- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448340
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
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:
- EFTHYMIA EFTHYMIIOPOULOU, dr
- Phone Number: 00306943061632
- Email: faih.efthymiopoulou@gmail.com
-
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
Additional Relevant MeSH Terms
Other Study ID 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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