Speech-derived Digital Biomarkers Study

January 12, 2026 updated by: Hackensack Meridian Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mild Cognitive Impairment (MCI)
Patients with a mild congitive impairment
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.
Other Names:
  • Validation
Experimental: Alzheimer's Disease
Patients with an Alzheimer's Disease diagnosis
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.
Other Names:
  • Validation
Active Comparator: Healthy Volunteers
Patients without a diagnosis of MCI or Alzheimer's, or other types of dementia
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.
Other Names:
  • Validation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon enrollment
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.
Upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Collaborators

Canary Speech Inc.

Investigators

  • Principal Investigator: Sakshi Jain, MD, Hackensack Meridian Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2025

Primary Completion (Actual)

January 9, 2026

Study Completion (Actual)

January 9, 2026

Study Registration Dates

First Submitted

May 13, 2025

First Submitted That Met QC Criteria

May 20, 2025

First Posted (Actual)

May 29, 2025

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2024-0418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mild Cognitive Impairment (MCI)

Clinical Trials on The Canary Application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe