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Clinical Trials/NCT06230783
NCT06230783
Recruiting
Not Applicable

Connected Language and Speech Along the Spectrum of ADRD: Digital Assessment and Monitoring

University of Wisconsin, Madison1 site in 1 country165 target enrollmentJanuary 22, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wisconsin Alzheimer's Disease Research Center
Sponsor
University of Wisconsin, Madison
Enrollment
165
Locations
1
Primary Endpoint
Usability of remote at-home speech collection - subjective
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2025
End Date
February 1, 2029
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Usability of remote at-home speech collection - subjective

Time Frame: 3 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.

Usability of remote at-home speech collection - objective

Time Frame: 3 years

Usability will be measured objectively through the TalkTracker mobile application by obtaining compliance metrics (number of tasks completed, total number of errors, number of help requests).

Feasibility of remote at-home speech collection

Time Frame: 3 years

Feasibility will be measured through numbers of retention, adherence, and accrual.

Secondary Outcomes

  • Correlations between metrics from remote at-home speech and plasma amyloid-beta (pTau-217)(3 years)
  • Correlation between in-clinic speech metrics and remote at-home speech metrics(3 years)

Study Sites (1)

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