Status:

RECRUITING

Speech-derived Digital Biomarkers Study

Lead Sponsor:

Hackensack Meridian Health

Collaborating Sponsors:

Canary Speech Inc.

Conditions:

Mild Cognitive Impairment (MCI)

Alzheimer Disease

Eligibility:

All Genders

50+ years

Phase:

NA

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 wh...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 19 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06994767

Start Date

May 19 2025

End Date

December 31 2026

Last Update

January 8 2026

Active Locations (1)

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1

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601