Alzheimer Disease Clinical Trial
Official title:
Cognitive Reserve and Linguistic Resilience in Bilingual Hispanics With Primary Progressive Aphasia
Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA. The overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how "strong" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 30, 2027 |
Est. primary completion date | November 30, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011) - Bilingual in Spanish and Catalan or bilingual in Spanish and English - Different proficiency levels across languages are expected, any prior experience in both languages is acceptable - Intervention study: Score of 15 or higher on the Mini-Mental State Examination - Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of 10 or higher on the Mini-Mental State Examination Exclusion Criteria: - Other central nervous system or medical diagnosis that can cause symptoms - Other psychiatric diagnosis that can cause symptoms - Significant, uncorrected visual or hearing impairment that would interfere with participation - Prominent initial non-speech-language impairments (cognitive, behavioral, motoric) - Intervention Study: Score of less than 15 on the Mini-Mental State Examination - Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of less than 10 on the Mini-Mental State Examination |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic de Barcelona | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
United States | University of Texas at Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona |
United States, Spain,
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de Leon J, Grasso SM, Welch A, Miller Z, Shwe W, Rabinovici GD, Miller BL, Henry ML, Gorno-Tempini ML. Effects of bilingualism on age at onset in two clinical Alzheimer's disease variants. Alzheimers Dement. 2020 Dec;16(12):1704-1713. doi: 10.1002/alz.12170. Epub 2020 Sep 3. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Post-treatment Communication Survey | Survey characterizing perceived response to treatment. Scale scale options are as follows: "a lot worse", "worse", "somewhat worse", "unchanged", "somewhat better", "better", and "a lot better." There are seven levels with "a lot worse" being the lowest rating and "a lot better" being the best rating. | Post-treatment (approximately 6-12 weeks after treatment onset) | |
Primary | Percent correct intelligible words from trained/untrained scripts | Percent of intelligible, scripted words for trained scripts and untrained scripts | Pre-phase 1, post-phase1/pre-phase 2 (4.5 weeks from treatment onset), post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment | |
Primary | Percent correct spoken naming of trained/untrained nouns | Percent of correctly named trained pictured items and untrained pictured items | Pre-phase 1, post-phase1/pre-phase 2 (4.5 weeks from treatment onset), post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment | |
Secondary | Aphasia Impact Questionnaire (AIQ) | Patient reported outcome measure for use with people with aphasia comprising three sections: activities, participation and emotional state/wellbeing. Uses a 5 point pictorial rating scale. The minimum score is 0 (best) and the maximum is 4 (worst). | Pre-phase 1, Post-phase 2 (9 weeks from treatment onset) | |
Secondary | Connected Speech Features: Type-token ratio | Total number of unique words (types) divided by the total number of words (tokens) derived from connected speech samples (script topic probes, picture description, and personal narrative). | Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment | |
Secondary | Connected Speech Features: Mean length of utterance | Average number of words produced per utterance derived from connected speech samples (script topic probes, picture description, and personal narrative). | Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment | |
Secondary | Acoustic Features: Articulation Rate | Syllables per second of phonated time derived from connected speech samples (script topic probes, picture description, and personal narrative). | Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment | |
Secondary | Acoustic Features: Speech-to-pause time | Phonated time divided by pause time in the sample derived from connected speech samples (script topic probes, picture description, and personal narrative). | Pre-phase 1, Post-phase1/pre-phase 2 (4.5 weeks from treatment onset), Post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment |
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