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Speech-derived Digital Biomarkers Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06994767
Enrollment
150
Registered
2025-05-29
Start date
2025-05-19
Completion date
2026-01-09
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Mild Cognitive Impairment (MCI)

Keywords

Vocal biomarkers, Mild Cognitive Impairment, Alzheimer's Disease, Deep machine learning, Artificial Intelligence application

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.

Interventions

OTHERThe 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.

Sponsors

Hackensack Meridian Health
Lead SponsorOTHER
Canary Speech Inc.
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosisUpon enrollmentThe 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 diagnosisUpon enrollmentThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026