- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06611475
Prediction of MMSE Scores for Cognitive Impairment
Prediction of MMSE Scores for Cognitive Impairment: A Machine Learning Analysis of Oral Health and Demographic Data in Individuals Over 60 Years of Age
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This cross-sectional study utilizes oral health and demographic data from two existing cohort studies: the European collaborative study Support Monitoring and Reminder Technology for Mild Dementia (SMART4MD) and the Swedish National Study on Aging and Care (SNAC-B). Participants aged 60 years or older will be included in the analysis. The data will be used to develop and evaluate machine learning models for predicting cognitive status.
Objectives:
- Primary Objective: To assess the potential of oral health parameters for binary classification of MMSE scores (30 vs. ≤26).
- Secondary Objective: To identify the most influential oral health parameters contributing to cognitive impairment predictions.
- Tertiary Objective: To compare the performance of Random Forest (RF), Support Vector Machine (SVM), and CatBoost (CB) classifiers in predicting MMSE scores using oral health data.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Karlskrona, Sweden, 37179
- Blekinge Institute of Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals aged 60 years or older.
- Participants with recorded oral health parameters and MMSE scores of either 30 or ≤26.
Exclusion Criteria:
- Individuals with MMSE scores of 27, 28, or 29, as these scores represent a transition phase between normal cognition and cognitive impairment, which could introduce variability.
- Individuals younger than 60 years.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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MMSE ≤26
339 participants
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A dataset comprising participants with MMSE scores of ≤26 and 30 will be used to evaluate the classification performance of various machine learning techniques.
Other Names:
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MMSE 30
354 participants
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A dataset comprising participants with MMSE scores of ≤26 and 30 will be used to evaluate the classification performance of various machine learning techniques.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection perfomance
Time Frame: 5 mounths
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The study measures the classification performance of Machine Learning classifiers.
Performance metrics, Accuracy, precision, recall, F1-Score and confusion matrix will be used for the evaluation.
The examination of the most important features relied on SHAP summary plots, providing visualizations of the influence of parameter groups on the output, organized by their importance.
This importance is based on SHAP values, offering insights into features' effects on the ML model's decision-making process
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5 mounths
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTH-6.1.1-0156-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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