Back to resultsShort-term Automated Longitudinal Analysis of Speech and Language in Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment, Dementia
Status
Active
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
- Centro de Prevención de Deterioro Cognitivo
Outcomes
Primary Outcome Measures
Pre-post variability of normal, MCI and dementia at both points of the study.
Through standard deviation of normal subjects, MCI and dementia, variations in language are measured by considering MMSE scores and the most significant variables of accexible's tests (image description test, phonetic verbal fluency test and semantic verbal fluency test).
Secondary Outcome Measures
Correlation between cognitive tests and language variables obtained by the platform.
Correlation between: Standard measures of cognition (e.g., MMSE score) + behavioral and psychiatric symptoms of mild cognitive impairment and language.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05340218
Brief Title
Short-term Automated Longitudinal Analysis of Speech and Language in Cognitive Impairment
Official Title
"Análisis Longitudinal Del Habla y Seguimiento a Corto Plazo de Las Facultades Cognitivas de Personas Mediante Una Serie de Pruebas: Lista de Palabras CERAD, Repite Los dígitos en Orden Inverso, TMTA-B, Prueba Del Reloj, Fluidez fonémica, comprensión Verbal Relaciones semánticas, y semánticas Alternas".
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 31, 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
Validate speech analysis AI models:
To contrast the accuracy of acceXible's platform as a screening tool in the detection of people with cognitive impairment and mild dementia.
To evaluate the correlation between automatically analyzed linguistic variables and a combination of standard measures of cognition.
To assess short-term variability in language ability among older adults, and to assess which aspects of language vary during the study period.
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
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Speech analysis
Intervention Description
Speech analysis to detect and monitor mild cognitive impairment
Primary Outcome Measure Information:
Title
Pre-post variability of normal, MCI and dementia at both points of the study.
Description
Through standard deviation of normal subjects, MCI and dementia, variations in language are measured by considering MMSE scores and the most significant variables of accexible's tests (image description test, phonetic verbal fluency test and semantic verbal fluency test).
Time Frame
Change from the baseline cognitive function at 9 months.
Secondary Outcome Measure Information:
Title
Correlation between cognitive tests and language variables obtained by the platform.
Description
Correlation between: Standard measures of cognition (e.g., MMSE score) + behavioral and psychiatric symptoms of mild cognitive impairment and language.
Time Frame
Every 6 to 9 months
Other Pre-specified Outcome Measures:
Title
Accexible's model performance.
Description
Percentage of patients classified correctly compared to the total number of sick patients, visualized at the ROC curve that allows to see the accuracy against the recall of the classifier. To contrast the accuracy of AcceXible's platform as a screening tool in the detection of people with cognitive impairment and mild dementia, a detection model has been developed from the analysis of the participants, acoustic, linguistic and semantic variables have been considered as well as audio characteristics.
Time Frame
Every 6 to 9 months
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.
Facility Information:
Facility Name
Centro de Prevención de Deterioro Cognitivo
City
Madrid
ZIP/Postal Code
28006
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Short-term Automated Longitudinal Analysis of Speech and Language in Cognitive Impairment
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