Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT06230783

Conditions

Wisconsin Alzheimer's Disease Research Center

Wisconsin Registry for Alzheimer's Prevention

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

TalkTracker

Study Details

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.

Conditions

Wisconsin Alzheimer's Disease Research Center

Wisconsin Registry for Alzheimer's Prevention

Study ID

NCT06230783

Start date

Jan 22, 2025

Status verified date

Mar, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Enrollment

165 participants

Anticipated

Interventions and Outcome Measures

Interventions

TalkTracker

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.

Primary outcome measure

  • Usability of remote at-home speech collection - objective [ Time Frame: 3 years ]
  • Usability of remote at-home speech collection - objective [ Time Frame: 3 years ]
  • Feasibility of remote at-home speech collection [ Time Frame: 3 years ]
  • Feasibility of remote at-home speech collection [ Time Frame: 3 years ]
  • Feasibility of remote at-home speech collection [ Time Frame: 3 years ]
  • Usability of remote at-home speech collection - subjective [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Lizzy Sielaff

608-264-1019esielaff@wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-03-12.