Wisconsin Alzheimer's Disease Research CenterSPEAK-ADNCT06230783
Speech Pattern Evaluation and Analysis for Knowledge of AD
An observational study of Wisconsin Alzheimer's Disease Research Center and Wisconsin Registry for Alzheimer's Prevention, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Wisconsin Alzheimer's Disease Research Center, Wisconsin Registry for Alzheimer's Prevention
- What is being tested?
- TalkTracker
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2025to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be enrolled from the WRAP and W-ADRC studies
Who may be able to join
- 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
Who cannot join
- Not actively enrolled in W-ADRC or WRAP
- Diagnosis of dementia
- Impaired capacity or unwilling to consent
- Major neurological conditions
- Speech disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
About this study
Official title: 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.
Read the 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.
- Conditions
- Wisconsin Alzheimer's Disease Research Center, Wisconsin Registry for Alzheimer's Prevention
- Being tested
- TalkTracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 3 years
Feasibility of remote at-home speech collection
Feasibility will be measured through numbers of retention, adherence, and accrual.
Measured: 3 years
Feasibility of remote at-home speech collection
Feasibility will be measured through sample characteristics, and identification of productive recruitment methods.
Measured: 3 years
Feasibility of remote at-home speech collection
Feasibility will be measured through identification of productive recruitment methods.
Measured: 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.
Measured: 3 years
Secondary outcomes (2)
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.
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start22 Jan 2025
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wisconsin Alzheimer's Disease Research CenterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kimberly D Mueller, PhD, CCC-SLP, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230783
- Sponsor's protocol ID
- 2023-1740
- Other IDs
- 1R01AG082052-01, A534255, SMPH/MEDICINE/GER-AD DEV, Protocol Version 2/4/2026
- Acronym
- SPEAK-AD
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connected Language and Speech Along the Spectrum of ADRD: Digital Assessment and Monitoring
- ClinicalTrials.gov ID
- NCT06230783
- Acronym / sponsor ID
- SPEAK-AD / 2023-1740
- Conditions
- Wisconsin Alzheimer's Disease Research Center, Wisconsin Registry for Alzheimer's Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Arizona State University, National Institute on Aging (NIA)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be enrolled from the WRAP and W-ADRC studies
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Not actively enrolled in W-ADRC or WRAP
- Diagnosis of dementia
- Impaired capacity or unwilling to consent
- Major neurological conditions
- Speech disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalkTrackerParticipants 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. | Other | – |
Primary outcome
Usability of remote at-home speech collection - objective
Time frame: 3 years
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).
Usability of remote at-home speech collection - objective
Time frame: 3 years
Usability will be measured objectively through the TalkTracker mobile application by obtaining compliance metric of time to completion.
Feasibility of remote at-home speech collection
Time frame: 3 years
Feasibility will be measured through numbers of retention, adherence, and accrual.
Feasibility of remote at-home speech collection
Time frame: 3 years
Feasibility will be measured through sample characteristics, and identification of productive recruitment methods.
Feasibility of remote at-home speech collection
Time frame: 3 years
Feasibility will be measured through identification of productive recruitment methods.
Usability of remote at-home speech collection - subjective
Time frame: 3 years
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.
2 secondary outcomes
Correlation between in-clinic speech metrics and remote at-home speech metrics
Time frame: 3 years
Correlations between metrics from remote at-home speech and plasma amyloid-beta (pTau-217)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly D Mueller, PhD, CCC-SLP principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wisconsin Alzheimer's Disease Research Center and Wisconsin Registry for Alzheimer's Prevention, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lizzy Sielaff (608-264-1019, esielaff@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of remote at-home speech collection - objective (time frame: 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.