Speech-derived Digital Biomarkers Study

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease

• Registration Number: NCT06994767
• Lead Sponsor: Hackensack Meridian Health

Brief Summary

The goal is to assess the accuracy of an application that analyzes voice characteristics to diagnose patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD). The main question is whether the application's diagnosis is the same as the clinician's for MCI and AD patients.

Detailed Description

The study aims to assess the sensitivity and specificity of an application that uses vocal biomarkers to diagnose patients with mild cognitive impairment (MCI) and Alzheimer's disease. The application will use clinically validated survey instruments and voice recordings to determine the disease status of patients with MCI and Alzheimer's disease. The diagnosis developed by the application is the primary outcome variable. To determine the sensitivity and specificity, the application diagnosis will be compared against the physician's clinical diagnosis.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study Start: 2025-05-19
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Primary Completion: 2026-05-19
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Males and females between the ages of 50 and above
• Willing and capable of participating in all aspects of the study
• Willing and capable of giving informed consent
• Diagnosis of MCI or Alzheimer's by the physician
• Subjects are free of any medical condition(s) that, according to exclusion criteria, might audibly affect voice characteristics
• Subject must be able to speak and read with fluency in the English language.

Exclusion Criteria

• All participants below 50 years

• Failure to provide informed consent

• Individuals with the following medical conditions will be excluded:

  i) Parkinson's disease ii) Huntington's disease iii) Cancer and active cancer treatments

• Persons with speech characteristics (heavy accents, slurring, stuttering, etc.) that would interfere with voice recording or voice analysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosis	Upon enrollment	The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the sensitivity, the application diagnosis will be compared against the clinical diagnosis of the physician.
The primary objective of the study is to assess the specificity of vocal biomarkers in patients with MCI and AD diagnosis	Upon enrollment	The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the specificity, the application diagnosis will be compared against the clinical diagnosis of the physician.

Trial Locations

Locations (1)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States