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NCT06994767 | RECRUITING | Mild Cognitive Impairment (MCI)

Speech-derived Digital Biomarkers Study
Sponsor:

Hackensack Meridian Health

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.

Condition or disease

Mild Cognitive Impairment (MCI)

Alzheimer Disease

Intervention/treatment

The Canary Application

Phase

NA

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
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Speech-derived Digital Biomarkers for Assessing Mild Cognitive Impairment and Alzheimer's Disease Diagnosis Accuracy
Actual Study Start Date : 2025-05-19
Estimated Primary Completion Date : 2026-05-19
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
  • * 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
Speech-derived Digital Biomarkers Study

Location Details

NCT06994767

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How to Participate

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Locations

RECRUITING

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601