Preventing Language Decline in Dementia

July 8, 2019 updated by: Regina Jokel, Baycrest

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A 2E1
        • Baycrest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Naming accuracy measured with standard naming tests (e.g., BNT)
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baycrest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Regina Jokel, Rotman Research Institute, Baycrest and University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NPSASA-15-362999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Only de-identified group data will be published

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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