NCT02541097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

2.6 years

First QC Date

August 31, 2015

Last Update Submit

July 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Naming accuracy measured with standard naming tests (e.g., BNT)

    4 months

Study Arms (2)

Language therapy-Individual treatment

ACTIVE COMPARATOR

Participants will receive intervention for naming impairment based on either phonological or semantic cues.

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

Behavioral: Language therapy

Interventions

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.

Language therapy-Group treatmentLanguage therapy-Individual treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • untreated mental conditions
  • neurodegenerative conditions (other than PPA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada

Location

MeSH Terms

Conditions

Aphasia, Primary Progressive

Interventions

Language Therapy

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAphasiaSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Regina Jokel

    Rotman Research Institute, Baycrest and University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Associate

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 4, 2015

Study Start

May 1, 2016

Primary Completion

December 1, 2018

Study Completion

January 31, 2019

Last Updated

July 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Only de-identified group data will be published

Locations