Speech-derived Digital Biomarkers Study (NCT06994767) | Clinical Trial Compass
CompletedNot Applicable
Speech-derived Digital Biomarkers Study
United States150 participantsStarted 2025-05-19
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosis
Timeframe: Upon enrollment
2
The primary objective of the study is to assess the specificity of vocal biomarkers in patients with MCI and AD diagnosis