A Novel Machine Learning Algorithm to Predict the Lewy Body Dementias (MLDLB)

September 8, 2020 updated by: Anastasia Bougea, National and Kapodistrian University of Athens

A Novel Machine Learning Algorithm to Predict the Lewy Body Dementias Using Clinical and Neuropsychological Scores

Parkinson's disease dementia (PDD) and Dementia with lewy bodies (DLB) are dementia syndromes that overlap in many clinical features, making their diagnosis difficult in clinical practice, particularly in advanced stages. We propose a machine learning algorithm, based only on non-invasively and easily in-the-clinic collectable predictors, to identify these disorders with a high prognostic performance.

Study Overview

Status

Unknown

Conditions

Detailed Description

The algorithm will be develop using dataset from two specialized memory centers, employing a sample of PDD and DLB subjects whose diagnostic follow-up is available for at least 3 years after the baseline assessment. A restricted set of information regarding clinico- demographic characteristics, 6 neuropsychological tests (mini mental, PD Cognitive Rating Scale, Brief Visuospatial Memory test, Symbol digit written, Wechsler adult intelligence scale, trail making A and B) was used as predictors. Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), will be investigated for their ability to predict successfully whether patients suffered from PDD or DLB.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Attiki
      • Athens, Attiki, Greece, 16674
        • Recruiting
        • Anastasia Bougea
        • Contact:
        • Sub-Investigator:
          • Christos Goumas, dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the PDD group comprised of patients fulfilling the Criteria for probable PDD and the DLB group.Patients will be enrolled from the register-based database of two clinics. The following data were collected: gender, age, education, hand dominance, Disease duration (years) and levodopa equivalent daily dose (LEDD). The burden of disease will be assess by the Movement Disorders Society-United Parkinson's Disease Rating Scale (MDS-UPDRS) part III in the Off medication state and the following six cognitive/behavioral tests: Mini-Mental State Examination (MMSE), PD- Cognitive Rating Scale (PD-CRS), Brief Visuospatial Memory test (BVMT-TR), Symbol digit written (SDMT), Trail making test (TMT A,B), Wechsler adultintelligence scale (WAIS-V). All patients will undergo brain MRI and blood test to exclude secondarycauses of dementia.

Description

Inclusion Criteria:

the PDD group comprised of patients fulfilling the Criteria for probable PDD of the Movement Disorders Society (b) the DLB group comprised of patients, according to the recent revised criteria for probable DLB .

Exclusion Criteria:

  • major psychiatrics disorders, depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson Disease Dementia
the PDD group comprised of 58 patients fulfilling the Criteria for probable PDD of the Movement Disorders Society
Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), were investigated for their ability to predict successfully whether patients suffered from PDD or DLB.
Dementia with Lewy Bodies
the DLB group comprised of 40 patients, according to the recent revised criteria for probable DLB
Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), were investigated for their ability to predict successfully whether patients suffered from PDD or DLB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMSE predictive for dlb or PDD
Time Frame: 1 year
Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), will combine these tests in order to investigate for their ability to predict successfully whether patients suffered from PDD or DLB.
1 year
Parkinson's Disease - Cognitive Rating Scale (PD-CRS) predictive for DLB or PDD
Time Frame: 1 year
Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), will combine these tests in order to investigate for their ability to predict successfully whether patients suffered from PDD or DLB.
1 year
Brief Visuospatial Memory Test (BVMT-TR) predictive for DLB or PDD
Time Frame: 1 year
Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), will combine these tests in order to investigate for their ability to predict successfully whether patients suffered from PDD or DLB.
1 year
Symbol digit written predictive for DLB or PDD
Time Frame: 1 year
Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), will combine these tests in order to investigate for their ability to predict successfully whether patients suffered from PDD or DLB.
1 year
Wechsler adult intelligence scale,predictive for DLB or PDD
Time Frame: 1 year
Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), will combine these tests in order to investigate for their ability to predict successfully whether patients suffered from PDD or DLB.
1 year
trail making A and B predictive for DLB or PDD
Time Frame: 1 year
Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), will combine these tests in order to investigate for their ability to predict successfully whether patients suffered from PDD or DLB.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ANASTASIA BOUGEA, National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

June 21, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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