Speech Pattern Evaluation and Analysis for Knowledge of AD (SPEAK-AD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wisconsin Alzheimer's Disease Research Center; Wisconsin Registry for Alzheimer's Prevention
• Intervention / Treatment: Other: TalkTracker

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.

• Study Type: Observational
• Enrollment (Estimated): 165

Contacts and Locations

• Study Contact: Name: Lizzy Sielaff; Phone Number: 608-264-1019; Email: esielaff@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin
      • Contact: Leah K Sanson-Miles; Phone Number: 608-262-7467; Email: lsanson@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled from the WRAP and W-ADRC studies

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of remote at-home speech collection - objective	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).	3 years
Usability of remote at-home speech collection - objective	Usability will be measured objectively through the TalkTracker mobile application by obtaining compliance metric of time to completion.	3 years
Feasibility of remote at-home speech collection	Feasibility will be measured through numbers of retention, adherence, and accrual.	3 years
Feasibility of remote at-home speech collection	Feasibility will be measured through sample characteristics, and identification of productive recruitment methods.	3 years
Feasibility of remote at-home speech collection	Feasibility will be measured through identification of productive recruitment methods.	3 years
Usability of remote at-home speech collection - subjective	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between in-clinic speech metrics and remote at-home speech metrics	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.	3 years
Correlations between metrics from remote at-home speech and plasma amyloid-beta (pTau-217)	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	3 years

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Aging (NIA); Arizona State University
• Investigators: Principal Investigator: Kimberly D Mueller, PhD, CCC-SLP, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: 2023-1740; A534255 (Other Identifier: UW Madison); SMPH/MEDICINE/GER-AD DEV (Other Identifier: UW Madison); 1R01AG082052-01 (U.S. NIH Grant/Contract); Protocol Version 2/4/2026 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No