Speech-derived Digital Biomarkers Study

NCT06994767 | Completed

• 1 other identifier: Pro2024-0418
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 whether the application's diagnosis is the same as the clinician's for MCI and AD patients.

Conditions

Mild Cognitive Impairment (MCI); Alzheimer Disease

Keywords

Vocal biomarkers; Mild Cognitive Impairment; Alzheimer's Disease; Deep machine learning; Artificial Intelligence application

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Upon enrollment

Study Arms (3)

Mild Cognitive Impairment (MCI)

EXPERIMENTAL

Patients with a mild congitive impairment

Other: The Canary Application

Alzheimer's Disease

EXPERIMENTAL

Patients with an Alzheimer's Disease diagnosis

Other: The Canary Application

Healthy Volunteers

ACTIVE COMPARATOR

Patients without a diagnosis of MCI or Alzheimer's, or other types of dementia

Other: The Canary Application

Interventions

The Canary Application OTHER

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.

Also known as: Validation

Alzheimer's Disease; Healthy Volunteers; Mild Cognitive Impairment (MCI)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• Subject must be able to speak and read with fluency in the English language.
• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Canary Speech Inc.: collaborator

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (5)

• 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.

  PMID: 29914025 BACKGROUND

• Mueller 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.

  PMID: 29669461 BACKGROUND

• Garcia 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.

  PMID: 37497623 BACKGROUND

• Sanborn 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.

  PMID: 33377800 BACKGROUND

• Vinod Subramanian, Namhee Kwon, Raymond Brueckner, Nate Blaylock, Henry O'Connell,

  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Validation Studies as Topic

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Evaluation Studies as Topic; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Sakshi Jain, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 29, 2025
• Study Start: May 19, 2025
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)