- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541097
Preventing Language Decline in Dementia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M6A 2E1
- Baycrest Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- untreated mental conditions
- neurodegenerative conditions (other than PPA)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Language therapy-Individual treatment
Participants will receive intervention for naming impairment based on either phonological or semantic cues.
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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.
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Active Comparator: Language therapy-Group treatment
Following the individual therapy, participants will be randomly assigned to either verbal or non-verbal group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Naming accuracy measured with standard naming tests (e.g., BNT)
Time Frame: 4 months
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4 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Regina Jokel, Rotman Research Institute, Baycrest and University of Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Dementia
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- NPSASA-15-362999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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