Skip to main content
OpenTrials
Completed

NCT Number: NCT06994767

Speech-derived Digital Biomarkers Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • For the control group: Without diagnosis of MCI or Alzheimer's or other types of dementia
  • 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

Treatment and study plan

The Canary Application

Other

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.

Other names: Validation

Primary outcomes

  1. The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosis

    Time frame: 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.

  2. The primary objective of the study is to assess the specificity of vocal biomarkers in patients with MCI and AD diagnosis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • Canary Speech Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.