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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04448340
Other study ID # 251ATHENS HOSPITAL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date March 1, 2021

Study information

Verified date September 2020
Source National and Kapodistrian University of Athens
Contact ANASTASIA BOUGEA, DR
Phone +306930481046
Email annita139@yahoo.gr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 1, 2021
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Greece Anastasia Bougea Athens Attiki

Sponsors (1)

Lead Sponsor Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary MMSE predictive for dlb or PDD 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
Primary Parkinson's Disease - Cognitive Rating Scale (PD-CRS) predictive for DLB or PDD 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
Primary Brief Visuospatial Memory Test (BVMT-TR) predictive for DLB or PDD 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
Primary Symbol digit written predictive for DLB or PDD 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
Primary Wechsler adult intelligence scale,predictive for DLB or PDD 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
Primary trail making A and B predictive for DLB or PDD 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
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