Speech Pattern Evaluation and Analysis for Knowledge of AD

Официальное название

Connected Language and Speech Along the Spectrum of ADRD: Digital Assessment and Monitoring

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (2)

• Correlation between in-clinic speech metrics and remote at-home speech metrics [Срок оценки: 3 years]
• Correlations between metrics from remote at-home speech and plasma amyloid-beta (pTau-217) [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Wisconsin — Madison

Идентификаторы

NCT: NCT06230783 · 2023-1740 · 1R01AG082052-01 · A534255 · SMPH/MEDICINE/GER-AD DEV · Protocol Version 2/4/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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