NCT04448340

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

June 21, 2020

Last Update Submit

September 8, 2020

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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

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

Interventions

machine learning modelDIAGNOSTIC_TEST

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 BodiesParkinson Disease Dementia

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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 .

You may not qualify if:

  • major psychiatrics disorders, depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anastasia Bougea

Athens, Attica, 16674, Greece

RECRUITING

Related Publications (1)

  • Bougea A, Efthymiopoulou E, Spanou I, Zikos P. A Novel Machine Learning Algorithm Predicts Dementia With Lewy Bodies Versus Parkinson's Disease Dementia Based on Clinical and Neuropsychological Scores. J Geriatr Psychiatry Neurol. 2022 May;35(3):317-320. doi: 10.1177/0891988721993556. Epub 2021 Feb 8.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • ANASTASIA BOUGEA

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ANASTASIA BOUGEA, DR

CONTACT

ANASTASIA BOUGEA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 25, 2020

Study Start

September 1, 2019

Primary Completion

October 1, 2020

Study Completion

March 1, 2021

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations