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Preventing Language Decline in Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02541097
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Regina Jokel, Baycrest

Brief 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 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.


Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia Behavioral: Language therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Language Decline in Dementia
Study Start Date : May 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : January 31, 2019


Arm Intervention/treatment
Active Comparator: Language therapy-Individual treatment
Participants will receive intervention for naming impairment based on either phonological or semantic cues.
Behavioral: Language therapy
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.

Active Comparator: Language therapy-Group treatment
Following the individual therapy, participants will be randomly assigned to either verbal or non-verbal group
Behavioral: Language therapy
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.




Primary Outcome Measures :
  1. Naming accuracy measured with standard naming tests (e.g., BNT) [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541097


Locations
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Canada, Ontario
Baycrest Health Sciences
Toronto, Ontario, Canada, M6A 2E1
Sponsors and Collaborators
Baycrest
Investigators
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Principal Investigator: Regina Jokel Rotman Research Institute, Baycrest and University of Toronto
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Responsible Party: Regina Jokel, Clinician Associate, Baycrest
ClinicalTrials.gov Identifier: NCT02541097    
Other Study ID Numbers: NPSASA-15-362999
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only de-identified group data will be published
Additional relevant MeSH terms:
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Dementia
Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases