Analyzing voice characteristics to diagnose cognitive impairment and Alzheimer's disease
Speech-derived Digital Biomarkers for Assessing Mild Cognitive Impairment and Alzheimer's Disease Diagnosis Accuracy
This study tests a new app that listens to people's voices to see if it can help diagnose mild cognitive impairment and Alzheimer's disease more accurately than doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Hackensack Meridian Health Academic / other |
| Locations | 1 site (Hackensack, New Jersey) |
| Trial ID | NCT06994767 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an application that analyzes vocal biomarkers to diagnose mild cognitive impairment (MCI) and Alzheimer's disease (AD). It compares the application's diagnostic results with those of clinicians to assess its sensitivity and specificity. Participants will provide voice recordings and complete clinically validated surveys to determine their disease status. The primary outcome is the accuracy of the application's diagnosis in relation to the physician's clinical diagnosis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and above who have been diagnosed with mild cognitive impairment or Alzheimer's disease by a physician.
Not a fit: Patients under 50 years old or those with conditions that affect voice characteristics, such as Parkinson's or Huntington's disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this application could provide a non-invasive and efficient method for diagnosing mild cognitive impairment and Alzheimer's disease.
How similar studies have performed: Other studies utilizing vocal biomarkers for cognitive assessment have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hackensack, New Jersey
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Sakshi Jain, MD — Hackensack Meridian Health
- Study coordinator: Susan Dara, MPH
- Email: susan.dara@hmhn.org
- Phone: 5519965180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.