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Speech Pattern Evaluation and Analysis for Knowledge of AD

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06230783
Acronym
SPEAK-AD
Enrollment
165
Registered
2024-01-30
Start date
2025-01-22
Completion date
2029-02-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wisconsin Alzheimer's Disease Research Center, Wisconsin Registry for Alzheimer's Prevention

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.

Interventions

OTHERTalkTracker

Participants will be asked to complete the speech collection procedures remotely/at home once per week for 8 weeks. The 8-week period of weekly remote speech collection will take place yearly for a total of 3 years. At the end of each 8-week study period for years 1-3, participants will complete a survey that asks questions about how easy/difficult the application was to use, how frustrated they felt using the application, and other usability questions.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER
Arizona State University
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Usability of remote at-home speech collection - objective3 yearsUsability 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 collection3 yearsFeasibility will be measured through numbers of retention, adherence, and accrual.
Usability of remote at-home speech collection - subjective3 yearsSubjective 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

MeasureTime frameDescription
Correlation between in-clinic speech metrics and remote at-home speech metrics3 yearsCorrelation 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.
Correlations between metrics from remote at-home speech and plasma amyloid-beta (pTau-217)3 yearsCorrelations 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

Countries

United States

Contacts

CONTACTLizzy Sielaff
esielaff@wisc.edu608-264-1019
PRINCIPAL_INVESTIGATORKimberly D Mueller, PhD, CCC-SLP

University of Wisconsin, Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026