NCT06230783

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
33mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Jan 2025Feb 2029

First Submitted

Initial submission to the registry

January 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

January 22, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

January 19, 2024

Last Update Submit

March 9, 2026

Conditions

Wisconsin Alzheimer's Disease Research CenterWisconsin Registry for Alzheimer's Prevention

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Correlation between in-clinic speech metrics and remote at-home speech metrics

    3 years

  • Correlations between metrics from remote at-home speech and plasma amyloid-beta (pTau-217)

    3 years

Interventions

TalkTrackerOTHER

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.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Not actively enrolled in W-ADRC or WRAP
  • Diagnosis of dementia
  • Impaired capacity or unwilling to consent
  • Major neurological conditions
  • Speech disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

Study Officials

  • Kimberly D Mueller, PhD, CCC-SLP

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lizzy Sielaff

CONTACT

608-264-1019esielaff@wisc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 30, 2024

Study Start

January 22, 2025

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)