Mild Cognitive Impairment (MCI)NCT06994767
Speech-derived Digital Biomarkers Study
A study testing The Canary Application in people with Mild Cognitive Impairment (MCI) and Alzheimer Disease, run by Hackensack Meridian Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Alzheimer Disease
- What is being tested?
- The Canary Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- All participants below 50 years
- Failure to provide informed consent
- Individuals with the following medical conditions will be excluded:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Speech-derived Digital Biomarkers for Assessing Mild Cognitive Impairment and Alzheimer's Disease Diagnosis Accuracy
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment (MCI), Alzheimer Disease
- Being tested
- The Canary Application
- Keywords
- Vocal biomarkers, Mild Cognitive Impairment, Alzheimer's Disease, Deep machine learning, Artificial Intelligence application
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Canary ApplicationOther
Also called Validation
The CANARY application will use clinically validated survey instruments and voice recordings to measure user MCI status /Alzheimer's data. These tests are designed to evaluate a user's voice characteristics and potentially identify disease-specific patterns.
| Study group | Role | What they receive |
|---|---|---|
| Mild Cognitive Impairment (MCI) | Experimental | Patients with a mild congitive impairment Receives: Other: The Canary Application |
| Alzheimer's Disease | Experimental | Patients with an Alzheimer's Disease diagnosis Receives: Other: The Canary Application |
| Healthy Volunteers | Active comparator | Patients without a diagnosis of MCI or Alzheimer's, or other types of dementia Receives: Other: The Canary Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosis
The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the sensitivity, the application diagnosis will be compared against the clinical diagnosis of the physician.
Measured: Upon enrollment
The primary objective of the study is to assess the specificity of vocal biomarkers in patients with MCI and AD diagnosis
The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the specificity, the application diagnosis will be compared against the clinical diagnosis of the physician.
Measured: Upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start19 May 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canary Speech Inc.
- Responsible party
- Sponsor
- Investigators
- Sakshi Jain, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994767
- Sponsor's protocol ID
- Pro2024-0418
- Status last verified
- Jan 2026
- First submitted
- 13 May 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez-Sanchez F, Meilan JJG, Carro J, Ivanova O. A Prototype for the Voice Analysis Diagnosis of Alzheimer's Disease. J Alzheimers Dis. 2018;64(2):473-481. doi: 10.3233/JAD-180037.
PubMed 29914025Mueller KD, Hermann B, Mecollari J, Turkstra LS. Connected speech and language in mild cognitive impairment and Alzheimer's disease: A review of picture description tasks. J Clin Exp Neuropsychol. 2018 Nov;40(9):917-939. doi: 10.1080/13803395.2018.1446513. Epub 2018 Apr 19.
PubMed 29669461Garcia AM, de Leon J, Tee BL, Blasi DE, Gorno-Tempini ML. Speech and language markers of neurodegeneration: a call for global equity. Brain. 2023 Dec 1;146(12):4870-4879. doi: 10.1093/brain/awad253.
PubMed 37497623Sanborn V, Ostrand R, Ciesla J, Gunstad J. Automated assessment of speech production and prediction of MCI in older adults. Appl Neuropsychol Adult. 2022 Sep-Oct;29(5):1250-1257. doi: 10.1080/23279095.2020.1864733. Epub 2020 Dec 30.
PubMed 33377800Vinod Subramanian, Namhee Kwon, Raymond Brueckner, Nate Blaylock, Henry O'Connell,
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech-derived Digital Biomarkers for Assessing Mild Cognitive Impairment and Alzheimer's Disease Diagnosis Accuracy
- ClinicalTrials.gov ID
- NCT06994767
- Acronym / sponsor ID
- Pro2024-0418
- Conditions
- Mild Cognitive Impairment (MCI), Alzheimer Disease
- Keywords
- Vocal biomarkers, Mild Cognitive Impairment, Alzheimer's Disease, Deep machine learning, Artificial Intelligence application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Canary Speech Inc.
- Study start
- 19 May 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Cognitive Impairment (MCI) | Experimental | Other: The Canary ApplicationPatients with a mild congitive impairment |
| Alzheimer's Disease | Experimental | Other: The Canary ApplicationPatients with an Alzheimer's Disease diagnosis |
| Healthy Volunteers | Active comparator | Other: The Canary ApplicationPatients without a diagnosis of MCI or Alzheimer's, or other types of dementia |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- All participants below 50 years
- Failure to provide informed consent
- Individuals with the following medical conditions will be excluded:
- Persons with speech characteristics (heavy accents, slurring, stuttering, etc.) that would interfere with voice recording or voice analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Canary ApplicationAlso: ValidationThe CANARY application will use clinically validated survey instruments and voice recordings to measure user MCI status /Alzheimer's data. These tests are designed to evaluate a user's voice characteristics and potentially identify disease-specific patterns. | Other | Alzheimer's Disease, Healthy Volunteers, Mild Cognitive Impairment (MCI) |
Primary outcome
The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosis
Time frame: Upon enrollment
The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the sensitivity, the application diagnosis will be compared against the clinical diagnosis of the physician.
The primary objective of the study is to assess the specificity of vocal biomarkers in patients with MCI and AD diagnosis
Time frame: Upon enrollment
The CANARY application will use clinically validated survey instruments and voice recordings to analyze the data and determine the patient's MCI/ Alzheimer's disease diagnosis. The diagnosis developed by the application is the primary outcome variable. To determine the specificity, the application diagnosis will be compared against the clinical diagnosis of the physician.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 29914025Martinez-Sanchez F, Meilan JJG, Carro J, Ivanova O. A Prototype for the Voice Analysis Diagnosis of Alzheimer's Disease. J Alzheimers Dis. 2018;64(2):473-481. doi: 10.3233/JAD-180037.
- Background: PubMed 29669461Mueller KD, Hermann B, Mecollari J, Turkstra LS. Connected speech and language in mild cognitive impairment and Alzheimer's disease: A review of picture description tasks. J Clin Exp Neuropsychol. 2018 Nov;40(9):917-939. doi: 10.1080/13803395.2018.1446513. Epub 2018 Apr 19.
- Background: PubMed 37497623Garcia AM, de Leon J, Tee BL, Blasi DE, Gorno-Tempini ML. Speech and language markers of neurodegeneration: a call for global equity. Brain. 2023 Dec 1;146(12):4870-4879. doi: 10.1093/brain/awad253.
- Background: PubMed 33377800Sanborn V, Ostrand R, Ciesla J, Gunstad J. Automated assessment of speech production and prediction of MCI in older adults. Appl Neuropsychol Adult. 2022 Sep-Oct;29(5):1250-1257. doi: 10.1080/23279095.2020.1864733. Epub 2020 Dec 30.
- BackgroundVinod Subramanian, Namhee Kwon, Raymond Brueckner, Nate Blaylock, Henry O'Connell,
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sakshi Jain, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Canary Application in people with Mild Cognitive Impairment (MCI) and Alzheimer Disease, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study is to assess the sensitivity biomarkers in patients with MCI and AD diagnosis (time frame: Upon enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994767, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.