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Behavioral Intervention
Speech-Language Therapy for Primary Progressive Aphasia (CB3 Trial)
Phase 2
Recruiting
Led By Emily Roglaski, PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18+ years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 assessment time points through study completion (up to 18 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate the effects of two different treatments for adults with mild-moderate Primary Progressive Aphasia (PPA). The goal is to determine how speech-language therapy can improve communication abilities in individuals
Who is the study for?
This trial is for adults with mild to moderate Primary Progressive Aphasia (PPA), including conditions like Pick's Disease and Frontotemporal Dementia. Participants should be able to engage in speech-language therapy.
What is being tested?
The study compares two evidence-based speech-language therapies using a randomized controlled design, aiming to understand their impact on communication abilities in individuals with PPA.
What are the potential side effects?
Since the interventions are non-medical therapies focused on improving communication, no traditional side effects like those seen with medications are expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 assessment time points through study completion (up to 18 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 assessment time points through study completion (up to 18 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Communication Participation
Change in Communication Participation Person Centered Goals
Montgomery Burden Inventory (MBI)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Communication Bridge™Experimental Treatment1 Intervention
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Group II: Evidence-Based Impairment FocusedActive Control1 Intervention
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Communication Bridge™
2018
N/A
~200
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,781 Total Patients Enrolled
University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
839,936 Total Patients Enrolled
Western University, CanadaOTHER
254 Previous Clinical Trials
59,086 Total Patients Enrolled
Emily Roglaski, PhDPrincipal InvestigatorProfessor of Neurology
1 Previous Clinical Trials
12 Total Patients Enrolled