Primary Progressive AphasiaNCT02541097
Preventing Language Decline in Dementia
A study testing Language therapy in people with Primary Progressive Aphasia, run by Baycrest at 1 site in Canada.
Trial summary
This study will establish factors fundamental to the improvement in communication and quality of life for people with dementia known as primary progressive aphasia (PPA). PPA is a type of dementia in which language declines but other cognitive skills (including memory) are preserved in the first several years after… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Progressive Aphasia
- What is being tested?
- Language therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- diagnosis of PPA
- fluent in English
- able to see and hear
- able to participate in individual and group sessions
- willing to travel to sessions
- physically independent (if assistive devices needed, must be able to operate them)
Who cannot join
- untreated mental conditions
- neurodegenerative conditions (other than PPA)
Trial locations and contacts
1 site in 1 country.
About this study
This study will establish factors fundamental to the improvement in communication and quality of life for people with dementia known as primary progressive aphasia (PPA). PPA is a type of dementia in which language declines but other cognitive skills (including memory) are preserved in the first several years after the onset. This makes those in the initial stages of PPA excellent candidates for treatment and creates a window of time (2-7 years) whereby they can lead independent lives with minimal support. However, currently, no communication therapy is available to people with PPA due to the progressive nature of the disorder and lack of awareness of available options for professionals willing to treat it.
Participants with PPA in our study will receive two kinds of therapy for the words they cannot recall spontaneously, and will be trained to maintain them through social interaction. The type of training will be based on the most successful interventions the investigators provided to people with PPA in our previous work. The investigators expect that successful re-learning of forgotten words and practicing them in a group setting will facilitate retention of communication skills leading to greater personal independence and increased/maintained quality of life for people with PPA. Our study represents natural combination of two novel approaches for PPA that ultimately will lead to lower demands on the health care system.
Read the detailed description
The study will establish factors fundamental to the improvement in communication and quality of life for people with dementia known as primary progressive aphasia (PPA). PPA is a type of dementia in which language declines but other cognitive skills (including memory) are preserved in the first several years after the onset (see Mesulam 1982). This makes those in the initial stages of PPA excellent candidates for treatment and creates a window of time (2-7 years) whereby PPA individuals can lead independent lives with minimal support. However, currently, no communication therapy is available to people with PPA due to the progressive nature of the disorder and lack of awareness of available options for professionals willing to treat it.
Naming impairments are omnipresent in PPA. For this reason, anomia will be the focus of our intervention. Participants with PPA in our study will receive two kinds of therapy for the words they cannot recall spontaneously, and will be trained to maintain them through social interaction. The type of training will be based on the most successful interventions the investigators provided to people with PPA in our previous work (active encoding and errorless lerning). The investigators expect that successful re-learning of forgotten words and practicing them in a group setting will facilitate retention of communication skills leading to greater personal independence and increased/maintained quality of life for people with PPA. half of the cohort (randomly determined) will then participate in a communication group where conversations are encouraged and half will attend "non-verbal" group meetings when they will paint, watch movies and engage in other activities not requiring talking. To evaluate the benefits of practicing the re-learned words in a social setting naming skills will be tested for each participant before and after individual and group interventions.
- Conditions
- Primary Progressive Aphasia
- Being tested
- Language therapy
- Medical subject headings
- Aphasia, Primary Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language therapyBehavioural
Participants will receive semantic and phonological therapy for words they cannot retrieve spontaneously. They will be given an opportunity to practice the words in a group setting.
| Study group | Role | What they receive |
|---|---|---|
| Language therapy-Individual treatment | Active comparator | Participants will receive intervention for naming impairment based on either phonological or semantic cues. Receives: Behavioral: Language therapy |
| Language therapy-Group treatment | Active comparator | Following the individual therapy, participants will be randomly assigned to either verbal or non-verbal group Receives: Behavioral: Language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Naming accuracy measured with standard naming tests (e.g., BNT)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startMay 2016
- Primary completionDec 2018
- Study completion31 Jan 2019
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Jokel, Baycrest
- Investigators
- Regina Jokel, Principal investigator, Rotman Research Institute, Baycrest and University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541097
- Sponsor's protocol ID
- NPSASA-15-362999
- Status last verified
- Jul 2019
- First submitted
- 31 Aug 2015
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only de-identified group data will be published
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Language Decline in Dementia
- ClinicalTrials.gov ID
- NCT02541097
- Acronym / sponsor ID
- NPSASA-15-362999
- Conditions
- Primary Progressive Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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 study will establish factors fundamental to the improvement in communication and quality of life for people with dementia known as primary progressive aphasia (PPA). PPA is a type of dementia in which language declines but other cognitive skills (including memory) are preserved in the first several years after the onset. This makes those in the initial stages of PPA excellent candidates for treatment and creates a window of time (2-7 years) whereby they can lead independent lives with minimal support. However, currently, no communication therapy is available to people with PPA due to the progressive nature of the disorder and lack of awareness of available options for professionals willing to treat it.
Participants with PPA in our study will receive two kinds of therapy for the words they cannot recall spontaneously, and will be trained to maintain them through social interaction. The type of training will be based on the most successful interventions the investigators provided to people with PPA in our previous work. The investigators expect that successful re-learning of forgotten words and practicing them in a group setting will facilitate retention of communication skills leading to greater personal independence and increased/maintained quality of life for people with PPA. Our study represents natural combination of two novel approaches for PPA that ultimately will lead to lower demands on the health care system.
Detailed description
The study will establish factors fundamental to the improvement in communication and quality of life for people with dementia known as primary progressive aphasia (PPA). PPA is a type of dementia in which language declines but other cognitive skills (including memory) are preserved in the first several years after the onset (see Mesulam 1982). This makes those in the initial stages of PPA excellent candidates for treatment and creates a window of time (2-7 years) whereby PPA individuals can lead independent lives with minimal support. However, currently, no communication therapy is available to people with PPA due to the progressive nature of the disorder and lack of awareness of available options for professionals willing to treat it.
Naming impairments are omnipresent in PPA. For this reason, anomia will be the focus of our intervention. Participants with PPA in our study will receive two kinds of therapy for the words they cannot recall spontaneously, and will be trained to maintain them through social interaction. The type of training will be based on the most successful interventions the investigators provided to people with PPA in our previous work (active encoding and errorless lerning). The investigators expect that successful re-learning of forgotten words and practicing them in a group setting will facilitate retention of communication skills leading to greater personal independence and increased/maintained quality of life for people with PPA. half of the cohort (randomly determined) will then participate in a communication group where conversations are encouraged and half will attend "non-verbal" group meetings when they will paint, watch movies and engage in other activities not requiring talking. To evaluate the benefits of practicing the re-learned words in a social setting naming skills will be tested for each participant before and after individual and group interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Language therapy-Individual treatment | Active comparator | Behavioral: Language therapyParticipants will receive intervention for naming impairment based on either phonological or semantic cues. |
| Language therapy-Group treatment | Active comparator | Behavioral: Language therapyFollowing the individual therapy, participants will be randomly assigned to either verbal or non-verbal group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of PPA
- fluent in English
- able to see and hear
- able to participate in individual and group sessions
- willing to travel to sessions
Key exclusion criteria (2 listed)
- untreated mental conditions
- neurodegenerative conditions (other than PPA)
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 |
|---|---|---|
| Language therapyParticipants will receive semantic and phonological therapy for words they cannot retrieve spontaneously. They will be given an opportunity to practice the words in a group setting. | Behavioural | Language therapy-Group treatment, Language therapy-Individual treatment |
Primary outcome
Naming accuracy measured with standard naming tests (e.g., BNT)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No. Only de-identified group data will be published
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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.
Regina Jokel principal investigator
Rotman Research Institute, Baycrest and University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language therapy in people with Primary Progressive Aphasia, run by Baycrest at 1 site in Canada.
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 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Naming accuracy measured with standard naming tests (e.g., BNT) (time frame: 4 months). 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 9 Jul 2019; AzTrials last refreshed its copy on 27 Oct 2026.