Speech-derived Digital Biomarkers Study

Completed · Not applicable

Conditions studied: Mild Cognitive Impairment (MCI), Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT06994767

Run by

Hackensack Meridian Health

People needed

150

Starts

2025-05-19

Expected to finish

2026-01-09

Last updated by the study team

2026-01-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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