Speech-derived Digital Biomarkers Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-19

Study Completion Date

2026-01-09

Brief Summary

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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.

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Detailed Description

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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

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Mild Cognitive Impairment (MCI) Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Mild Cognitive Impairment (MCI)

Patients with a mild congitive impairment

Group Type EXPERIMENTAL

The Canary Application

Intervention Type 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.

Alzheimer's Disease

Patients with an Alzheimer's Disease diagnosis

Group Type EXPERIMENTAL

The Canary Application

Intervention Type 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.

Healthy Volunteers

Patients without a diagnosis of MCI or Alzheimer's, or other types of dementia

Group Type ACTIVE_COMPARATOR

The Canary Application

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Validation

Eligibility Criteria

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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

Exclusion Criteria

* Subject must be able to speak and read with fluency in the English language.

* 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No