Speech Pattern Evaluation and Analysis for Knowledge of AD

NCT ID: NCT06230783

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-22

Study Completion Date

2029-02-28

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arizona State University

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly D Mueller, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lizzy Sielaff

Role: CONTACT

608-264-1019

Other Identifiers

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1R01AG082052-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534255

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/GER-AD DEV

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 10/14/2024

Identifier Type: OTHER

Identifier Source: secondary_id

2023-1740

Identifier Type: -

Identifier Source: org_study_id

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