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Speech Pattern Evaluation and Analysis for Knowledge of AD

Recruiting
Conditions
Wisconsin Alzheimer's Disease Research Center
Wisconsin Registry for Alzheimer's Prevention
Registration Number
NCT06230783
Lead Sponsor
University of Wisconsin, Madison
Brief Summary

The goal of this observational study is to validate changes in speech as a measure of cognition in individuals at increased risk of Alzheimer's disease and related dementias (ADRD). This study aims to clarify how speech may be affected by Alzheimer's disease.

Participants will complete speech collection sessions and a survey at home using an iPad. Participants can expect to be in the study for 3 years.

Detailed Description

Digital technology, including recorded speech, has the capability of providing a wealth of information about early changes to cognition and communication associated with developing Alzheimer's disease pathology, with the potential for highly accessible, yet low-burden measurement. In this project, researchers will recruit a subset of participants from two longitudinal, observational cohort studies enriched for individuals at risk for or living with Alzheimer's disease to record their speech at home with a mobile device, longitudinally. Our interdisciplinary team will then validate digital markers across all stages of Alzheimer's Disease and Related Dementias (ADRD), including the prodromal phase, and can enhance sensitivity and specificity of speech metrics while contributing valuable information about remote, noninvasive, and accessible assessment and disease monitoring.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
150
Inclusion Criteria
  • Must be enrolled in the Wisconsin Alzheimer's Disease Research Center (W-ADRC) Clinical Core or IMPACT studies, or in the Wisconsin Registry for Alzheimer's Prevention (WRAP)
  • Cognitively unimpaired or have a diagnosis of Mild Cognitive Impairment (MCI)
  • Ages 40-80 years
  • Completion of a W-ADRC or WRAP study visit within the past or upcoming 12 months
  • Have provided W-ADRC or WRAP with blood plasma Alzheimer's Disease
Exclusion Criteria
  • Not actively enrolled in W-ADRC or WRAP
  • Diagnosis of dementia
  • Impaired capacity or unwilling to consent
  • Major neurological conditions
  • Speech disorders

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Usability of remote at-home speech collection - objective3 years

Usability will be measured objectively through the TalkTracker mobile application by obtaining compliance metric of time to completion.

Feasibility of remote at-home speech collection3 years

Feasibility will be measured through identification of productive recruitment methods.

Usability of remote at-home speech collection - subjective3 years

Subjective measurement usability will be assessed through the System Usability Scale (SUS) given to participants after each 8-week completion period. The SUS is a 7 item questionnaire, with a range of 1 to 5 (1 = strongly disagree, 5 = strongly agree). Higher scores on questions 1, 3, 5 and 7 indicate lower usability. Higher scores on questions 2, 4 and 6 indicate higher usability.

Secondary Outcome Measures
NameTimeMethod
Correlations between metrics from remote at-home speech and plasma amyloid-beta (pTau-217)3 years

Correlations will be determined using mixed effects models examining change in speech measures over time with plasma amyloid-beta, covarying for age, sex and genetic risk factors

Correlation between in-clinic speech metrics and remote at-home speech metrics3 years

Correlation between in-clinic versus at-home speech samples will be measured by calculating the inter-class correlation and standard error of measurement on speech measures of interest (content information units, semantic relevance, words per minute). Determination of variance between in-person and at-home speech samples will be evaluated by analysis of covariance accounting for age, sex, education, and cognitive status.

Trial Locations

Locations (1)

University of Wisconsin

🇺🇸

Madison, Wisconsin, United States

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