Spoken Discourse Biomarker of PD Cognitive Impairment

Northwestern University

Status: Completed

Conditions: Parkinson Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05909163

STU00209602

Details and patient eligibility

About

The purpose of this study is to identify unique profiles of speech and language changes that distinguish individuals with Parkinson's disease from adults without Parkinson's disease and individuals with Parkinson's disease with cognitive (e.g., memory, thinking skills) impairment from those without cognitive impairment.

Full description

Aim 1 will characterize PD-MCI (Parkinson's disease mild cognitive impairment), PDN (Parkinson's disease without cognitive impairment), and HA (healthy adult) spoken discourse, cognitive, and motor speech profiles. Phase 2 biomarker development requires robustly characterized cohorts in which to test candidate biomarkers. Using a standardized battery of cognitive, language, and motor speech tests PD participants will be assigned to PD-MCI (single/multi-domain) or PDN groups. The investigators propose collecting spoken discourse samples using standardized elicitation protocols. The same tasks will be extracted from the extant HA database. Researchers will transcribe, code, and analyze discourse samples. Group differences (including sub-analyses for single and multi-domain MCI subtypes), elicitation stimuli effects, and group x stimuli interactions will be examined using multivariate and mixed-design ANOVA procedures.

Aim 2 will develop and evaluate the classification accuracy of an optimally weighted discourse classification function for PD-MCI and PDN. The investigators propose using discriminant function analysis to identify an optimized composite variable that best predicts PD-MCI, PDN, and HA group membership. Sensitivity/specificity analyses, positive/negative predictive values, and receiver operating characteristic curves will be used to evaluate the discourse classification function properties.

The primary endpoint is an optimally weighted discourse function that can classify PD-MCI with > 80% sensitivity/specificity.

Enrollment: 140 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Only individuals with PD will be newly recruited and enrolled as part of the study. Healthy adult data will be extracted from extant databases (publicly available) from NIH-funded studies.

Inclusion Criteria Person with Parkinson's disease without cognitive impairment

• Age 50-90 years
• Diagnosis of idiopathic Parkinson's disease (UK Brain Bank criteria) made by a movement disorders specialist
• Under the care of a movement disorders specialist for a minimum of 1-year duration
• Native monolingual English speaker
• Hoehn & Yahr score between 1.5 and 4
• Grade 10 education, or higher
• Sufficient vision and hearing (aided or unaided) for all experiment tasks
• Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than or equal to 25
• No subjective complaints of cognitive difficulty or word finding issues

Inclusion Criteria Person with Parkinson's disease mild cognitive impairment

• Age 50-90 years
• Diagnosis of idiopathic Parkinson's disease (UK Brain Bank criteria) made by a movement disorders specialist
• Under the care of a movement disorders specialist for a minimum of 1-year duration
• Native monolingual English speaker
• Hoehn & Yahr score between 1.5 and 4
• Grade 10 education, or higher
• Sufficient vision and hearing (aided or unaided) for all experiment tasks
• Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than or equal to 17
• Subjective complaints of cognitive difficulty or word finding issues, without significant impact on activities of daily living

Inclusion Healthy Adults (from extant data base - no new recruiting)

• Age 50-90 years
• Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than or equal to 26
• Native monolingual English speaker
• Grade 10 education, or higher
• Sufficient vision and hearing (aided or unaided) for all experiment tasks

Exclusion criteria

Exclusion Criteria Neurological injury or disease (other than PD for the PD cohort)

• History of unmanaged or untreated depression or major psychiatric illness
• History of deep brain stimulation surgery (DBS)
• Diagnosis of Dementia with Lewy Bodies

Trial design

140 participants in 2 patient groups

Pakinson's disease without cognitive impairment

Description:

* Age 50-90 years * Diagnosis of idiopathic Parkinson's disease (UK Brain Bank criteria) made by a movement disorders specialist * Under the care of a movement disorders specialist for a minimum of 1-year duration * Native monolingual English speaker * Hoehn \& Yahr score between 1.5 and 4 * Grade 10 education, or higher * Sufficient vision and hearing (aided or unaided) for all experiment tasks * Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than or equal to 25 * No subjective complaints of cognitive difficulty or word finding issues

Pakinson's disease with cognitive impairment

Description:

* Age 50-90 years * Diagnosis of idiopathic Parkinson's disease (UK Brain Bank criteria) made by a movement disorders specialist * Under the care of a movement disorders specialist for a minimum of 1-year duration * Native monolingual English speaker * Hoehn \& Yahr score between 1.5 and 4 * Grade 10 education, or higher * Sufficient vision and hearing (aided or unaided) for all experiment tasks * Montreal Cognitive Assessment (or MoCA-converted MMSE score) greater than or equal to 17 * Subjective complaints of cognitive difficulty or word finding issues, without significant impact on activities of daily living