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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Greece
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Parkinson Disease Dementia
the PDD group comprised of 58 patients fulfilling the Criteria for probable PDD of the Movement Disorders Society
Diagnostic test: machine learning model
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
Diagnostic test: machine learning model
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National and Kapodistrian University of Athens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ANASTASIA BOUGEA, National and Kapodistrian University of Athens

Publications and helpful links

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General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 251ATHENS HOSPITAL

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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