Clinical trial NCT06230783: Speech Pattern Evaluation and Analysis for Knowledge of AD
Official title: Connected Language and Speech Along the Spectrum of ADRD: Digital Assessment and Monitoring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wisconsin Alzheimer's Disease Research Center
Wisconsin Registry for Alzheimer's Prevention
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: National Institute on Aging (NIA)
First posted: 2024-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled from the WRAP and W-ADRC studies

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Usability of remote at-home speech collection - objective
timeFrame: 3 years
measure: Usability of remote at-home speech collection - objective
timeFrame: 3 years
measure: Feasibility of remote at-home speech collection
timeFrame: 3 years
measure: Feasibility of remote at-home speech collection
timeFrame: 3 years
measure: Feasibility of remote at-home speech collection
timeFrame: 3 years
measure: Usability of remote at-home speech collection - subjective
timeFrame: 3 years
Secondary outcomes:
measure: Correlation between in-clinic speech metrics and remote at-home speech metrics
timeFrame: 3 years
measure: Correlations between metrics from remote at-home speech and plasma amyloid-beta (pTau-217)
timeFrame: 3 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kimberly D Mueller, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: