Validation of acceXible's Automated Speech Analysis Method for the Early Detection and Monitoring of Patients With Mild Impairment or Dementia in Primary Care
Primary Purpose
Mild Cognitive Impairment, Dementia
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Speech analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- Adult patients 55+ years of age with suspected MCI or diagnosis of dementia and obtains a score greater than 20 on the MMSE.
- Patients must have agreed to participate in the study and have voluntarily signed the informed consent.
- (Healthy) Participants without a diagnosis neurological, or psychiatric disorders. Or taking medication that can affect cognitive abilities.
Exclusion Criteria
- To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.
- To have significant vision problems that would affect the ability to perceive visual stimuli.
- To have significant hearing problems that would affect the ability to understand verbal cues.
Sites / Locations
- País VascoRecruiting
Outcomes
Primary Outcome Measures
Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study.
Standard deviation of normal subjects, MCI and dementia to measure variations in language by using vocal biomarkers.
Secondary Outcome Measures
Correlation between standard cognitive test (MMSE) and linguistic variables obtained by vocal biomarkers.
With a 95% confidence interval, the correlation between standard cognitive test (MMSE score) and each of the linguistic variables is quantified.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05380297
Brief Title
Validation of acceXible's Automated Speech Analysis Method for the Early Detection and Monitoring of Patients With Mild Impairment or Dementia in Primary Care
Official Title
Validación Del método de análisis Automatizado Del Habla "AcceXible" Para la detección Temprana y Seguimiento de Pacientes Con Deterioro Cognitivo Leve o Demencia en atención Primaria.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Accexible
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration.
A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.
Thus, the purpose of this study is to validate speech analysis AI models.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Dementia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Speech analysis
Intervention Description
Speech analysis to detect and monitor mild cognitive impairment
Primary Outcome Measure Information:
Title
Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study.
Description
Standard deviation of normal subjects, MCI and dementia to measure variations in language by using vocal biomarkers.
Time Frame
Change from the baseline cognitive function at 9 months.
Secondary Outcome Measure Information:
Title
Correlation between standard cognitive test (MMSE) and linguistic variables obtained by vocal biomarkers.
Description
With a 95% confidence interval, the correlation between standard cognitive test (MMSE score) and each of the linguistic variables is quantified.
Time Frame
Through study completion, an average of 1 year.
Other Pre-specified Outcome Measures:
Title
Change of economic implications of accexible's use in a primary care center.
Description
Percentage of expenditure when using the platform.
Time Frame
Through study completion, an average of 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients 55+ years of age with suspected MCI or diagnosis of dementia and obtains a score greater than 20 on the MMSE.
Patients must have agreed to participate in the study and have voluntarily signed the informed consent.
(Healthy) Participants without a diagnosis neurological, or psychiatric disorders. Or taking medication that can affect cognitive abilities.
Exclusion Criteria
To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.
To have significant vision problems that would affect the ability to perceive visual stimuli.
To have significant hearing problems that would affect the ability to understand verbal cues.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa Maria Martín Gonzálvez
Email
ROSAMARIA.MARTINGONZALVEZ@osakidetza.eus
Facility Information:
Facility Name
País Vasco
City
País Vasco
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa María Martín Gonzálvez
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of acceXible's Automated Speech Analysis Method for the Early Detection and Monitoring of Patients With Mild Impairment or Dementia in Primary Care
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