SCED (Single Case Experimental Design) methodology. In addition to allowing an individual analysis, this methodology has the advantage of corresponding to a high level of evidence due to the acquisition of repeated measures and the randomisation of the introduction of the treatment.
- Conditions
- Primary Progressive Aphasia
- Being tested
- semantic therapy and semantic re-education
- Keywords
- Semantic primary progressive aphasia, semantic variant (svPPA), speech therapy, anomia, metacognition, Single Case Experimental Design, technology, naming, speed of lexical access
- Medical subject headings
- Aphasia, Primary Progressive, Pick Disease of the Brain, Communication Disorders, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semantic therapy and semantic re-educationBehavioural
Patients will be followed over two periods "Phase A (randomized, 6 to 8 weeks) - Phase B (5 weeks)".
Phase A : Baseline Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 6 to 8 weeks (i.e. 18 to 24 sessions) depending on the randomisation, at the rate of 3 speech therapy sessions of 45 minutes per week.
Phase B : Semantic re-education The sessions will consist of training based on the analysis of semantic traits (Coustaut, 2019). This phase will last 5 weeks (i.e. 15 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week.
In accordance with the application of the SCED methodology, repeated measurements will be carried out every second session during phases A and B. They will consist of proposing the oral naming task (lasting 10 minutes).
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks phase A | Other | According to SCED methodology design :
Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 6 weeks (i.e. 18 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week. Receives: Behavioral: semantic therapy and semantic re-education |
| 8 weeks phase A | Other | According to SCED methodology design :
Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 8 weeks (i.e. 24 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week. Receives: Behavioral: semantic therapy and semantic re-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in speaking
To evaluate speaking accuracy, the study team will assess the number of correct items recovered by the patient when performing a specific naming task before the rehabilitation.
The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.
Measured: Baseline (before phase A)
Performance in speaking
To evaluate speaking response time, the study team will assess the rate at which items are recovered by the patient when performing a specific naming task before the rehabilitation.
The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.
Measured: Baseline (before phase A)
Performance in speaking
To evaluate speaking accuracy, the study team will assess the number of correct items repeated by the patient when performing a specific naming task after the rehabilitation.
The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.
Measured: immediately after the intervention (after phase B)
Performance in speaking
To evaluate speaking response time, the study team will assess the rate at which items are recovered by the patient when performing a specific naming task after rehabilitation.
The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.
Measured: immediately after the intervention (after phase B)
Secondary outcomes (1)
Maintenance of the performance in speaking
Number of correct items recovered by the patient when performing a specific naming task 1 month after the end of the intervention.
The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.
This will be compared to the number of items correctly recovered at the end of the rehabilitation (corresponding to outcome 3 here).
Measured: 1 month after the end of the intervention (after phase B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start20 Sep 2021
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Mar 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, monocentric, prospective, randomised, controlled research. Single Case Experimental Design" type study in multiple baselines with 2 successive phases (A-B design) for each patient. For each subject, phase A constitutes the baseline (6 to 8 weeks), phase B is characterised by semantic rehabilitation (5 weeks). The beginning of the intervention will be sequential and the duration of the baseline will be randomised for each patient.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémie PARIENTE, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957537
- Sponsor's protocol ID
- RC31/21/0215
- Acronym
- SCED-APPvs
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2021
- Last updated
- 11 Aug 2026
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Semantic Rehabilitation in Patients in the Mild to Moderate Stage of Primary Progressive Semantic Aphasia : a SCED Study
- ClinicalTrials.gov ID
- NCT04957537
- Acronym / sponsor ID
- SCED-APPvs / RC31/21/0215
- Conditions
- Primary Progressive Aphasia
- Keywords
- Semantic primary progressive aphasia, semantic variant (svPPA), speech therapy, anomia, metacognition, Single Case Experimental Design, technology, naming
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 12 Jul 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.
This project aims to measure the effect of a semantic rehabilitation protocol for patients with primary progressive semantic aphasia and using the SCED methodology.
Detailed description
The damage on the semantic system is at the heart of the clinical picture of semantic primary progressive aphasia (PPA), a neuro-evolutionary pathology. In other words, patients gradually lose access to concepts, general knowledge, word memory and meaning. In the absence of effective pharmacological treatment to reduce the symptoms evoked by patients and improve their quality of life, the arguments in favour of speech and language therapy are multiplying.
Numerous lexico-semantic multimodal indication therapies have been described in scientific studies. The most studied is semantic rehabilitation through the analysis of semantic features, which has shown its effectiveness in the context of vascular and post-traumatic aphasia.
However, there are only few studies and applications in neuro-evolutionary pathologies such as semantic PPA and those studies are complicated by methodological biases. It has been shown that relearned knowledge is more likely to be retained and transferred to everyday life (generalisation) if the material used is specific to the needs of each individual. Given the heterogeneity of clinical profiles in neuro-evolving pathologies and the inter-individual variability, the personalised approach should be favoured.
To evaluate the effect of semantic therapy in patients with semantic PPA, this study therefore proposes to use the SCED (Single Case Experimental Design) methodology. In addition to allowing an individual analysis, this methodology has the advantage of corresponding to a high level of evidence due to the acquisition of repeated measures and the randomisation of the introduction of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, monocentric, prospective, randomised, controlled research. Single Case Experimental Design" type study in multiple baselines with 2 successive phases (A-B design) for each patient. For each subject, phase A constitutes the baseline (6 to 8 weeks), phase B is characterised by semantic rehabilitation (5 weeks). The beginning of the intervention will be sequential and the duration of the baseline will be randomised for each patient.
| Arm | Type | Receives |
|---|---|---|
| 6 weeks phase A | Other | Behavioral: semantic therapy and semantic re-educationAccording to SCED methodology design : Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 6 weeks (i.e. 18 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week. |
| 8 weeks phase A | Other | Behavioral: semantic therapy and semantic re-educationAccording to SCED methodology design : Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 8 weeks (i.e. 24 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of primary progressive semantic aphasia according to the criteria of Gorno-Tempini et al (2011) (Appendix A)
- Being in the mild to moderate stage of dementia (MMSE score between 10 and 28) (Crum et al., 1993; Derouesné et al., 1999)
- Common French
- Being affiliated to a social security scheme
- Being over the age of 18 years old
Key exclusion criteria (7 listed)
- Have significant uncorrected visual and/or hearing impairment
- Have a history of brain injuries, major head trauma
- Have untreated psychiatric disorders
- Have significant motor and/or comprehension problems that make it impossible to take part in the study
- Chronical use of drugs and/or alcohol
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 |
|---|---|---|
| semantic therapy and semantic re-educationPatients will be followed over two periods "Phase A (randomized, 6 to 8 weeks) - Phase B (5 weeks)". Phase A : Baseline Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 6 to 8 weeks (i.e. 18 to 24 sessions) depending on the randomisation, at the rate of 3 speech therapy sessions of 45 minutes per week. Phase B : Semantic re-education The sessions will consist of training based on the analysis of semantic traits (Coustaut, 2019). This phase will last 5 weeks (i.e. 15 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week. In accordance with the application of the SCED methodology, repeated measurements will be carried out every second session during phases A and B. They will consist of proposing the oral naming task (lasting 10 minutes). | Behavioural | 6 weeks phase A, 8 weeks phase A |
Primary outcome
Performance in speaking
Time frame: Baseline (before phase A)
To evaluate speaking accuracy, the study team will assess the number of correct items recovered by the patient when performing a specific naming task before the rehabilitation. The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.
Performance in speaking
Time frame: Baseline (before phase A)
To evaluate speaking response time, the study team will assess the rate at which items are recovered by the patient when performing a specific naming task before the rehabilitation. The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.
Performance in speaking
Time frame: immediately after the intervention (after phase B)
To evaluate speaking accuracy, the study team will assess the number of correct items repeated by the patient when performing a specific naming task after the rehabilitation. The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.
Performance in speaking
Time frame: immediately after the intervention (after phase B)
To evaluate speaking response time, the study team will assess the rate at which items are recovered by the patient when performing a specific naming task after rehabilitation. The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.
1 secondary outcome
Maintenance of the performance in speaking
Time frame: 1 month after the end of the intervention (after phase B)
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 11 Aug 2026.
- 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.
Jérémie PARIENTE, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semantic therapy and semantic re-education in people with Primary Progressive Aphasia, run by University Hospital, Toulouse at 1 site in France.
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 7 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Jérémie PARIENTE, MD PhD (0561777686, pariente.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance in speaking (time frame: Baseline (before phase A)). 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 11 Aug 2026.