NCT06994767

Speech-derived Digital Biomarkers Study

Speech-derived Digital Biomarkers for Assessing Mild Cognitive Impairment and Alzheimer's Disease Diagnosis Accuracy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment (MCI)
• Alzheimer Disease

Interventions

Type	Name	Description
OTHER	The Canary Application	The CANARY application will use clinically validated survey instruments and voice recordings to measure user MCI status /Alzheimer's data. These tests are designed to evaluate a user's voice characteristics and potentially identify disease-specific patterns.

Timeline

• Start date: 2025-05-19
• Primary completion: 2026-01-09
• Completion: 2026-01-09
• First posted: 2025-05-29
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States